Study Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling for Problematic Eating and Weight Control in Type 1 Diabetes (T1DE)

Duke University

Status: Enrolling

Conditions: Binge-Eating Disorder; Type 1 Diabetes; Disordered Eating Behaviors; Eating Disorders; Purging (Eating Disorders)

Treatments: Behavioral: iACT; Other: Supportive Diabetes Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT05540704

4-SRA-2022-1226-M-B (Other Grant/Funding Number)

Pro00111401

Details and patient eligibility

About

The goal of this study is to test the effectiveness of two different approaches to treating problematic eating and weight control in type 1 diabetes. Participants are between the ages of 16-50 and complete 12 sessions of either Acceptance and Commitment Therapy (ACT) or Supportive Diabetes Counseling over 16 weeks. They use their mobile phone between sessions to increase engagement and reinforce learning.

The main questions are:

Do participants show improvements in 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 reactions. These assessments help us better understand the types of changes that are happening and how they might influence health and well-being.

Full description

This is a randomized controlled trial comparing Acceptance and Commitment Therapy (ACT) to supportive diabetes counseling (SDC) for individuals with type 1 diabetes (T1D) and disordered eating (or T1DE). Both conditions are tailored to the unique needs of individuals living with T1D and the unique conditions under which an eating disorder develops and is maintained. Participants will be 128 individuals with T1D, between the ages of 16-50, with binge-purge eating disorders (EDs), including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Purging includes restriction of insulin for weight loss. An expansion cohort of 58 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=>20) will also be recruited to assess the utility of the protocol for a broader array of eating problems in T1D. Participants will be randomized to either ACT or SDC, and complete assessments at baseline, mid-treatment, end-of-treatment, 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is mean blood glucose as assessed by continuous glucose monitoring. Other outcomes include hemoglobin A1c (HbA1c), eating disorder symptoms, diabetes self-management and, secondary, diabetes distress. In addition to examining clinical outcomes, this study tests biobehavioral mechanisms of change and predictors of treatment response. Process of change assessments focus on flexible responding to pathology-relevant stimuli and early improvement in glycemic control affecting executive function. The primary site is Duke University Medical Center. The Miriam Hospital is a secondary site.

Enrollment: 180 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Acceptance and Commitment Therapy for Type 1 Diabetes - Eating Disorder (ACT-T1DE)

Experimental group

Description:

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.

Treatment:

Behavioral: iACT

Supportive Diabetes Counseling (SDC)

Active Comparator group

Description:

The SDC condition is a flexible protocol of 12 sessions consisting of supportive listening, diabetes-related psychoeducation and goal setting, based on the ADA Type 1 Diabetes Self-Care Manual and ADCES7 Self-Care Behaviors.

Treatment:

Other: Supportive Diabetes Counseling