Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control
2 other identifiers
interventional
235
1 country
2
Brief Summary
The goal of this clinical trial is to test whether a new intervention works to treat eating disorders in type 1 diabetes. Participants are assigned to one of the following: (1) Acceptance and Commitment Therapy (ACT), (2) Supportive Diabetes Counseling, or (3) a 6-month Waitlist Control. Participants in the ACT and Supportive Diabetes Counseling conditions complete 12 sessions over 12-16 weeks and use their mobile phone between sessions to increase engagement and reinforce learning. The main questions are: Does treatment improve glycemic levels, eating disorder symptoms, diabetes management and diabetes distress? Does one treatment do better than the other? How do the treatments work, if they work, and for whom? Participants 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 things like heart rate and reaction time. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2022
CompletedFirst Posted
Study publicly available on registry
September 15, 2022
CompletedStudy Start
First participant enrolled
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 25, 2026
September 1, 2025
4.2 years
September 9, 2022
February 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
CGM indices of time in target glycemic range, mean blood sugar, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
baseline, 6 weeks, 12 weeks, 36 weeks
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)
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).
baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire
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.
baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)
Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)
baseline, 24 weeks, 36 weeks
Secondary Outcomes (12)
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
baseline, 12 weeks, 24 weeks, 36 weeks
CompACT-10
Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.
Acceptance and Action Diabetes Questionnaire (AADQ)
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Valuing Questionnaire (VQ)
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Executive function
Baseline, 12 weeks, 36 weeks
- +7 more secondary outcomes
Other Outcomes (1)
Working Alliance Inventory - Short Revised
Mid-treatment
Study Arms (3)
Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)
EXPERIMENTALACT-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.
Supportive Diabetes Counseling (SDC)
ACTIVE COMPARATORThe SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, psychoeducation about diabetes and its management and management problems, and goal setting, informed by the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors framework.
6-Month Waitlist Control
NO INTERVENTIONParticipants assigned to the Waitlist Control complete assessments but do not receive intervention.
Interventions
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.
Counseling with a diabetes educator knowledgeable about disordered eating in type 1 diabetes. Intervention focuses on supportive listening, diabetes-related education, including management problems and goal setting.
Eligibility Criteria
You may qualify if:
- years of age
- Diagnosis of Type 1 diabetes
- Eating disorder characterized by binge eating and/or problematic weight control behaviors, including withholding insulin (Bulimia Nervosa, Binge Eating and Purging Disorder spectrum diagnoses)
- Independently manages diabetes (not reliant on a caregiver)
- Expansion Cohort
- years of age
- Diagnosis of Type 1 diabetes
- DEPR-R score \>=20 but does not meet criteria for the primary cohort
- Primary and Expansion Cohort
You may not qualify if:
- Active suicidal ideation
- Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses
- Hypoglycemic unawareness as assessed by the Gold Method and multiple severe episodes of hypoglycemia requiring 3rd party assistance in the last 2 years
- Current substance abuse disorder or current or past psychotic disorder
- NonEnglish speaking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Miriam Hospitalcollaborator
- Duke Universitylead
- Breakthrough T1Dcollaborator
Study Sites (2)
Duke University
Durham, North Carolina, 27705, United States
Brown University
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rhonda Merwin, PhD
Duke University faculty
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Assessors are blinded to the participant's assignment/condition. All study team members are blinded to the randomization schedule.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2022
First Posted
September 15, 2022
Study Start
April 4, 2023
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 25, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share