Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT03784820
Status:
COMPLETED
Last Update Posted:
2023-04-11
First Post:
2018-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Uniting Couples in the Treatment of Binge-Eating Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hunna_watson@med.unc.edu', 'phone': '984-974-5217', 'title': 'Hunna Watson, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to COVID-related issues, the recruitment target was not reached.'}}, 'adverseEventsModule': {'timeFrame': 'From the consent date to the 6-month follow-up.', 'description': 'Adverse events (AEs) were collected by self-report, and participants, therapists, and staff shared any concerns. The investigators met biweekly with the Clinical Research Coordinator, and as needed, clinical supervisors or therapists to review participant safety. Any AE was required to be reported to the Data Safety and Monitoring Group (DSMG) immediately, and institutional review board (IRB), if appropriate. The DSMG met regularly to review safety data and maintained a record of AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'CBT-E Patients', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.\n\nCBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CBT-E Partners', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.\n\nCBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'UNITE Patients', 'description': "UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.\n\nUNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.", 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'UNITE Partners', 'description': "UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.\n\nUNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.", 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Mid-Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.35', 'ciLowerLimit': '0.04', 'ciUpperLimit': '3.27', 'pValueComment': 'Comparison of Patients at Post (T2) \\[CBT-E is the reference\\]', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.29', 'ciLowerLimit': '0.02', 'ciUpperLimit': '4.60', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3) \\[CBT-E is the reference\\]', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.20', 'ciLowerLimit': '0.18', 'ciUpperLimit': '27.39', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4) \\[CBT-E is the reference\\]', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'Binge-eating abstinence is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) and is the number of participants across study time points achieving abstinence from objective binge eating over the past 28 days. The EDE-Q measure replaces the measure in the protocol to capture a month of abstinence. The weekly binge measure was unsuitable upon review of the data because the 4 times weekly measures did not capture an exact 4-week time frame because of therapy scheduling irregularities, as verified by date-stamps of measure completion. Also, the weekly binge measure captured the past 7 days and was administered every session and once at other timepoints.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients completed this measure.'}, {'type': 'SECONDARY', 'title': 'Mean Binge-eating Frequency in Modified Intent-to-Treat Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.45', 'spread': '9.18', 'groupId': 'OG000'}, {'value': '14.50', 'spread': '15.30', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.70', 'spread': '5.31', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '2.42', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.73', 'groupId': 'OG000'}, {'value': '1.50', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.83', 'spread': '2.04', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '1.16', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '1.51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '2.09', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-1.99', 'ciUpperLimit': '2.07', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '-1.66', 'ciUpperLimit': '2.89', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'Binge-eating frequency is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) number of objective binge episodes item which spans the past 28 days. Range is 0-no upper limit, with higher frequency indicative of more severe pathology. The EDE-Q measure replaces the originally planned measure in the protocol.', 'unitOfMeasure': 'number of binge-eating episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients completed this measure.'}, {'type': 'SECONDARY', 'title': 'Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.97', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '0.68', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.89', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.77', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '1.82', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '1.66', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.18', 'spread': '0.73', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.45', 'ciUpperLimit': '0.54', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.30', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '1.06', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.31', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.98', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'Eating disorder symptomatology is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) global score. This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. The global score is obtained by summing the four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) and then dividing this sum by the number of subscales (i.e., four). The global score range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients completed this measure.'}, {'type': 'SECONDARY', 'title': 'Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.40', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '28.83', 'spread': '7.02', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.17', 'spread': '8.37', 'groupId': 'OG000'}, {'value': '17.76', 'spread': '6.20', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.56', 'spread': '4.60', 'groupId': 'OG000'}, {'value': '11.30', 'spread': '5.98', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.17', 'spread': '6.37', 'groupId': 'OG000'}, {'value': '8.17', 'spread': '4.70', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.00', 'spread': '8.10', 'groupId': 'OG000'}, {'value': '9.64', 'spread': '3.