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.
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)
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
Parallel
ACT
BehavioralTreatment 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
BehavioralCounseling 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.
Change in glycemic control as indexed by continuous glucose monitoring (CGM)
CGM indices of time in target glycemic range, mean blood sugar, 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)
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
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)
Glycated hemoglobin (percentage of red blood cells that are glycated providing an estimate of average blood glucose over 3 months)
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)
CompACT-10
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)
Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.
Valuing Questionnaire (VQ)
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.
Working Alliance Inventory - Short Revised
This is a 13-item self-report questionnaire that measures experiences individuals have with their therapy or therapist. It includes three subscale scores: goal items, task items, and bond items. It is included as a potential moderator of treatment effects.
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