Study Protocol for a Randomised Controlled Trial of Dance-movement Therapy for Adolescents With Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Beck Depression Inventory (BDI-21)
研究概览
简要总结
The aim of this research is to measure the effectiveness of Dance movement therapy in the treatment of adolescent depression.
详细描述
Research will start by recruitment of 140 patients (aged 13-17 years) from youth psychiatric outpatient clinic in Helsinki University Central hospital. They will be randomized to two groups. The intervention group will attend Dance movement therapy (DMT) for 12 weeks and the control group is getting treatment as usual (TAU). The outcome will be measured with self-report questionnaires and interviews measuring symptoms of depression and body image. Outcome measurements will be done before intervention, after intervention and 3 months after intervention has finished. The research will start in September 2022 and continue until the end of 2027. The results will be published in medical scientific journals during the year 2027
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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
- None
盲法说明
It is not possible to mask participants or care providers. No need for masking of investigator, since the primary outcome measures are self-reporting questionnaires
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of medium or severe depression; BDI 16 points or more. At least 4/9 symptoms of depression in K-SADS-PL interview
排除标准
- •Acute psychosis, psychotic depression, personality disorder, severe anorexia, substance misuse that is on a critical level
结局指标
主要结局
Beck Depression Inventory (BDI-21)
时间窗: baseline, 8 weeks, 12 weeks, 6 months
The self-report questionnaire to assess depressive symptoms, minimum 0 points, maximum 63 points, more severe depression with higher scores
Young Person's Clinical Outcomes in Routine Evaluation (YP-Core)
时间窗: baseline, 8 weeks, 12 weeks, 6 months
The self- report questionnaire to measure depressive and overal symptoms in youth, minimum 0 points, maximum 40 points, or median of scores, higher scores indicating more symptoms
次要结局
- Adolescent Depression Rating Scale (ADRS)(baseline, 12 weeks, 6 months)
- Body Image assessment(baseline, 12 weeks, 6 months)
研究者
Riikka Valjakka
Medical doctor
Helsinki University Central Hospital