RecruitingNot ApplicableNCT05540704

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

Sponsor

Duke University

Enrollment

235 participants

Start Date

Apr 4, 2023

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Eating Disorders Binge-Eating Disorder Disordered Eating Behaviors Purging (Eating Disorders)

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.

Eligibility

Min Age: 16 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing Acceptance and Commitment Therapy (ACT — a type of talk therapy that helps people change their relationship with difficult thoughts and emotions) to supportive diabetes counseling for people with Type 1 diabetes who have an eating disorder. Many people with Type 1 diabetes engage in dangerous behaviors like skipping insulin to lose weight, and this study seeks to find the best psychological treatment for them. **You may be eligible if:** - You are 16–50 years old - You have Type 1 diabetes - You have an eating disorder involving binge eating, purging, or deliberately skipping insulin - You manage your own diabetes independently **You may NOT be eligible if:** - You have active suicidal thoughts - You have anorexia nervosa or avoidant/restrictive food intake disorder - You frequently experience severe low blood sugar episodes requiring help from others - You are pregnant or nursing - You are taking insulin-sensitizing or weight-loss medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALACT

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.

BEHAVIORALSupportive 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.