Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlis… (NCT05540704) | Clinical Trial Compass
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Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes
United States235 participantsStarted 2023-04-04
Plain-language 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.
Who can participate
Age range
16 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
Timeframe: baseline, 6 weeks, 12 weeks, 36 weeks
2
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)