Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT05540704
Status:
RECRUITING
Last Update Posted:
2025-10-21
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling for Problematic Eating and Weight Control in Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000098322', 'term': 'Disordered Eating Behavior'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}, {'id': 'D000080887', 'term': 'Diabulimia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Assessors are blinded to the participant's assignment/condition. All study team members are blinded to the randomization schedule."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Working Alliance Inventory - Short Revised', 'timeFrame': 'Mid-treatment', 'description': 'This is a 13-item self-report questionnaire that measures experiences individuals have with their therapy or therapist. It includes three subscale scores: goal items, task items, and bond items. It is included as a potential moderator of treatment effects.'}], 'primaryOutcomes': [{'measure': 'Change in glycemic control as indexed by continuous glucose monitoring (CGM)', 'timeFrame': 'baseline, 6 weeks, 12 weeks, 36 weeks', 'description': 'CGM indices of time in range, frequency of Level 1 and 2 hyperglycemia and blood glucose variability'}, {'measure': 'Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)', 'timeFrame': 'baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks', 'description': 'Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).'}, {'measure': 'Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire', 'timeFrame': 'baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks', 'description': 'Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.'}, {'measure': 'Change in glycemic control as indexed by hemoglobin A1c (HbA1c)', 'timeFrame': 'baseline, 24 weeks, 36 weeks', 'description': 'Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)'}], 'secondaryOutcomes': [{'measure': 'Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale', 'timeFrame': 'baseline, 12 weeks, 24 weeks, 36 weeks', 'description': 'Feelings of stress or overwhelm with the burden of living with diabetes and diabetes management. Scores range from 1-6, with higher scores indicating greater distress (worse outcome)'}, {'measure': 'CompACT-10', 'timeFrame': 'Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.', 'description': 'A 10-item measure of general (rather than diabetes-specific) psychological flexibility. This measure includes component processes of open, aware and engaged, allowing for more in-depth assessment of process of change. This is the primary psychological flexibility measure in the current trial.'}, {'measure': 'Acceptance and Action Diabetes Questionnaire (AADQ)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks', 'description': 'Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.'}, {'measure': 'Valuing Questionnaire (VQ)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks', 'description': 'Assesses outcomes expected in an ACT intervention. The VQ consists of 2 Subscales: Values Obstruction and Values Progress. Values Obstruction measures the extent to which thoughts/feelings obstructed engagement in values. Values Progress measures the extent to which an individual made progress in areas of life that are important to them.'}, {'measure': 'Executive function', 'timeFrame': 'Baseline, 12 weeks, 36 weeks', 'description': 'Computer-administered Stroop and a GoNoGo paradigm. Outcomes of interest are interference or bias score and errors and reaction time (respectively). These measures are included to test the hypothesis that executive function is improved with the improvement of eating disorder symptoms and glycemic control.'}, {'measure': 'High Frequency Heart Rate Variability (HF-HRV)', 'timeFrame': 'Baseline, 12 weeks, 36 weeks', 'description': 'Assesses physiological flexibility/adaptability in the presence of emotional stimuli as an exploratory process of change measure.'}, {'measure': 'Actigraphy', 'timeFrame': 'Baseline, 12 weeks, 36 weeks', 'description': 'Measures sleep and physical activity as exploratory measures of behavioral mechanisms of change.'}, {'measure': 'Ecological Momentary Assessment (EMA)', 'timeFrame': 'Baseline, 12 weeks, 36 weeks', 'description': 'Participants complete questions at home using their mobile phone assessing psychological flexibility, mood, eating and diabetes management behavior, for additional data with high ecological validity. The assessment also aims to test the hypothesis that negative mood is decoupled from problem behavior over the course of treatment.'}, {'measure': 'Change in Eating Disorder Examination - Questionnaire (EDE-Q)', 'timeFrame': 'Baseline, 16 weeks, 24 weeks, 36 weeks', 'description': 'Self-report version of the Eating Disorder Examination (EDE). The EDE includes a total score and 4 subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. It is included to capture aspects of ED not assessed by the DEPS, as well as diagnostic outcome or change.'}, {'measure': 'GAD-7', 'timeFrame': 'Baseline, 12 weeks, 36 weeks', 'description': '7-Item assessment of anxiety. The primary purpose for inclusion is as a control variable.'}, {'measure': 'PHQ-9', 'timeFrame': 'Baseline, 12 weeks, 36 weeks', 'description': '9-Item assessment of Depression. The primary purpose for inclusion is as a control variable.'}, {'measure': 'T1DE Questionnaire', 'timeFrame': 'Baseline, End-of-Treatment, 3 Months, 6 Months', 'description': 'This is a 20-item questionnaire developed for the purposes of this trial. The questionnaire is an inventory of target behaviors for individuals with T1DE.