Health At Every Size and Acceptance and Commitment Therapy vs. Behavioral Weight Loss for Obesity and Depression in Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Change in self-reported depression symptoms
研究概览
简要总结
The primary aim of this project is to conduct a randomized controlled pilot study evaluating the feasibility and potential effectiveness of a newly developed combined Health At Every Size and Acceptance and Commitment Therapy (HAES/ACT) treatment, known as Accept Yourself! compared to a commercial behavioral weight loss program, Weight Watchers (WW). Obese women (BMI ≥ 30) with Major Depressive Disorder will be randomly assigned to one of these two treatments. Depression, physical health, and other psychosocial outcomes will be assessed prior to treatment, at post-treatment, and at 3, 6, 9, and 12-month follow up assessments.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •English-speaking
- •Major Depressive Disorder (assessed using the Structured Clinical Interview for DSM-IV, SCID-IV)
- •Body Mass Index (BMI) greater than or equal to 30
- •Not taking medications or on stable medication regimens (i.e. no medication changes for six weeks prior to enrollment or during the study)
排除标准
- •current substance dependence
- •history of psychotic symptoms
- •high risk of suicide/self-harm
- •current enrollment in a weight-loss program
- •weight loss surgery in the past year
- •current psychotherapy
- •inability to postpone weight loss or depression treatment interventions for the duration of the study
- •taking antipsychotic, tricyclic, or oral corticosteroid medication
- •unwilling to be randomized to the study treatments
研究组 & 干预措施
Accept Yourself! Intervention
Combined Health At Every Size and Acceptance and Commitment Therapy Psychotherapy Group
干预措施: Accept Yourself! (Behavioral)
Behavioral Weight Loss
Weight Watchers groups
干预措施: Weight Watchers (Behavioral)
结局指标
主要结局
Change in self-reported depression symptoms
时间窗: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
As assessed by Patient Health Questionnaire-9 (PHQ-9)
Change in clinician assessed depression symptoms
时间窗: At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month follow-up assessments.
As assessed by clinician rated Hamilton Depression Rating Scale (HAM-D)
次要结局
- Change in systolic and diastolic blood pressure(At post-treatment (immediately following the three-month intervention) and 12 month follow up)
- Number of participants who did not complete an adequate dose of the intervention (at least 7 group visits)(At post-treatment (immediately following the three-month intervention))
- Change in self-reported physical activity(At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.)
- Change in fasting Lipids(At post-treatment (immediately following the three-month intervention) and at 12 month follow-up.)
- Change in fasting blood glucose(At post-treatment (immediately following the three-month intervention) and 12 month follow up)
- Change in eating disorder symptoms, measured by the Eating Disorders Diagnostic Scale (EDDS)(At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.)
- Change in obesity-related quality of life, measured by the Obesity-Related Well-Being Questionnaire (ORWELL97)(At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.)
- Change in obesity stigma, measured by the Weight Self-Stigma Questionnaire (WSSQ)(At post-treatment (immediately following the three-month intervention) and at 3, 6, 9, and 12-month assessments.)
- Change in cardiovascular fitness as assessed by six-minute walk test(At post-treatment (immediately following the three-month intervention) and at 12-month follow-up.)
- Change in weight(At post-treatment (immediately following the three-month intervention) and 12 month follow up)
研究者
Margit I. Berman
Associate Professor
Dartmouth-Hitchcock Medical Center