Actively Recruiting
Changing the T1DE: A Randomized Trial Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and Waitlist Control for Eating Disorders in Type 1 Diabetes
Led by Duke University · Updated on 2026-02-25
235
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
T
The Miriam Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for eating disorders in people with type 1 diabetes through a randomized controlled trial. This study compares Acceptance and Commitment Therapy (ACT) with Supportive Diabetes Counseling and a 6-month Waitlist Control. It aims to see if these treatments improve blood sugar control, eating disorder symptoms, diabetes management, and diabetes-related distress, while also exploring how and for whom the treatments work. Participants receive one of three options: the ACT program with 12 therapy sessions tailored to type 1 diabetes eating disorders using a mix of in-person and virtual visits plus supportive text messaging; Supportive Diabetes Counseling consisting of 12 sessions focused on listening, diabetes education, and goal setting; or placement on a waitlist without treatment. Both active treatments are delivered over 12 to 16 weeks and include phone-based support between sessions to boost engagement. During the study, participants undergo regular assessments including continuous glucose monitoring, blood tests for HbA1c, diagnostic interviews, surveys, and tests measuring attention, heart rate, and reaction time. Evaluations occur at baseline, mid-treatment, end-of-treatment, and at 1, 3, and 6 months after treatment ends. These measures help researchers understand treatment effects on health and behavior. The total participation lasts several months with follow-up to track lasting changes and safety.
CONDITIONS
Brief Title
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 50 years
- Diagnosis of Type 1 diabetes
- Eating disorder involving binge eating and/or problematic weight control behaviors such as withholding insulin (including Bulimia Nervosa, Binge Eating Disorder, and Purging Disorder)
- Ability to manage diabetes independently without caregiver assistance
- For expansion cohort: DEPS-R score of 20 or higher but not meeting primary cohort criteria
You will not qualify if you...
- Active suicidal ideation
- Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum disorders
- Hypoglycemic unawareness with multiple severe episodes requiring third-party help in the past 2 years
- Current substance abuse disorder or current or past psychotic disorder
- Non-English speaking
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 12 weeks
Participants receive 12 sessions of either Acceptance and Commitment Therapy (ACT) or Supportive Diabetes Counseling (SDC), tailored to individuals with type 1 diabetes and disordered eating. Sessions combine in-person and virtual visits and include mobile phone delivered interventions or supportive counseling.
12 therapy sessions (combination of in-person and virtual visits)
Duration - 6 months
Participants complete follow-up assessments to monitor changes in glycemic control, eating disorder symptoms, diabetes self-management, and other health outcomes up to 6 months after treatment ends.
Assessments at 1 month, 3 months, and 6 months post-treatment
Trial Site Locations
Total: 2 locations
1
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
2
Brown University
Providence, Rhode Island, United States, 02903
Actively Recruiting
Research Team
D
Dottie R Mayo, BA
R
Rhonda Merwin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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