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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

RecruitingNAAges 16 Years - 50 YearsAllDuke University
NCT05540704 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • ACT
  • Supportive Diabetes Counseling
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Where

2 sites
Duke University
Durham, United States
Brown University
Providence, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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