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.47', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '7.49', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.46', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.18', 'ciLowerLimit': '-3.59', 'ciUpperLimit': '7.95', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.83', 'ciLowerLimit': '-2.94', 'ciUpperLimit': '10.60', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Binge-Eating Scale is a 16-item self-report scale that assesses behavioral, affective, and attitudinal components of the subject experience of binge-eating. Item responses range from 0 to 3, with a total score range of 0 to 48. Higher sum scores indicate greater binge-eating severity and associated emotional distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.91', 'spread': '3.33', 'groupId': 'OG000'}, {'value': '17.10', 'spread': '4.75', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.11', 'spread': '2.98', 'groupId': 'OG000'}, {'value': '13.13', 'spread': '4.82', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.32', 'spread': '4.24', 'groupId': 'OG000'}, {'value': '7.38', 'spread': '4.44', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.67', 'spread': '6.41', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '4.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '-3.14', 'ciUpperLimit': '5.25', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.83', 'ciLowerLimit': '-4.07', 'ciUpperLimit': '7.73', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)', 'description': 'The Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The total score range is 0 to 40. Higher scores indicate greater severity of compulsive behaviors and preoccupations related to binge-eating.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. 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[{'measurements': [{'value': '72.33', 'spread': '24.47', 'groupId': 'OG000'}, {'value': '66.00', 'spread': '17.34', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.17', 'spread': '18.76', 'groupId': 'OG000'}, {'value': '61.43', 'spread': '16.40', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '-16.73', 'ciUpperLimit': '20.19', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.47', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.94', 'ciLowerLimit': '-13.59', 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It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.36', 'spread': '5.52', 'groupId': 'OG000'}, {'value': '16.60', 'spread': '5.85', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.89', 'spread': '5.58', 'groupId': 'OG000'}, {'value': '19.38', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.86', 'spread': '4.14', 'groupId': 'OG000'}, {'value': '16.71', 'spread': '5.35', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.83', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '6.99', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.17', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '18.29', 'spread': '8.69', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.73', 'spread': '8.60', 'groupId': 'OG000'}, {'value': '15.40', 'spread': '4.95', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.71', 'spread': '10.40', 'groupId': 'OG000'}, {'value': '16.63', 'spread': '5.10', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.17', 'spread': '8.84', 'groupId': 'OG000'}, {'value': '15.75', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.17', 'spread': '11.30', 'groupId': 'OG000'}, {'value': '14.38', 'spread': '4.60', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.33', 'spread': '9.67', 'groupId': 'OG000'}, {'value': '12.71', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.27', 'ciLowerLimit': '-5.02', 'ciUpperLimit': '4.47', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.73', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '9.81', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '-5.73', 'ciUpperLimit': '9.23', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.05', 'ciLowerLimit': '-8.21', 'ciUpperLimit': '4.12', 'groupDescription': 'Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.07', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.62', 'ciLowerLimit': '-13.74', 'ciUpperLimit': '0.51', 'pValueComment': 'Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.64', 'ciLowerLimit': '-12.73', 'ciUpperLimit': '-0.56', 'pValueComment': 'Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': "The partner version of the Difficulties in Emotion Regulation Scale is an 8-item modified version of the DERS. It is a self-report scale that assesses perceptions of one's partner's emotion regulation ability and skills. Three items from the Impulse Control Difficulties (ICD) and 5 items from the Emotion Regulation Strategies (ERS) subscale were administered. Item responses range from 1 to 5 and the total score is the sum of the items. The total score range is 8 to 40. Higher scores indicate more (perceived) difficulties in one's partner's emotion regulation.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112.27', 'spread': '15.31', 'groupId': 'OG000'}, {'value': '109.60', 'spread': '18.84', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '115.44', 'spread': '12.13', 'groupId': 'OG000'}, {'value': '112.00', 'spread': '18.50', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.29', 'spread': '19.76', 'groupId': 'OG000'}, {'value': '119.29', 'spread': '14.04', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113.67', 'spread': '23.96', 'groupId': 'OG000'}, {'value': '112.75', 'spread': '17.77', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '114.17', 'spread': '26.13', 'groupId': 'OG000'}, {'value': '116.43', 'spread': '15.98', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.27', 'spread': '14.95', 'groupId': 'OG000'}, {'value': '116.00', 'spread': '16.75', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112.14', 'spread': '16.63', 'groupId': 'OG000'}, {'value': '112.71', 'spread': '14.31', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111.17', 'spread': '7.88', 'groupId': 'OG000'}, {'value': '119.43', 'spread': '16.00', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '110.67', 'spread': '7.12', 'groupId': 'OG000'}, {'value': '117.83', 'spread': '17.93', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '112.50', 'spread': '9.77', 'groupId': 'OG000'}, {'value': '114.00', 'spread': '21.