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

Not Applicable

Recruiting

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

• Registration Number: NCT05540704
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-09-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-15
• Study Start: 2023-04-04
• Status Verified: 2025-09
• Last Update Submitted: 2025-10-17
• Last Update Posted: 2025-10-21
• Primary Completion: 2027-06
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in glycemic control as indexed by continuous glucose monitoring (CGM)	baseline, 6 weeks, 12 weeks, 36 weeks	CGM indices of time in range, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R)	baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks	Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors, specifically in the context of diabetes. Scores range from 0-80, with higher scores indicating greater symptom severity (worse outcome).
Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire	baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks	Engagement in activities necessary to manage diabetes, including checking blood sugar and administering insulin. Scores range from 0-10 with higher scores indicating better self-management.
Change in glycemic control as indexed by hemoglobin A1c (HbA1c)	baseline, 24 weeks, 36 weeks	Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)

Secondary Outcome Measures

Name	Time	Method
Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale	baseline, 12 weeks, 24 weeks, 36 weeks	Feelings of stress or overwhelm with the burden of living with diabetes and diabetes management. Scores range from 1-6, with higher scores indicating greater distress (worse outcome)
CompACT-10	Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.	A 10-item measure of general (rather than diabetes-specific) psychological flexibility. This measure includes component processes of open, aware and engaged, allowing for more in-depth assessment of process of change. This is the primary psychological flexibility measure in the current trial.
Acceptance and Action Diabetes Questionnaire (AADQ)	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks	Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.
Valuing Questionnaire (VQ)	Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks	Assesses outcomes expected in an ACT intervention. The VQ consists of 2 Subscales: Values Obstruction and Values Progress. Values Obstruction measures the extent to which thoughts/feelings obstructed engagement in values. Values Progress measures the extent to which an individual made progress in areas of life that are important to them.
Executive function	Baseline, 12 weeks, 36 weeks	Computer-administered Stroop and a GoNoGo paradigm. Outcomes of interest are interference or bias score and errors and reaction time (respectively). These measures are included to test the hypothesis that executive function is improved with the improvement of eating disorder symptoms and glycemic control.
High Frequency Heart Rate Variability (HF-HRV)	Baseline, 12 weeks, 36 weeks	Assesses physiological flexibility/adaptability in the presence of emotional stimuli as an exploratory process of change measure.
Actigraphy	Baseline, 12 weeks, 36 weeks	Measures sleep and physical activity as exploratory measures of behavioral mechanisms of change.
Ecological Momentary Assessment (EMA)	Baseline, 12 weeks, 36 weeks	Participants complete questions at home using their mobile phone assessing psychological flexibility, mood, eating and diabetes management behavior, for additional data with high ecological validity. The assessment also aims to test the hypothesis that negative mood is decoupled from problem behavior over the course of treatment.
Change in Eating Disorder Examination - Questionnaire (EDE-Q)	Baseline, 16 weeks, 24 weeks, 36 weeks	Self-report version of the Eating Disorder Examination (EDE). The EDE includes a total score and 4 subscale scores: Restraint, Eating Concerns, Weight Concerns, Shape Concerns. It is included to capture aspects of ED not assessed by the DEPS, as well as diagnostic outcome or change.
GAD-7	Baseline, 12 weeks, 36 weeks	7-Item assessment of anxiety. The primary purpose for inclusion is as a control variable.
PHQ-9	Baseline, 12 weeks, 36 weeks	9-Item assessment of Depression. The primary purpose for inclusion is as a control variable.
T1DE Questionnaire	Baseline, End-of-Treatment, 3 Months, 6 Months	This is a 20-item questionnaire developed for the purposes of this trial. The questionnaire is an inventory of target behaviors for individuals with T1DE.

Trial Locations

Locations (2)

Duke University; 🇺🇸 Durham, North Carolina, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States