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RECRUITING Not applicable ClinicalTrials.gov

Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes

Sponsor: Duke University • ClinicalTrials.gov ID: NCT05540704

Registry updated: 2026-09-08
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Description

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.

Interventions

  • ACT (Behavioral)
    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.
  • Supportive Diabetes Counseling (Behavioral)
    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.

Eligibility criteria

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

Conditions

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

Locations

  • Duke University — Durham, North Carolina, United States
  • Brown University — Providence, Rhode Island, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record