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '-13.43', 'ciUpperLimit': '15.19', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.95', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.64', 'ciLowerLimit': '-18.95', 'ciUpperLimit': '17.66', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '-17.17', 'ciUpperLimit': '19.90', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.39', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.81', 'ciLowerLimit': '-7.37', 'ciUpperLimit': '18.98', 'groupDescription': 'Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.29', 'ciLowerLimit': '-7.26', 'ciUpperLimit': '19.84', 'pValueComment': 'Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.55', 'ciLowerLimit': '-20.00', 'ciUpperLimit': '16.91', 'pValueComment': 'Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Dyadic Adjustment Scale is a 32-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 151. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed'}, {'type': 'SECONDARY', 'title': 'Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.91', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '16.30', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.33', 'spread': '1.66', 'groupId': 'OG000'}, {'value': '16.13', 'spread': '2.70', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.71', 'spread': '3.04', 'groupId': 'OG000'}, {'value': '17.00', 'spread': '2.83', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.33', 'spread': '2.42', 'groupId': 'OG000'}, {'value': '16.13', 'spread': '3.48', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.00', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '17.43', 'spread': '2.76', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.82', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '15.90', 'spread': '3.11', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.86', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '15.50', 'spread': '1.93', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '1.37', 'groupId': 'OG000'}, {'value': '17.13', 'spread': '2.17', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.83', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '17.25', 'spread': '2.25', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.00', 'spread': '2.19', 'groupId': 'OG000'}, {'value': '17.29', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.27', 'ciLowerLimit': '-2.29', 'ciUpperLimit': '2.83', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.82', 'ciLowerLimit': '-3.66', 'ciUpperLimit': '2.01', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.67', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-2.15', 'ciUpperLimit': '3.35', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.46', 'ciLowerLimit': '-1.43', 'ciUpperLimit': '2.35', 'pValueComment': 'Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.44', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '3.70', 'pValueComment': 'Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG000'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '-1.14', 'ciUpperLimit': '3.28', 'pValueComment': 'Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Dyadic Adjustment Scale-Short Form (DAS-4) is a 4-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 21. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0) Patients, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.55', 'spread': '6.65', 'groupId': 'OG000'}, {'value': '20.70', 'spread': '10.94', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.33', 'spread': '8.90', 'groupId': 'OG000'}, {'value': '18.38', 'spread': '8.37', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.57', 'spread': '9.62', 'groupId': 'OG000'}, {'value': '15.29', 'spread': '11.64', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '7.61', 'groupId': 'OG000'}, {'value': '12.88', 'spread': '6.83', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.00', 'spread': '5.93', 'groupId': 'OG000'}, {'value': '13.43', 'spread': '7.96', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.36', 'spread': '8.09', 'groupId': 'OG000'}, {'value': '14.50', 'spread': '8.75', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.57', 'spread': '8.32', 'groupId': 'OG000'}, {'value': '16.50', 'spread': '6.57', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.83', 'spread': '9.79', 'groupId': 'OG000'}, {'value': '12.25', 'spread': '5.28', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.00', 'spread': '9.06', 'groupId': 'OG000'}, {'value': '14.13', 'spread': '6.85', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners, Demand/Withdraw subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.33', 'spread': '6.28', 'groupId': 'OG000'}, {'value': '14.71', 'spread': '8.40', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Patients, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.45', 'spread': '6.98', 'groupId': 'OG000'}, {'value': '16.40', 'spread': '4.67', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.56', 'spread': '7.26', 'groupId': 'OG000'}, {'value': '16.00', 'spread': '5.24', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.86', 'spread': '5.84', 'groupId': 'OG000'}, {'value': '21.86', 'spread': '4.22', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.83', 'spread': '9.33', 'groupId': 'OG000'}, {'value': '20.38', 'spread': '4.84', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.33', 'spread': '9.29', 'groupId': 'OG000'}, {'value': '21.43', 'spread': '3.64', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.18', 'spread': '6.03', 'groupId': 'OG000'}, {'value': '20.20', 'spread': '3.97', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.57', 'spread': '4.47', 'groupId': 'OG000'}, {'value': '20.50', 'spread': '3.46', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.83', 'spread': '4.79', 'groupId': 'OG000'}, {'value': '22.88', 'spread': '2.95', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.17', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '20.75', 'spread': '4.23', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners, Constructive Communication subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.33', 'spread': '5.28', 'groupId': 'OG000'}, {'value': '21.86', 'spread': '4.