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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

RECRUITINGN/ASponsored by Duke University
Actively Recruiting
PhaseN/A
SponsorDuke University
Started2023-04-04
Est. completion2027-06
Eligibility
Age16 Years – 50 Years
Healthy vol.Accepted
Locations2 sites

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

Age: 16 Years – 50 YearsHealthy volunteers accepted
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

Conditions6

Binge-Eating DisorderDiabetesDisordered Eating BehaviorsEating DisordersPurging (Eating Disorders)Type 1 Diabetes

Locations2 sites

North Carolina

1 site
Duke University
Durham, North Carolina, 27705
Dottie R Mayo, BA919-668-1935dorothy.mayo@duke.edu

Rhode Island

1 site
Brown University
Providence, Rhode Island, 02903
Erica F Robichaud, LCSW(401) 793-8957eferguson@lifespan.org

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