Compassion-focused Intervention for Women With Mood Disorders Seeking Treatment for Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Feasibility of recruitment from community-based clinic
研究概览
简要总结
Women with mood disorders are vulnerable to the negative consequences associated with obesity, and face considerable challenges with adherence to behavioral weight management interventions. Strategies are needed to support the psychological well-being of this population, and improve adherence to weight-related treatment. The goal of this preliminary study is to determine the acceptability of a group-based compassion-focused psychoeducational intervention among women with mood disorders who are attending a behavioral weight management program.
详细描述
Pilot feasibility trial to examine the acceptability and efficacy of compassion-based intervention in reducing indices of psychopathology (i.e., internalized weight stigma, mood symptoms), and improving weight management outcomes (i.e., physical activity behaviour, dieting behaviour, weight loss) among women with mood disorders undergoing lifestyle weight management. In this proof of concept study, adult females with a diagnosis of major depressive disorder of bipolar disorder will be randomized into two arms: weight management treatment as usual + psychoeducation group; weight management as usual + control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed of the nature of the study and have agreed to and are able to read, review, and sign the informed consent form. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
- •Female participants 18 - 65 years of age, inclusive, at the time of screening.
- •Available and able to attend weekly group meeting on assigned dates.
- •Diagnosis of major depressive disorder or bipolar disorder by a physician within the past 12 months, as indicated in WMC medical records and confirmed by MINI.
- •Actively pursuing lifestyle weight management at WMC, with evidence of booked follow-up appointment.
- •Weight status of at least 25kg/m2, as indicated by data from last appointment at WMC.
- •Access to a computer and email account in order to complete online questionnaires
排除标准
- •Enrolled in surgical management of obesity at WMC.
- •Active substance abuse/dependence disorder, current suicidality, or active episode of psychosis.
- •Presence of a hearing or visual impairment that will prevent completing the online surveys and from participating in a group discussion weekly meeting
结局指标
主要结局
Feasibility of recruitment from community-based clinic
时间窗: 7-months (from baseline to 6-month follow-up)
Proportion of eligible participants who agree to participate in the study
Adherence to the 6-week intervention
时间窗: 6 weeks (from baseline to end of treatment)
Proportion of sessions attended, and minutes spent weekly on home practice exercises
次要结局
- Changes in internalized weight bias(7 months (from baseline to 6-month follow-up))
- Changes in physical activity engagement(7 months (from baseline to 6-month follow-up))
- Future adherence to weight management program(7 months (from baseline to 6-month follow-up))
- Changes in depressive symptoms(7 months (from baseline to 6-month follow-up))
研究者
Dr. Eva Pila
Assistant Professor
University of Western Ontario, Canada