NCT05293691Unknown不适用
Body, Breath & Mind - A Randomized Control Trial to Test the Efficacy of an Online Self-help Program for Negative Affect and Depression
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 303
- 试验地点
- 2
- 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.
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
- Brief Patient Health Questionnaire (PHQ-9)(6-Month-Follow-Up)
- Short Form (36) Health Survey(Post-Measurement after 8 weeks)
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Mind-body Medicine for Patients With Malignant Hematological DiseasesHematologic NeoplasmsNCT03735992Universität Duisburg-Essen94
已完成
不适用
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adults in GazaPosttraumatic Stress DisorderNCT01595464The Center for Mind-Body Medicine148
已完成
不适用
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Children in GazaPosttraumatic Stress DisorderNCT01595477The Center for Mind-Body Medicine114
已完成
不适用
Mind-Body Skills Groups for the Treatment of War-Related Trauma in Adolescents in GazaPosttraumatic Stress DisorderNCT01595490The Center for Mind-Body Medicine121
已完成
不适用
A Skills-Based Program Delivered Via Secure Live Video to Patients With Acute Musculoskeletal TraumaMusculoskeletal InjuryFractureNCT03405610Massachusetts General Hospital55