Body, Breath & Mind - A Randomized Control Trial to Test the Efficacy of an Online Self-help Program for Negative Affect and Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Brief Patient Health Questionnaire (PHQ-9)
研究概览
简要总结
The aim of the study is to test Body, breath & mind (BBM, internet-based self-help program) for its efficacy in reducing depressive symptoms and improving quality of life. BBM combines methods of value-oriented behavioral activation with exercises from the Chinese healing practice Qi Gong,. BBM will be compared to an active control treatment (moodgym) and a waiting list control group. We expect significant differences to the waiting list control group. In comparison to the active control treatment we expect no significant differences.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All persons who suffer from depressive symptoms (subthreshold and clinical depression; PHQ-9 ≥10)
- •German speaking
- •Internet and email access
排除标准
- •The DSM-defined criteria A9 acute suicidality and A5 psychomotor agitation in the context of a depressive disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf & Cwik, 2017)
- •psychotic disorders, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf & Cwik, 2017)
- •major depression with psychotic features, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf & Cwik, 2017)
- •eating disorders, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf & Cwik, 2017)
- •current or past schizo-affective disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf & Cwik, 2017)
- •current substance use disorder, verified using the Diagnostic Interview in Mental Disorders in form of the Mini-DIPS (Margraf & Cwik, 2017)
- •inability to participate in the program due to physical, practical, or other reasons.
研究组 & 干预措施
Body, Breath & Mind
The program "Body, Breath & Mind" is a minimally guided self-help program to improve mood. It contains a total of eight modules, which are to be completed in a weekly rhythm. Each module includes Qi Gong exercises, and instructions and exercises for value-based behavioral activation used in behavioral therapy for depression (Hofheinz, Heidenreich & Michalak, 2017). If possible, the entire program should be completed within a period of 8 weeks.
干预措施: Body, Breath & Mind (Behavioral)
Moodgym
Moodgym is an interactive training program for the prevention and reduction of depressive symptoms. It is based on the methods and techniques of cognitive behavioral therapy and includes five modules: feelings, thoughts, developing alternative thoughts, deal with stress and relationship. In addition to the modules, there is a workbook section where personal results and responses are stored.The effectiveness of the programme has been proven in clinical trials (Loebner et al., 2018).
干预措施: Moodgym (Behavioral)
Waitlist control group
Participants in the waitlist control group are given access to the Body, Breath & Mind program after eight weeks, provided they have participated in the previous surveys in the form of a diagnostic pre-, peri-, and post-module.
干预措施: Body, Breath & Mind (Behavioral)
结局指标
主要结局
Brief Patient Health Questionnaire (PHQ-9)
时间窗: Post-Measurement after 8 weeks
Depression
次要结局
- Short Form (36) Health Survey(Post-Measurement after 8 weeks)
- Brief Patient Health Questionnaire (PHQ-9)(6-Month-Follow-Up)