Recruiting

iACT

Sponsor:

Duke University

Code:

NCT05540704

Conditions

Type 1 Diabetes

Eating Disorders

Disordered Eating Behaviors

Purging (Eating Disorders)

Binge-Eating Disorder

Eligibility Criteria

Sex: All

Age: 16 - 50

Healthy Volunteers: Not accepted

Interventions

ACT

Supportive Diabetes Counseling

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Eating Disorders

Disordered Eating Behaviors

Purging (Eating Disorders)

Binge-Eating Disorder

Study ID

NCT05540704

Start date

Apr 4, 2023

Status verified date

Sep, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 50

Healthy Volunteers: Not 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

Study Design

Enrollment

235 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ACT

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

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.

Primary outcome measure

  • Change in glycemic control as indexed by continuous glucose monitoring (CGM) [ Time Frame: baseline, 6 weeks, 12 weeks, 36 weeks ]
  • Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R) [ Time Frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks ]
  • Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire [ Time Frame: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks ]
  • Change in glycemic control as indexed by hemoglobin A1c (HbA1c) [ Time Frame: baseline, 24 weeks, 36 weeks ]

Central Contacts and Locations

Central contacts

Dottie R Mayo, BA

(919) 668-1935drm72@duke.edu

Rhonda Merwin, PhD

(919) 681-7231rhonda.merwin@duke.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Dottie R Mayo, BA

919-668-1935dorothy.mayo@duke.edu

Principal Investigator:

Rhonda M Merwin, Ph.D.

Brown University

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Erica F Robichaud, LCSW

(401) 793-8957eferguson@lifespan.org

Principal Investigator:

Jason Lillis, Ph.D.

More Information

Sponsor

Duke University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • glycemic control
  • disordered eating behavior
  • eating disorders
  • type 1 diabetes
  • acceptance and commitment therapy
  • diabetes counseling
  • mhealth
  • psychological flexibility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-09-08.