Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes (NCT05540704)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Duke University — Durham, North Carolina
Age range: 16 Years to 50 Years
🧪 Interventions in This Study
- ACT (BEHAVIORAL)
- Supportive Diabetes Counseling (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Duke University — Durham, North Carolina
- Brown University — Providence, Rhode Island
📞 Contact the Study Coordinator
Phone: (919) 668-1935
Email: drm72@duke.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes
- A 12-week Pilot Nutrition Intervention for Children With New Diagnosis of Stage 3 Type 1 Diabetes (T1D) — Hershey, Pennsylvania
- Remedy to Diabetes Distress (R2D2): A Scalable Screen to Treat Program for School-age Families — Jacksonville, Florida
- Diabetes Inspired Culinary Education (DICE): Culinary Medicine Intervention for At-Risk Youth With Type 1 Diabetes — Cleveland, Ohio
- GO TEAM: Glucose Optimization Through Technology Assisted Management — Cleveland, Ohio
- REAL-Fam Feasibility Study for Youth Diabetes Management — Chapel Hill, North Carolina
- Reducing Diabetes Distress Using Cognitive Behavioral Therapy in Young Adults With Type 1 Diabetes — New York, New York
Explore by condition: All Type 1 Diabetes clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.