Actively Recruiting
Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
Led by Duke University · Updated on 2026-02-25
235
Participants Needed
2
Research Sites
230 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
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.
CONDITIONS
Official 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...
- Aged 16 to 50 years
- Diagnosis of type 1 diabetes
- Eating disorder with binge eating and/or problematic weight control behaviors, including insulin withholding (Bulimia Nervosa, Binge Eating, or Purging Disorder)
- Independently manages diabetes without caregiver support
- For expansion cohort: DEPS-R score of 20 or higher without meeting primary cohort criteria
You will not qualify if you...
- Active suicidal ideation
- Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum
- Hypoglycemic unawareness or multiple severe hypoglycemia episodes needing third-party help in the past 2 years
- Current substance abuse disorder or current/past psychotic disorder
- Non-English speaking
AI-Screening
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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
CONTACT
R
Rhonda Merwin, PhD
CONTACT
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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