Study Comparing Acceptance and Commitment Therapy to Supportive Diabetes Counseling and a Waitlist Control for Eating Disorders in Type 1 Diabetes

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое ACT
  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.
• Поведенческое Supportive Diabetes Counseling
  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.

Первичные конечные точки

• Change in glycemic control as indexed by continuous glucose monitoring (CGM) [Срок оценки: baseline, 6 weeks, 12 weeks, 36 weeks]
• Change in eating disorder symptoms as indexed by the Diabetes Eating Problems Survey-Revised (DEPS-R) [Срок оценки: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks]
• Change in diabetes self-management as indexed by the Diabetes Self-Management Questionnaire [Срок оценки: baseline, 12 weeks, 16 weeks, 24 weeks, 36 weeks]
• Change in glycemic control as indexed by hemoglobin A1c (HbA1c) [Срок оценки: baseline, 24 weeks, 36 weeks]

Вторичные конечные точки (12)

• Change in diabetes distress as indexed by the Type 1 - Diabetes Distress Scale [Срок оценки: baseline, 12 weeks, 24 weeks, 36 weeks]
• CompACT-10 [Срок оценки: Baseline, Mid-Treatment, 12 weeks, 16 weeks, 24 weeks, 36 weeks.]
• Acceptance and Action Diabetes Questionnaire (AADQ) [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks]
• Valuing Questionnaire (VQ) [Срок оценки: Baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks]
• Executive function [Срок оценки: Baseline, 12 weeks, 36 weeks]
• High Frequency Heart Rate Variability (HF-HRV) [Срок оценки: Baseline, 12 weeks, 36 weeks]
• Actigraphy [Срок оценки: Baseline, 12 weeks, 36 weeks]
• Ecological Momentary Assessment (EMA) [Срок оценки: Baseline, 12 weeks, 36 weeks]
• Change in Eating Disorder Examination - Questionnaire (EDE-Q) [Срок оценки: Baseline, 16 weeks, 24 weeks, 36 weeks]
• GAD-7 [Срок оценки: Baseline, 12 weeks, 36 weeks]
• PHQ-9 [Срок оценки: Baseline, 12 weeks, 36 weeks]
• T1DE Questionnaire [Срок оценки: Baseline, End-of-Treatment, 3 Months, 6 Months]

Критерии участия

Primary Cohort

Критерии включения

• 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

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Duke University — Durham
• Brown University — Providence

Идентификаторы

NCT: NCT05540704 · Pro00111401 · 4-SRA-2022-1226-M-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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