iACT for Eating Disorders in Type 1 Diabetes

Study Overview
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Brief Summary
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This project is a randomized controlled trial of iACT, a novel mHealth intervention for eating disorders in type 1 diabetes (ED-T1DM). Participants will be 128 T1DM patients between the ages of 16-45 with binge-purge EDs, including threshold and subthreshold bulimia nervosa, binge eating disorder and purging disorder. Participants will be randomized to either iACT or Usual Care, and complete assessments at baseline and every 3 months for 9 months. The primary outcome of interest is glycemic control as assessed by continuous glucose monitoring. Other outcomes include HbA1c, eating disorder symptoms, diabetes self-management and 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.

Official Title
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A Randomized Controlled Trial of iACT, a Novel mHealth Intervention for Eating Disorders in Type 1 Diabetes

Conditions
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Type 1 Diabetes, Eating Disorders

Intervention / Treatment
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* Behavioral: iACT
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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) Exclusion Criteria: Current suicidal ideation or self-harming behavior Diagnosis of Avoidant Restrictive Food Intake Disorder or Anorexia Nervosa spectrum diagnoses Hypoglycemic unawareness as assessed by the Gold Method Current substance abuse disorder or current or past psychotic disorder NonEnglish speaking

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iACT Experimental Intervention<br> | Behavioral: iACT<br>* 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.<br>|
| Active Comparator: Usual Care<br> | Other: Usual Care<br>* Usual care for problems in Type 1 diabetes management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic control as indexed by continuous glucose monitoring (CGM) | CGM indices of time in range, frequency of Level 1 and 2 hyperglycemia and blood glucose variability | baseline, 6 weeks, 12 weeks, 36 weeks | 
| Change in glycemic control as indexed by hemoglobin A1c (HbA1c) | Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months) | baseline, 12 weeks, 24 weeks, 36 weeks | 
| Change in eating disorder symptoms as indexed by the Eating Disorder Examination Global score | Severity of eating and body image concerns, frequency of engagement in maladaptive eating and weight control behaviors. Global scores range from 0-6, with higher scores indicating greater symptom severity (worse outcome). | baseline, 12 weeks, 36 weeks | 
| Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey | 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). | baseline, 12 weeks, 24 weeks, 36 weeks | 
| Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire | 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. | baseline, 12 weeks, 24 weeks, 36 weeks | 
| Acceptability as measured by meeting the recruitment target for the study | recruitment of n=128 | 36 months from start of enrollment | 
| Feasibility as measured by participant attrition less than 20% | Less than n=26 individuals dropping out of treatment prematurely | 39 months from start of enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale | 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) | baseline, 12 weeks, 24 weeks, 36 weeks | 
| Change in NIH PROMIS Scale - Depression | 8 items assessing depressive affect, scored 1-5 and t-score normed (mean of 50, standard deviation of 10). Higher scores indicating greater symptoms (worse outcome). | baseline, 12 weeks, 36 weeks | 
| Change in NIH PROMIS Scale - Anxiety | 8 items assessing anxious affect, scored 1-5 and t-score normed (mean of 50, standard deviation of 10). Higher scores indicating greater symptoms (worse outcome). | baseline, 12 weeks, 36 weeks |