Weight Loss Treatment and CBT for Veterans With Binge Eating
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Change in Binge Episodes From Eating Disorder Examination Interview
研究概览
简要总结
This study aims to adapt and test a cognitive behavioral therapy (CBT) treatment that can be administered concurrently with the Veteran's Health Administration (VHA) MOVE! weight management program for Veterans with DSM-5 Binge Eating Disorder (BED) and high weight.
详细描述
To date, there have been limited studies of Binge Eating Disorder (BED) and high weight utilizing combined eating disorder and weight management approaches in real-world settings, nor studies with complex and diverse samples. The objective of this project was to conduct a clinical trial that would produce evidence-based findings for a diverse patient group in a healthcare setting. Specifically, we aimed to address comorbid BED and high weight among Veterans in the Veteran's Health Administration (VHA), the largest integrated healthcare system in the U.S., by testing the effectiveness of VA's evidence-based weight management program, called MOVE!, versus MOVE! administered concurrent with a brief, clinician-led cognitive-behavioral therapy (CBT).
Aim 1: To assess the effectiveness of MOVE! (treatment-as-usual) to MOVE! plus brief, clinician-led CBT (MOVE!+CBT).
Hypothesis 1: It is hypothesized that MOVE!+CBT will have greater improvements on the primary outcomes of eating pathology and binge eating (reductions in binge frequency and percentage of participants who are binge remitted) than MOVE! alone.
Hypothesis 2: It is further hypothesized that MOVE!+CBT will have greater improvements on secondary measures of mental health, quality of life, and other eating behaviors.
Aim 2: To conduct exploratory analyses assessing the effectiveness of MOVE! to MOVE! vs. MOVE!+CBT on weight outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
Treating therapists will be blind to outcome data
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of recurrent binge eating on the MOVE! Survey
排除标准
- •More than 4 MOVE! sessions in the prior year
- •Active psychosis or suicidal ideation
- •Medical or psychiatric illness, or cognitive deficits that interfere with providing consent or completing assessments
- •Pregnancy or lactation
结局指标
主要结局
Change in Binge Episodes From Eating Disorder Examination Interview
时间窗: Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EDE is a clinician administered interview that is considered to be the gold standard for diagnosing eating disorders and assessing binge frequency. Number of binges; higher=worse
Change in Eating Disorder Examination-Self-report Questionnaire (EDE-Q)
时间窗: Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment
The EDE-Q is the self-report version of the more intensive EDE interview. Research has documented that the EDE-Q performs well as a measure of change in treatment trials and has adequate convergence with the interview format. The EDE-Q generates the same frequency data for eating behaviors (binge eating and overeating) in the past 28 days, and the same four subscales reflecting eating disorder pathology. Score on a scale 0-6; higher=worse
次要结局
- Change in European Quality of Life (EuroQoL-5D)(Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment)
- Change in Patient Health Questionnaire-9 (PHQ-9)(Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment)
- Change in PTSD Checklist (PCL-5)(Pre treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment)
- Weight and Eating Quality of Life (WE-QoL)(Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment)
- Night Eating Questionnaire (NEQ)(Pre Treatment, 3 month post treatment, 9 month post treatment, 15 month post treatment)
- CBT Session Attendance (Treatment Dose)(3 month post-treatment)