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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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws, Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "An expansion cohort of 74 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=\>20) will also be recruited to assess the utility of the treatments for a broader array of eating and weight control problems in T1D."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Acceptance and Commitment Therapy (ACT) for eating problems in people ages 16–50 with type 1 diabetes. It compares ACT with supportive diabetes counseling and a 6-month waiting group to see how they affect blood sugar, eating problems, diabetes care, and stress. Both treatment groups have 12 sessions over 12–16 weeks and use a mobile phone between sessions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both groups: Ages 16–50.
  • Both groups: Have type 1 diabetes.
  • Main group: Have an eating disorder with binge eating (eating large amounts) or harmful ways to control weight, such as skipping insulin.
  • Main group: Manage diabetes on your own, without relying on a caregiver.
  • Added group: Have a DEPR-R screening score of 20 or higher but do not meet the main group's rules.

Who can't join

  • Currently have thoughts of suicide.
  • Have anorexia or a related disorder, or avoidant restrictive food intake disorder (avoiding or limiting food).
  • Have trouble noticing low blood sugar, based on the Gold Method test, AND have had several severe low blood sugar events needing someone else's help in the past 2 years.
  • Currently have a substance abuse disorder.
  • Have or have ever had a psychotic disorder, which can make it hard to tell what is real.
  • Do not speak English.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

NC

RI