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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05540704
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
16 Years - 50 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Apr 4, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
235 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)
    ACT-T1DE consists of 12 sessions of flexible ACT protocol tailored to the unique conditions and needs of type 1 diabetes eating disorders. The protocol is based on an initial pilot study (Merwin et al., 2021); however, the current protocol has been modified, based on key stakeholder feedback and to optimize real-world implementation. Modifications include transition from the use of a mobile app to a text messaging platform and a combination of in-person and virtual visits.
  • Active Comparator: Supportive Diabetes Counseling (SDC)
    The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, psychoeducation about diabetes and its management and management problems, and goal setting, informed by the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors framework.
  • No Intervention: 6-Month Waitlist Control
    Participants assigned to the Waitlist Control complete assessments but do not receive intervention.

Primary Outcome Measure

Change in glycemic control as indexed by continuous glucose monitoring (CGM) [ Time Frame: baseline, 6 weeks, 12 weeks, 36 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27705
Dottie R Mayo, BA
[email protected]
919-668-1935
Rhonda M Merwin, Ph.D. (PRINCIPAL_INVESTIGATOR)
Brown UniversityProvidenceRhode Island02903
Erica F Robichaud, LCSW
[email protected]
(401) 793-8957
Jason Lillis, Ph.D. (PRINCIPAL_INVESTIGATOR)

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By specialty
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