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.42', 'ciLowerLimit': '-13.36', 'ciUpperLimit': '6.52', 'pValueComment': 'Demand/Withdraw score: Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-7.49', 'ciUpperLimit': '6.54', 'pValueComment': 'Demand/Withdraw Score: Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-7.56', 'ciUpperLimit': '6.30', 'pValueComment': 'Demand/Withdraw Score: Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.55', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '6.93', 'pValueComment': 'Constructive Communication Score: Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '-4.83', 'ciUpperLimit': '8.92', 'pValueComment': 'Constructive Communication Score: Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.13', 'ciLowerLimit': '-3.27', 'ciUpperLimit': '9.54', 'pValueComment': 'Constructive Communication Score: Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.24', 'ciLowerLimit': '-19.05', 'ciUpperLimit': '-1.42', 'pValueComment': 'Demand/Withdraw score: Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.98', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-8.18', 'ciUpperLimit': '7.95', 'pValueComment': 'Demand/Withdraw score: Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.20', 'ciLowerLimit': '-10.10', 'ciUpperLimit': '5.70', 'pValueComment': 'Demand/Withdraw score: Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.41', 'ciLowerLimit': '-0.99', 'ciUpperLimit': '5.82', 'pValueComment': 'Constructive Communication Score: Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.12', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.94', 'ciLowerLimit': '-1.05', 'ciUpperLimit': '8.93', 'pValueComment': 'Constructive Communication Score: Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.26', 'ciLowerLimit': '-2.35', 'ciUpperLimit': '6.87', 'pValueComment': 'Constructive Communication Score: Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Communication Patterns Questionnaire-Short Form (modified for Binge-Eating Disorder) assesses how the couple communicates about binge-eating when the issue arises and when discussing the issue. Item responses range from 1 to 9. The three subscales measured are Self Demand/Partner Withdraw (3 items), Partner Demand/Self Withdraw (3 items), and Constructive Communication (3 items). The Demand/Withdraw subscales were combined and have a score range of 6 to 54 and the Constructive Communication subscale has a score range of 3 to 27. Higher (subscale) sum scores indicate more of those types of behaviors, respectively; high scores on the Demand/Withdraw and low scores on the Constructive Communication subscale are worse, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.22', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.55', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.44', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.45', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.36', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.51', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.43', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '0.51', 'spread': '0.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.09', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '0.53', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.90', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.48', 'ciUpperLimit': '0.42', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.31', 'ciUpperLimit': '0.82', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': "The Eating Disorder Quality of Life questionnaire is a self-report 25-item health-related quality of life questionnaire that measures the perceived extent to which the eating disorder affects the subject's quality of life in different domains. Item responses range from 0 to 4, with a possible score range of 0 to 100. Higher scores indicate lower quality of life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.64', 'spread': '4.23', 'groupId': 'OG000'}, {'value': '7.20', 'spread': '5.65', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.22', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '8.25', 'spread': '5.01', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.14', 'spread': '4.74', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '5.64', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.17', 'spread': '4.45', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '5.83', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.17', 'spread': '5.85', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.18', 'spread': '6.40', 'groupId': 'OG000'}, {'value': '6.33', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.14', 'spread': '5.40', 'groupId': 'OG000'}, {'value': '7.25', 'spread': '6.61', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.50', 'spread': '5.89', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '5.55', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.00', 'spread': '5.62', 'groupId': 'OG000'}, {'value': '6.00', 'spread': '5.37', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.50', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '5.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-5.10', 'ciUpperLimit': '4.43', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '-4.14', 'ciUpperLimit': '5.04', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.72', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.85', 'ciLowerLimit': '-5.54', 'ciUpperLimit': '3.85', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.05', 'ciLowerLimit': '-8.73', 'ciUpperLimit': '2.63', 'pValueComment': 'Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.69', 'ciLowerLimit': '-9.90', 'ciUpperLimit': '0.51', 'pValueComment': 'Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.19', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.29', 'ciLowerLimit': '-8.23', 'ciUpperLimit': '1.65', 'pValueComment': 'Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study, the investigators examined the Problem-Solving Communication scale (PSC - 19 items), which measures the inability to resolve differences in the relationship. PSC scores range from 0-19 with higher scores indicating poorer problem-solving communication skills.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Pre (T0) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.09', 'spread': '3.36', 'groupId': 'OG000'}, {'value': '4.30', 'spread': '3.71', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '3.84', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '4.29', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.57', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.17', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '4.50', 'spread': '3.34', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.33', 'spread': '4.80', 'groupId': 'OG000'}, {'value': '3.14', 'spread': '2.48', 'groupId': 'OG001'}]}]}, {'title': 'Pre (T0) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.36', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '2.50', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'Mid-Treatment (T1) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '2.37', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.83', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '3.20', 'groupId': 'OG001'}]}]}, {'title': '3 Month Fup (T3) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.83', 'spread': '3.06', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '2.60', 'groupId': 'OG001'}]}]}, {'title': '6 Month Fup (T4) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '3.10', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '1.