Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01185561
Status:
COMPLETED
Last Update Posted:
2016-12-14
First Post:
2010-08-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pychoeducational Intervention for Women With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'spencko@luc.edu', 'phone': '708-216-9303', 'title': 'Sue Penckofer, Ph.D.', 'organization': 'Loyola University'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'There are no limitations or caveats to report.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse data were collected for 2 years, 8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.', 'otherNumAtRisk': 38, 'otherNumAffected': 2, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Worsening mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Inpatient Hospitalization', 'notes': 'One patient was admitted inpatient for an acute stress reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Center for Epidemiologic Studies Depression (CES-D) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.'}, {'id': 'OG001', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '10.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.89', 'ciLowerLimit': '4.03', 'ciUpperLimit': '13.76', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.43', 'groupDescription': 'The null hypothesis is that there is no difference in CES-D score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is restricted to participants who completed the final study visit six months after randomization.'}, {'type': 'SECONDARY', 'title': 'State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.'}, {'id': 'OG001', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.7', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '43.6', 'spread': '12.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.82', 'ciLowerLimit': '1.29', 'ciUpperLimit': '14.37', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.27', 'groupDescription': 'The null hypothesis is that there is no difference in the State Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is restricted to participants who completed the final study visit six months after randomization.'}, {'type': 'SECONDARY', 'title': 'State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.'}, {'id': 'OG001', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.9', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '45.3', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.48', 'ciLowerLimit': '2.64', 'ciUpperLimit': '14.31', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.91', 'groupDescription': 'The null hypothesis is that there is no difference in the State Trait Anxiety Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is restricted to participants who completed the final study visit six months after randomization.'}, {'type': 'SECONDARY', 'title': 'State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.'}, {'id': 'OG001', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}], 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '14.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.85', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '-6.77', 'ciUpperLimit': '8.24', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.75', 'groupDescription': 'The null hypothesis is that there is no difference in the State Trait Anger Expression Sub-test score between those assigned to the psychoeducational intervention and those assigned to usual medical care six months after randomization.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Scores on the The State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This analysis is restricted to participants who completed the final study visit six months after randomization.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}, {'id': 'FG001', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Participants were recruited between March 2007 and November 2009', 'preAssignmentDetails': 'Eighty-four participants consented to participate in the study. Among these individuals, 10 (11.90%) were not randomized and were excluded from continuing their participation in the study because the medical monitor determined they had a significant psychiatric history, had a history of alcohol or drug abuse, or were not depressed.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Psychoeducational Intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes\n\nPsychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.'}, {'id': 'BG001', 'title': 'Usual Medical Care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '8.8', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '8.4', 'groupId': 'BG001'}, {'value': '54.4', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', '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'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '229.1', 'spread': '64.4', 'groupId': 'BG000'}, {'value': '226.9', 'spread': '48.7', 'groupId': 'BG001'}, {'value': '228.0', 'spread': '56.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pounds (lbs)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Years Living with Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '10.5', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '10.0', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '10.3', 'spread': '7.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'CES-D', 'classes': [{'categories': [{'measurements': [{'value': '27.7', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '28.9', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '28.3', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STAI Trait Anxiety Subtest', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '51.0', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STAI State Anxiety Subtest', 'classes': [{'categories': [{'measurements': [{'value': '45.8', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '47.9', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '46.8', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'STAXI Anger Expression Subtest', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '34.7', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '37.7', 'spread': '13.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants are included in the baseline analysis population.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-19', 'studyFirstSubmitDate': '2010-08-18', 'resultsFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-10-19', 'studyFirstPostDateStruct': {'date': '2010-08-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Center for Epidemiologic Studies Depression (CES-D) Score', 'timeFrame': '6 Months', 'description': 'The CES-D score was compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The CES-D is a self-report questionnaire assessing frequency and severity of depression symptoms. Scores may range from 0 to 60, where higher scores indicate worse mood.'}], 'secondaryOutcomes': [{'measure': 'State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test Score', 'timeFrame': '6 Months', 'description': 'Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) State Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI state anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.'