Immunological Mechanisms in the Treatment of Depression and Their Significance in TaKeTiNa Music Therapy as a New Psychotherapeutic Method. A Waitlist-controlled Randomized Group Pilot Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Comparison of depression severity (HAMD 17)
研究概览
简要总结
The goal of this clinical study's to analyse the impact of TaKeTiNa music therapy in depressed patients.
The main question[s] it aims to answer are:
. Can TaKeTiNa result in a significant pre-to-post intervention decline of depression severity 2. Can TaKeTiNa result in a significantly lower post-intervention depression severity in the T1/T2 group than in the W1/W2 group.
Participants will
- be randomly assigned to the two groups, intervention vs. waitlist
- receive either an eight week TaKeTiNa music therapy or waitlist
- be analysed using questionaires, blood taking, cortisol saliva analysis, measured heart rate variability
Researchers will compare a waitlist to see if TakeTiNa is superior to waitlist
详细描述
One third of the depressed patients do not respond adequately to conventional treatment. This seems to be associated with increased production of proinflammatory cytokines such as TNF-a and IL-1, as well as dysregulation of cortisol levels. This project aims to investigate Investigate the effectiveness of TaKeTiNa music therapy in the treatment of patients with clinical diagnosis of moderate to severe depression Investigate the physiological and pathophysiological effects of TaKeTiNa using novel blood based biomarkers of depression, especially LDL cholesterol as well as on immune system function in order to establish immune system based biomarkers for better diagnosis and therapy monitoring of major depressive disorder.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Major depressive disorder Ability to walk, speak, and clap
排除标准
- •psychotic symptoms
- •acute suicidality
- •prior intolerance to body therapeutic methods
结局指标
主要结局
Comparison of depression severity (HAMD 17)
时间窗: four month
Comparison of depression severity (HAMD 17) in the intervention group from beginning of Therapy, during the course of therapy, after completion of therapy and after an 8-week follow-up period and in comparison to control group (pre intervention, during intervention, post intervention and after follow up)
次要结局
- Differences in Depression severity (BDI II)(four month)
- Differences in anxiety (BAI)(four month)
- Differences in Cortisol levels(four month)
- Differences in Resilience(four month)
- Differences in Composition of adaptive cellular immunity(four month)
- Differences in Adverse events(four month)
- Differences in Mindful Attention and Awareness(four month)
- Differences in Heart rate variability(four month)
- Differences in serum lipid levels(four month)
- Differences in social anxiety(four month)
- Differences in enzymes of sphingolipid metabolism(four month)
- Differences in Physical activity(four month)