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-4.08', 'ciUpperLimit': '1.67', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-2.87', 'ciUpperLimit': '3.54', 'pValueComment': 'Comparison of Patients at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-4.76', 'ciUpperLimit': '2.34', 'pValueComment': 'Comparison of Patients at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.52', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.09', 'ciLowerLimit': '-4.43', 'ciUpperLimit': '2.24', 'pValueComment': 'Comparison of Partners at Post (T2)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-3.96', 'ciUpperLimit': '1.21', 'pValueComment': 'Comparison of Partners at 3 Month Fup (T3)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.52', 'ciLowerLimit': '-4.78', 'ciUpperLimit': '-0.25', 'pValueComment': 'Comparison of Partners at 6 Month Fup (T4)', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study the investigators examined the 13-item Affective Communication scale (ACS), which assesses general communication. ACS scores range from 0-13 with higher scores indicating poorer affective communication skills.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Both patients and partners completed this measure. Participants who provided data were analyzed. Some participants provided partial data at study time points, further, one participant was no longer in a relationship for midpoint-6 month follow-up (T1-T4) assessments and thus, did not complete couple-based measures; this explains discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'SECONDARY', 'title': 'Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.'}, {'id': 'OG001', 'title': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.'}], 'classes': [{'title': 'Post (T2) Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.71', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '29.24', 'spread': '3.55', 'groupId': 'OG001'}]}]}, {'title': 'Post (T2) Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.38', 'spread': '2.56', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '-3.66', 'ciUpperLimit': '4.72', 'pValueComment': 'Comparison of Patients at Post (T2)', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Post (after 16 weekly treatment sessions) (T2)', 'description': 'Treatment acceptability was measured with the 8-item Client Satisfaction Questionnaire, a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate greater treatment satisfaction (acceptability). An independent samples t test was conducted.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients in CBT-E and UNITE, and partners in UNITE, completed this measure. CBT-E partners did not complete this measure as they did not receive any treatment. Participants who provided data were analyzed. Some participants provided partial data at study time points, explaining discrepancy(ies) between the mITT Participant Flow N and N analyzed.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Couple Communication Measured by Observational Coding of Recorded Couple Conversations', 'timeFrame': 'From Pre-treatment through Follow-up', 'description': "Couple communication will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS), observational coding systems that assess communication behaviors, affective expression, and supportive behavior.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Couple Interpersonal Problem-solving/Behavior Change Skills Measured by Observational Coding of a Recorded Couple Conversation', 'timeFrame': 'From Pre-treatment through Follow-up', 'description': "Couple interpersonal problem-solving/behavior change skills will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to problem-solve on some aspect of the patient's binge-eating disorder and attempt to agree upon behavioral changes that they will make. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS).", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Partner-assisted Emotion Regulation Assessed With Vocally Encoded Emotional Arousal', 'timeFrame': 'From Pre-treatment through Follow-up', 'description': "Two 10-minute video-taped interactions during which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder and to problem-solve on some aspect of the patient's binge-eating disorder, respectively. Vocally encoded emotional arousal will be measured using fundamental frequency (f0) from patients' and partners' speech. F0 is a spectral analysis-based measure of speech prosody that refers to the lowest frequency harmonic of the speech sound wave, created by the opening and closing of the vocal folds while air flows outward from the lungs during speech production. Emotion regulation is indicated by one's ability to return to a stable set-point after being perturbed from that set-point. Stronger regulation is indicated by a faster return to the set-point. The range of fundamental frequency for speech in adult men and women is approximately 75-300hz.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBT-E - Patients', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.\n\nCBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).'}, {'id': 'FG001', 'title': 'CBT-E - Partners', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.\n\nCBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).'}, {'id': 'FG002', 'title': 'UNITE - Patients', 'description': "UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.\n\nUNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues."}, {'id': 'FG003', 'title': 'UNITE - Partners', 'description': "UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.