NCT Number: NCT05540704
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.
Interested in participating?
Request Info16 year–50 year
All sexes
Interventional
Not applicable
Duke University, Durham, North Carolina, United States
This is a randomized controlled trial comparing an Acceptance and Commitment Therapy (ACT) protocol to supportive diabetes counseling (SDC) and a Waitlist Control (WLC) for individuals with type 1 diabetes and disordered eating (or T1DE). Both active conditions are tailored to the needs of individuals living with T1D and the unique conditions under which the eating disorder developed and is maintained. Participants will be 161 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 74 persons with T1D and elevated Diabetes Eating Problems Survey-Revised scores (DEPS-R=>20) will also be recruited to assess the utility of the treatments for a broader array of eating and weight control problems in T1D. Participants will be randomized to either ACT, SDC, or a WLC and complete assessments at baseline, mid-treatment, end-of-treatment, and at 1 month, 3 months, and 6 months post-treatment. The primary outcome of interest for power and sample size calculation is blood glucose levels (mean and % time in target glycemic range) as assessed by continuous glucose monitoring. Other outcomes include change in 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Primary Cohort
Inclusion criteria
Expansion Cohort
Inclusion criteria
Primary and Expansion Cohort
Exclusion criteria
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.
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.
Time frame: baseline, 6 weeks, 12 weeks, 36 weeks
CGM indices of time in target glycemic range, mean blood sugar, frequency of Level 1 and 2 hyperglycemia and blood glucose variability
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks
Assesses psychological flexibility (process of change) in the context of diabetes specific thoughts and feelings.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks, 36 weeks
Assesses physiological flexibility/adaptability in the presence of emotional stimuli as an exploratory process of change measure.
Time frame: Baseline, 12 weeks, 36 weeks
Measures sleep and physical activity as exploratory measures of behavioral mechanisms of change.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12 weeks, 36 weeks
7-Item assessment of anxiety. The primary purpose for inclusion is as a control variable.
Time frame: Baseline, 12 weeks, 36 weeks
9-Item assessment of Depression. The primary purpose for inclusion is as a control variable.
Time frame: 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.
Time frame: Mid-treatment
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.
Contact information is provided by the study sponsor or research team.
Dottie R Mayo, BA
CONTACT
Rhonda Merwin, PhD
CONTACT
Duke University
Other
Changing the T1DE (Type 1 Diabetes Eating Disorders): A Randomized Controlled Trial Comparing Acceptance and Commitment Therapy (ACT) to Supportive Diabetes Counseling and a Waitlist Control
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