Actively Recruiting

Phase Not Applicable
Age: 16Years - 50Years
All Genders
NCT05540704

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

Led by Duke University · Updated on 2026-02-25

235

Participants Needed

2

Research Sites

230 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

T

The Miriam Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 16 to 50 years
  • Diagnosis of type 1 diabetes
  • Eating disorder with binge eating and/or problematic weight control behaviors, including insulin withholding (Bulimia Nervosa, Binge Eating, or Purging Disorder)
  • Independently manages diabetes without caregiver support
  • For expansion cohort: DEPS-R score of 20 or higher without meeting primary cohort criteria
Not Eligible

You will not qualify if you...

  • Active suicidal ideation
  • Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum
  • Hypoglycemic unawareness or multiple severe hypoglycemia episodes needing third-party help in the past 2 years
  • Current substance abuse disorder or current/past psychotic disorder
  • Non-English speaking

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Duke University

Durham, North Carolina, United States, 27705

Actively Recruiting

2

Brown University

Providence, Rhode Island, United States, 02903

Actively Recruiting

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Research Team

D

Dottie R Mayo, BA

CONTACT

R

Rhonda Merwin, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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