\n\nUNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Pre (T0) Intent-to-Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '11'}]}, {'type': 'Mid-Treatment (T1) Intent-to-Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Post (T2) Intent-to-Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': '3 Month Fup (T3) Intent-to-Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': '6 Month Fup (T4) Intent-to-Treat (ITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Pre (T0) Modified Intent-to-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Mid-Treatment (T1) Modified Intent-to-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Post (T2) Modified Intent-to-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': '3 Month Fup (T3) Modified Intent-to-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': '6 Month Fup (T4) Modified Intent-to-Treat (mITT)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants were recruited between September 2018 to January 2021 from local physician offices, social media, advertisements, and local listservs. Potential participants were asked to contact the Research Coordinator for more information. Potential participants completed a screening questionnaire by phone with the Research Coordinator. The setting for the study was an outpatient clinic at the University of North Carolina at Chapel Hill.', 'preAssignmentDetails': 'After consenting to participate and completing an initial phone screening, participants were asked to complete a pre-treatment assessment consisting of electronic questionnaires and an in-person interview to determine study eligibility. The patient with binge-eating disorder (BED) in each couple had to provide written certification from their primary care provider (PCP) that their health status was suitable for this study. After determining eligibility, patients were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.\n\nCBT-E: CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).'}, {'id': 'BG001', 'title': 'UNITE', 'description': "UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.\n\nUNITE: UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.00', 'spread': '11.97', 'groupId': 'BG000'}, {'value': '40.27', 'spread': '10.31', 'groupId': 'BG001'}, {'value': '41.14', 'spread': '10.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Subtotals for patients and partners are provided.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The overall number of participants is equal to the number of patients and partners combined.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Race: White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Race: Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Race: White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Race: Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'The overall number of participants is equal to the number of patients and partners combined.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Patients with binge-eating disorder and their partners who satisfied study inclusion and exclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-29', 'size': 739117, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-11T22:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to either couple therapy (UNITE) or individual therapy (CBT-E) for binge-eating disorder and will receive 16 1-hour sessions of the respective treatment. All study hypotheses will be tested using recommended Intent-To-Treat (ITT) methods. Differential treatment effects in individual functioning variables will be tested using 2 (time) x 2 (treatment) mixed-effect ANOVAs for binge-purge frequency and eating disorder outcomes and 2 (partner) x 3 (time) x 2 (treatment) mixed-effect ANOVAs for psychological outcomes. (Some variables will have 4 time points). Differential treatment effects in target relationship variables will be tested using 2 (partner) x 2 (time) x 2 (treatment) mixed-effect ANOVAs for all outcomes except vocally encoded emotional arousal. Differential treatment effects of vocally encoded emotional arousal will be tested using repeated-measures Actor Partner Interdependence Models (RM-APIMS).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2018-12-19', 'resultsFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-15', 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Couple Communication Measured by Observational Coding of Recorded Couple Conversations', 'timeFrame': 'From Pre-treatment through Follow-up', 'description': "Couple communication will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS), observational coding systems that assess communication behaviors, affective expression, and supportive behavior."}, {'measure': 'Couple Interpersonal Problem-solving/Behavior Change Skills Measured by Observational Coding of a Recorded Couple Conversation', 'timeFrame': 'From Pre-treatment through Follow-up', 'description': "Couple interpersonal problem-solving/behavior change skills will be assessed by rating of a 10-minute videotaped conversation in which the couple is asked to problem-solve on some aspect of the patient's binge-eating disorder and attempt to agree upon behavioral changes that they will make. Scoring will be based on the Couples Interaction Rating System (CIRS) and Social Support Interaction Rating System (SSIRS)."}, {'measure': 'Partner-assisted Emotion Regulation Assessed With Vocally Encoded Emotional Arousal', 'timeFrame': 'From Pre-treatment through Follow-up', 'description': "Two 10-minute video-taped interactions during which the couple is asked to share thoughts, feelings, and concerns about some aspect of the patient's binge-eating disorder and to problem-solve on some aspect of the patient's binge-eating disorder, respectively. Vocally encoded emotional arousal will be measured using fundamental frequency (f0) from patients' and partners' speech. F0 is a spectral analysis-based measure of speech prosody that refers to the lowest frequency harmonic of the speech sound wave, created by the opening and closing of the vocal folds while air flows outward from the lungs during speech production. Emotion regulation is indicated by one's ability to return to a stable set-point after being perturbed from that set-point. Stronger regulation is indicated by a faster return to the set-point. The range of fundamental frequency for speech in adult men and women is approximately 75-300hz."}], 'primaryOutcomes': [{'measure': 'Number of Modified Intent-to-Treat Patients With Binge-eating Abstinence', 'timeFrame': 'Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'Binge-eating abstinence is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) and is the number of participants across study time points achieving abstinence from objective binge eating over the past 28 days. The EDE-Q measure replaces the measure in the protocol to capture a month of abstinence. The weekly binge measure was unsuitable upon review of the data because the 4 times weekly measures did not capture an exact 4-week time frame because of therapy scheduling irregularities, as verified by date-stamps of measure completion. Also, the weekly binge measure captured the past 7 days and was administered every session and once at other timepoints.'