}, {'measure': 'State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test Score', 'timeFrame': '6 Months', 'description': 'Scores on the The State-Trait Anxiety Inventory (STAI Form Y-1) Trait Anxiety Sub-test are compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAI trait anxiety subtest is a 20-item scale measuring state anxiety. Scores may range from 20 to 80 with higher scores indicating greater state anxiety.'}, {'measure': 'State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test Score', 'timeFrame': '6 Months', 'description': 'Scores on the The State-Trait Anger Expression Inventory (STAXI) Anger Expression Sub-test will be compared between those assigned to intervention versus those assigned to usual medical care six months after randomization. The STAXI anger expression subtest is a 24-item scale measuring how anger is generally being experienced and expressed. Scores may range from 0 to 72 with higher scores indicating greater anger.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes', 'SWEEP', 'Dysphoria'], 'conditions': ['Depression', 'Anxiety', 'Anger']}, 'descriptionModule': {'briefSummary': 'This proposal describes a small randomized study to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using Cognitive Behavioral Therapy (CBT). Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes.', 'detailedDescription': 'Diabetes is the fifth deadliest disease in the United States with no known cure, and cardiovascular disease (CVD) is the leading cause of death in persons with diabetes. Diabetes is the only disease that causes women to have as much heart disease as men. The relative risk of cardiac mortality has been reported to be 2.6 for women with diabetes as compared to 1.9 for men with diabetes after controlling for other cardiac risk factors. While cardiac mortality for men with diabetes has declined (13.1%), there has been a 23% increase in age-adjusted cardiac mortality for women with diabetes. This poor outcome, occurring in a time of significant advances in the management of heart disease, suggests the need to consider directing treatment at other risk factors. Depression may be one such risk factor.\n\nDepression is an independent risk factor for CVD, and is associated with poorer self-management and decreased health-related quality of life. Approximately 25% of persons with diabetes have depression, and the rate of depression in women with diabetes is double that of men with diabetes. Women with diabetes exhibit worse diabetes self-care, glycemic control, and poorer quality of life than men with diabetes, which are exacerbated by depression. Other affective symptoms including anxiety and anger commonly accompany depressive symptoms appear to impose similar risks for poor medical outcomes, and occur more often in women with diabetes than men with diabetes.\n\nResearch has shown that treatment of depression with medication and/or cognitive behavioral therapy (CBT) effectively relieves depression and improves glycemic control in persons with diabetes. More recent evidence suggests that these benefits are more durable in patients treated with CBT vs. antidepressants alone. There has been no research on "symptom clusters" (i.e., depression, anxiety, and anger) in persons with diabetes, and their effect on glycemic control and self-management. In addition, a CBT program to treat a cluster of dysphoric symptoms has not been tested in persons with diabetes. Since women with diabetes have greater depression and anxiety, worse glycemic control, and increased cardiac mortality than men with diabetes, we are proposing to test the feasibility and effectiveness of a psychoeducational intervention to promote emotional health in women with type 2 diabetes.\n\nThis proposal describes a small randomized controlled trial to determine whether usual medical care (UMC) for diabetes combined with a psychoeducational program is more effective than UMC for diabetes alone. This program differs from other diabetes programs by focusing on the management of dysphoric symptoms (depressive symptoms, anxiety, and anger). Diabetes self-care behaviors will be discussed and measured, but they are not the primary focus of the intervention. The psychoeducational program will address: 1) education about how dysphoric symptoms affect glycemic control; 2) recognition of dysphoric symptoms; and 3) management of dysphoric symptoms using CBT. A repeated measures, experimental design will be used. Subjects will be randomized to receive the group psychoeducational intervention or no additional treatment. All subjects will receive UMC for diabetes. The aims and hypotheses for the study are:\n\nPrimary Aim: To determine the effect of a psychoeducational intervention on dysphoric symptoms. The primary hypothesis is that women receiving a psychoeducational intervention plus UMC will report fewer dysphoric symptoms (depression, anxiety, and anger) at three and six months follow-up.\n\nSecondary Aim: To determine the effect of a psychoeducational intervention on glycemic control, diabetes self-management, and health-related quality of life. The secondary hypothesis is that women receiving a psychoeducational intervention plus UMC will have decreased hemoglobin A1c, report better diabetes self-management (increased self-care behaviors and self-efficacy), and report increased health-related quality of life (increased functional status, life satisfaction, and decreased diabetes-related distress) at three and six months follow-up.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 18 to 75 years;\n2. have type 2 diabetes greater than six months and being medically managed\n3. score greater than or equal to 16 on the Center for Epidemiological Studies Depression (CES-D) scale which is indicative of depressive symptoms.\n4. score greater than or equal to 12 on the CES-D plus a history of depression or currently being treated for depression.\n\nExclusion Criteria:\n\nWomen with current alcohol or substance abuse disorders, or a history of bipolar depression or any other psychotic disorder will be excluded.\n\nWomen will also be excluded if they have a diabetes knowledge test score of less than 70% and severe complications of diabetes (blindness, renal failure, or major amputation which includes most toes, foot, knee, or leg)'}, 'identificationModule': {'nctId': 'NCT01185561', 'acronym': 'SWEEP', 'briefTitle': 'A Pychoeducational Intervention for Women With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Loyola University'}, 'officialTitle': 'A Pychoeducational Intervention for Women With Diabetes', 'orgStudyIdInfo': {'id': '108324'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual medical care', 'description': 'Participants assigned to this arm represent the control group and will receive usual medical care only.'}, {'type': 'EXPERIMENTAL', 'label': 'Psychoeducational intervention', 'description': 'Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes', 'interventionNames': ['Behavioral: Psychoeducational intervention']}], 'interventions': [{'name': 'Psychoeducational intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.', 'armGroupLabels': ['Psychoeducational intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Medical Center', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}], 'overallOfficials': [{'name': 'Sue Penckofer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loyola University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loyola University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sue Penckofer', 'investigatorAffiliation': 'Loyola University'}}}}