Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes (T1DE)

February 23, 2026 updated by: Duke University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized controlled trial comparing an Acceptance and Commitment Therapy (ACT) protocol to supportive diabetes counseling (SDC) and a Waitlist Control (WLC) for individuals with type 1 diabetes and disordered eating (or T1DE). Both active conditions are tailored to the needs of individuals living with T1D and the unique conditions under which the eating disorder developed and is maintained. Participants will be 161 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 74 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=>20) will also be recruited to assess the utility of the treatments for a broader array of eating and weight control problems in T1D. Participants will be randomized to either ACT, SDC, or a WLC and complete assessments at baseline, mid-treatment, end-of-treatment, and at 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is blood glucose levels (mean and % time in target glycemic range) as assessed by continuous glucose monitoring. Other outcomes include change in 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.

Study Type

Interventional

Enrollment (Estimated)

235

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dottie R Mayo, BA
  • Phone Number: (919) 668-1935
  • Email: drm72@duke.edu

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • Rhonda M Merwin, Ph.D.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Brown University
        • Principal Investigator:
          • Jason Lillis, Ph.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Primary Cohort

Inclusion Criteria:

  • 16-50 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

Inclusion Criteria:

  • 16-50 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)
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.
Behavioral: ACT
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.
Active Comparator: Supportive Diabetes Counseling (SDC)
The 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.
Behavioral: Supportive Diabetes Counseling
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.
No Intervention: 6-Month Waitlist Control
Participants assigned to the Waitlist Control complete assessments but do not receive intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)
Time Frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
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
Time Frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks
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)
Time Frame: baseline, 24 weeks, 36 weeks
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
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
Time Frame: baseline, 6 weeks, 12 weeks, 36 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale
Time Frame: baseline, 12 weeks, 24 weeks, 36 weeks
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)
baseline, 12 weeks, 24 weeks, 36 weeks
CompACT-10
Time Frame: Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.
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.
Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.
Acceptance and Action Diabetes Questionnaire (AADQ)
Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Valuing Questionnaire (VQ)
Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
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.
Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Executive function
Time Frame: Baseline, 12 weeks, 36 weeks
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.
Baseline, 12 weeks, 36 weeks
High Frequency Heart Rate Variability (HF-HRV)
Time Frame: Baseline, 12 weeks, 36 weeks
Assesses physiological flexibility/adaptability in the presence of emotional stimuli as an exploratory process of change measure.
Baseline, 12 weeks, 36 weeks
Actigraphy
Time Frame: Baseline, 12 weeks, 36 weeks
Measures sleep and physical activity as exploratory measures of behavioral mechanisms of change.
Baseline, 12 weeks, 36 weeks
Ecological Momentary Assessment (EMA)
Time Frame: Baseline, 12 weeks, 36 weeks
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.
Baseline, 12 weeks, 36 weeks
Change in Eating Disorder Examination - Questionnaire (EDE-Q)
Time Frame: Baseline, 16 weeks, 24 weeks, 36 weeks
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.
Baseline, 16 weeks, 24 weeks, 36 weeks
GAD-7
Time Frame: Baseline, 12 weeks, 36 weeks
7-Item assessment of anxiety. The primary purpose for inclusion is as a control variable.
Baseline, 12 weeks, 36 weeks
PHQ-9
Time Frame: Baseline, 12 weeks, 36 weeks
9-Item assessment of Depression. The primary purpose for inclusion is as a control variable.
Baseline, 12 weeks, 36 weeks
T1DE Questionnaire
Time Frame: Baseline, End-of-Treatment, 3 Months, 6 Months
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.
Baseline, End-of-Treatment, 3 Months, 6 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Working Alliance Inventory - Short Revised
Time Frame: Mid-treatment
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.
Mid-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

The Miriam Hospital
Breakthrough T1D

Investigators

  • Principal Investigator: Rhonda Merwin, PhD, Duke University faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2023

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 9, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00111401
  • 4-SRA-2022-1226-M-B (Other Grant/Funding Number: Breakthrough T1D (formerly JDRF))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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