}], 'secondaryOutcomes': [{'measure': 'Mean Binge-eating Frequency in Modified Intent-to-Treat Patients', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'Binge-eating frequency is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) number of objective binge episodes item which spans the past 28 days. Range is 0-no upper limit, with higher frequency indicative of more severe pathology. The EDE-Q measure replaces the originally planned measure in the protocol.'}, {'measure': 'Mean Eating Disorder Examination-Questionnaire (EDE-Q) Global Score in Modified Intent-to-Treat Patients', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'Eating disorder symptomatology is measured using the Eating Disorder Examination-Questionnaire (EDE-Q) global score. This self-report questionnaire assesses the presence and degree of specific psychopathology associated with eating disorders over the previous 28 days. The global score is obtained by summing the four subscale scores (Restraint, Eating Concern, Shape Concern, and Weight Concern) and then dividing this sum by the number of subscales (i.e., four). The global score range is 0 - 6. Higher scores are indicative of greater eating disorder symptomatology (i.e., worse outcome).'}, {'measure': 'Mean Binge-Eating Scale (BES) Total Score in Modified Intent-to-Treat Patients', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Binge-Eating Scale is a 16-item self-report scale that assesses behavioral, affective, and attitudinal components of the subject experience of binge-eating. Item responses range from 0 to 3, with a total score range of 0 to 48. Higher sum scores indicate greater binge-eating severity and associated emotional distress.'}, {'measure': 'Mean Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating (YBOCS-BE) Total Score in Modified Intent-to-Treat Patients', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 6 Month Fup (T4)', 'description': 'The Yale-Brown Obsessive-Compulsive Scale Modified for Binge-Eating measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). The total score range is 0 to 40. Higher scores indicate greater severity of compulsive behaviors and preoccupations related to binge-eating.'}, {'measure': 'Mean Beck-Depression Inventory-II (BDI-II) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Beck Depression Inventory-II (BDI-II) is one of the most widely used self-report measures of depressive symptoms. It includes 21 self-report items. Total scores range from 0 to 63, and higher scores indicate higher levels of depressive symptoms'}, {'measure': 'Mean Beck Anxiety Inventory-II (BAI-II) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Beck-Anxiety Inventory-II (BAI) is a self-report measure that assesses different aspects of the anxiety experience (e.g., physiological, cognitive, behavioral). The total score ranges from 0 to 63 with higher scores indicative of greater anxiety symptoms.'}, {'measure': 'Mean Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Difficulties in Emotion Regulation Scale is a 36-item self-report scale that assesses emotion regulation. Item responses range from 1 to 5, with a total score range of 36 to 180. Higher scores indicate more difficulties in emotion regulation.'}, {'measure': 'Mean Partner Difficulties in Emotion Regulation Scale (DERS) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': "The partner version of the Difficulties in Emotion Regulation Scale is an 8-item modified version of the DERS. It is a self-report scale that assesses perceptions of one's partner's emotion regulation ability and skills. Three items from the Impulse Control Difficulties (ICD) and 5 items from the Emotion Regulation Strategies (ERS) subscale were administered. Item responses range from 1 to 5 and the total score is the sum of the items. The total score range is 8 to 40. Higher scores indicate more (perceived) difficulties in one's partner's emotion regulation."}, {'measure': 'Mean Dyadic Adjustment Scale (DAS-32) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Dyadic Adjustment Scale is a 32-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 151. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.'}, {'measure': 'Mean Dyadic Adjustment Scale-Short Form (DAS-4) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Dyadic Adjustment Scale-Short Form (DAS-4) is a 4-item self-report scale that assesses the quality of the relationship as perceived by participants. The total score range is 0 to 21. Higher scores indicate higher dyadic adjustment within the relationship and greater relationship satisfaction.'}, {'measure': 'Mean Communication Patterns Questionnaire-Short Form (CPQ-SF) Subscale Scores in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'The Communication Patterns Questionnaire-Short Form (modified for Binge-Eating Disorder) assesses how the couple communicates about binge-eating when the issue arises and when discussing the issue. Item responses range from 1 to 9. The three subscales measured are Self Demand/Partner Withdraw (3 items), Partner Demand/Self Withdraw (3 items), and Constructive Communication (3 items). The Demand/Withdraw subscales were combined and have a score range of 6 to 54 and the Constructive Communication subscale has a score range of 3 to 27. Higher (subscale) sum scores indicate more of those types of behaviors, respectively; high scores on the Demand/Withdraw and low scores on the Constructive Communication subscale are worse, respectively.'}, {'measure': 'Mean Eating Disorder Quality of Life Questionnaire (EDQOL) Total Score in Modified Intent-to-Treat Patients', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': "The Eating Disorder Quality of Life questionnaire is a self-report 25-item health-related quality of life questionnaire that measures the perceived extent to which the eating disorder affects the subject's quality of life in different domains. Item responses range from 0 to 4, with a possible score range of 0 to 100. Higher scores indicate lower quality of life."}, {'measure': 'Mean Problem-Solving/Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study, the investigators examined the Problem-Solving Communication scale (PSC - 19 items), which measures the inability to resolve differences in the relationship. PSC scores range from 0-19 with higher scores indicating poorer problem-solving communication skills.'