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['T1DE', '"diabulimia"', 'glycemic control', 'disordered eating behavior', 'eating disorders', 'type 1 diabetes'], 'conditions': ['Type 1 Diabetes', 'Eating Disorders', 'Disordered Eating Behaviors', 'Purging (Eating Disorders)', 'Binge-Eating Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test the effectiveness of two different approaches to treating problematic eating and weight control in type 1 diabetes. Participants are between the ages of 16-50 and complete 12 sessions of either Acceptance and Commitment Therapy (ACT) or Supportive Diabetes Counseling over 16 weeks. They use their mobile phone between sessions to increase engagement and reinforce learning.\n\nThe main questions are:\n\nDo participants show improvements in glycemic levels, eating disorder symptoms, diabetes management and diabetes distress?\n\nDoes one treatment do better than the other?\n\nHow do the treatments work, if they work, and for whom?\n\nParticipants complete assessments that include wearing a continuous glucose sensor and activity watch, and get a blood draw to determine HbA1c. They also complete diagnostic interviews, surveys and computer tests of attention and reactions. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.', 'detailedDescription': 'This is a randomized controlled trial comparing Acceptance and Commitment Therapy (ACT) to supportive diabetes counseling (SDC) for individuals with type 1 diabetes (T1D) and disordered eating (or T1DE). Both conditions are tailored to the unique needs of individuals living with T1D and the unique conditions under which an eating disorder develops and is maintained. Participants will be 128 individuals with T1D, between the ages of 16-50, with binge-purge eating disorders (EDs), including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Purging includes restriction of insulin for weight loss. An expansion cohort of 58 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=\\>20) will also be recruited to assess the utility of the protocol for a broader array of eating problems in T1D. Participants will be randomized to either ACT or SDC, and complete assessments at baseline, mid-treatment, end-of-treatment, 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is mean blood glucose as assessed by continuous glucose monitoring. Other outcomes include hemoglobin A1c (HbA1c), eating disorder symptoms, diabetes self-management and, secondary, diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Primary Cohort\n\nInclusion Criteria:\n\n* 16-50 years of age\n* Diagnosis of Type 1 diabetes\n* Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)\n* Independently manages diabetes (not reliant on a caregiver)\n\nExpansion Cohort\n\nInclusion Criteria:\n\n* 16-50 years of age\n* Diagnosis of Type 1 diabetes\n* DEPR-R score \\>=20 but does not meet criteria for the primary cohort\n\nPrimary and Expansion Cohort\n\nExclusion Criteria:\n\n* Active suicidal ideation\n* Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses\n* Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years\n* Current substance abuse disorder or current or past psychotic disorder\n* NonEnglish speaking'}, 'identificationModule': {'nctId': 'NCT05540704', 'acronym': 'T1DE', 'briefTitle': 'Study Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling for Problematic Eating and Weight Control in Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Changing the T1DE (Type 1 Disordered Eating): A Randomized Controlled Trial Comparing ACT to Supportive Diabetes Counseling', 'orgStudyIdInfo': {'id': 'Pro00111401'}, 'secondaryIdInfos': [{'id': '4-SRA-2022-1226-M-B', 'type': 'OTHER_GRANT', 'domain': 'Breakthrough T1D (formerly JDRF)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)', 'description': 'ACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits.', 'interventionNames': ['Behavioral: iACT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Supportive Diabetes Counseling (SDC)', 'description': 'The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, diabetes-related psychoeducation and goal setting, based on the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors.', 'interventionNames': ['Other: Supportive Diabetes Counseling']}], 'interventions': [{'name': 'iACT', 'type': 'BEHAVIORAL', 'description': 'Treatment is based on Acceptance and Commitment Therapy (ACT), a contemporary cognitive behavioral therapy (CBT) that improves human functioning and adaptability by increasing psychological flexibility. Individual therapy sessions are paired with mobile phone delivered interventions.', 'armGroupLabels': ['Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)']}, {'name': 'Supportive Diabetes Counseling', 'type': 'OTHER', 'description': '12 sessions of counseling with a diabetes educator knowledgeable about disordered eating in type 1 diabetes. Intervention focuses on supportive listening, diabetes-related education and goal setting.', 'armGroupLabels': ['Supportive Diabetes Counseling (SDC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dottie R Mayo, BA', 'role': 'CONTACT', 'email': 'dorothy.mayo@duke.edu', 'phone': '919-668-1935'}, {'name': 'Rhonda M Merwin, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erica F Robichaud, LCSW', 'role': 'CONTACT', 'email': 'eferguson@lifespan.org', 'phone': '401-793-8957'}, {'name': 'Jason Lillis, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Brown University', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'centralContacts': [{'name': 'Dottie R Mayo, BA', 'role': 'CONTACT', 'email': 'drm72@duke.edu', 'phone': '(919) 668-1935'}, {'name': 'Rhonda Merwin, PhD', 'role': 'CONTACT', 'email': 'rhonda.merwin@duke.edu', 'phone': '(919) 681-7231'}], 'overallOfficials': [{'name': 'Rhonda Merwin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Miriam Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}