}, {'measure': 'Mean Affective Communication Subscale Score of the Marital Satisfaction Inventory-Revised (MSI-R) in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Pre (T0), Mid-Treatment (after 8 weekly treatment sessions) (T1), Post (after 16 weekly treatment sessions) (T2), 3 Month Fup (T3), 6 Month Fup (T4)', 'description': 'This revised version of the Marital Satisfaction Inventory is a 150-item true/false self-report assessment of marital distress. For the purposes of this study the investigators examined the 13-item Affective Communication scale (ACS), which assesses general communication. ACS scores range from 0-13 with higher scores indicating poorer affective communication skills.'}, {'measure': 'Mean Client Satisfaction Questionnaire-8 (CSQ-8) Total Score in Modified Intent-to-Treat Patients and Partners', 'timeFrame': 'Post (after 16 weekly treatment sessions) (T2)', 'description': 'Treatment acceptability was measured with the 8-item Client Satisfaction Questionnaire, a validated acceptability measure. Item responses run on a scale of 1 to 4, with a total score range of 8-32. Higher scores indicate greater treatment satisfaction (acceptability). An independent samples t test was conducted.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Binge-Eating Disorder', 'Eating disorders', 'Couple therapy', 'CBT'], 'conditions': ['Binge-Eating Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the feasibility, acceptability, and preliminary effectiveness of a novel couple-based intervention for binge-eating disorder (BED) relative to an established evidence-based individual treatment (cognitive-behavioral therapy-enhanced; CBT-E) in a community clinic setting.', 'detailedDescription': "Clinicians' options for BED treatment are inadequate. Treatments for BED have demonstrated efficacy in controlled settings with specialist therapists and expert supervision, but much less in known about the effectiveness of BED interventions and whether the transition of evidence-based treatments to the community results in poorer outcomes. UNITE activates a key resource by incorporating an important part of the patient's social environment (the partner) into treatment. The investigators hypothesize that UNITE will show preliminary evidence of being superior to CBT-E in achieving binge abstinence via engaging ED-related relationship targets, including improved (a) communication around the disorder, (b) disorder-specific interpersonal problem-solving/ behavioral change skills, and (c) partner-assisted emotion regulation. The investigators will assess targeted relationship domains with observational and speech prosody measures during clinic interactions and self-reports reflecting experiences outside the clinic. Because the couple is learning how to work together to address BED, the investigators hypothesize that maintenance of gains will show evidence consistent with superiority in UNITE."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* current Diagnostic and Statistic Manual (DSM-5) criteria for binge-eating disorder (patient only)\n* at least 18 years of age\n* English speaking and able to read\n* in a committed relationship for at least 6 months regardless of sexual orientation\n* live with partner (or are interact with each other daily)\n* partner willingness to participate in treatment\n* able to travel to Chapel Hill, North Carolina weekly for treatment\n\nExclusion Criteria:\n\n* alcohol or drug dependence in the past year\n* current anorexia nervosa\n* current significant suicidal ideation with active suicidal intent\n* severe depression that would seriously interfere with functional capacity\n* developmental disability that would impair the ability to benefit from the intervention\n* any psychosis, schizophrenia, or bipolar I disorder, unless stably remitted on maintenance therapy for at least 1 year\n* moderate to high reported levels of physical violence from either partner\n* unwillingness to forgo non-protocol concurrent couple therapy or individual therapy (patient only)\n* previously participated in the UNITE pilot trial'}, 'identificationModule': {'nctId': 'NCT03784820', 'acronym': 'UNITE', 'briefTitle': 'Uniting Couples in the Treatment of Binge-Eating Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Targeting Relationship Domains in Community-Based Treatment of Binge-Eating Disorder', 'orgStudyIdInfo': {'id': '18-1379'}, 'secondaryIdInfos': [{'id': '1R34MH113681-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R34MH113681-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UNITE', 'description': 'UNITE is a manualized cognitive-behavioral couple therapy (CBCT) intervention that engages the couple to address the core psychopathology of BED.', 'interventionNames': ['Behavioral: UNITE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT-E', 'description': 'CBT-E is a trans-diagnostic cognitive behavioral individual therapy treatment for eating disorders. It has been shown to be effective in numerous controlled and open trials.', 'interventionNames': ['Behavioral: CBT-E']}], 'interventions': [{'name': 'UNITE', 'type': 'BEHAVIORAL', 'description': "UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.", 'armGroupLabels': ['UNITE']}, {'name': 'CBT-E', 'type': 'BEHAVIORAL', 'description': 'CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).', 'armGroupLabels': ['CBT-E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Cynthia Bulik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Donald Baucom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'ANALYTIC_CODE'], 'timeFrame': 'Data as described above will be made available 12 months after publication of the primary outcome paper.', 'ipdSharing': 'YES', 'description': 'It is our intention to make data available to the general scientific community at the conclusion of the clinical trial. Given the fact that most of the entities involved in this application must be HIPAA compliant, deidentification of data along HIPAA guidelines will guide the development of the final database to be shared. The current plan would be to have the dataset available via the web through postings of the information on the Academy for Eating Disorders, the Eating Disorders Research Society, and the Association for Behavioral and Cognitive Therapy websites. Data will be provided in SAS and SPSS formats. The investigators will provide a detailed protocol and a code book. The availability of the de-identified data on these web pages would be announced in journals and publications of interest to clinicians and researchers in the areas of eating disorders, couple therapy, and cognitive-behavioral therapy.', 'accessCriteria': 'IRB approval for secondary data analysis, an executed data sharing agreement with UNC-CH and approval by principal investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of Utah', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}