Effect of Evidence-based Digital Cognitive Behavior Therapy for Adolescents With Nonsuicidal Self-Injury Disorder: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Ottawa Self-injury Inventory（OSI）
研究概览
简要总结
To evaluate if evidence-based digital cognitive behaviour therapy for adolescents is an efficacious treatment when delivered as an adjunctive treatment to treatment as usual, compared to a control group consisting of treatment as usual.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •5 nonsuicidal self-injury episodes past year
- •1 nonsuicidal self-injury episodes past month having at least one parent who committed to participate in the program
排除标准
- •Severe suicidal ideation a diagnosis of psychotic or ongoing (past month) substance dependence the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
研究组 & 干预措施
Evidence-based digital CBT group
Participants will receive 6 weeks of evidence-based digital cognitive behaviour therapy, adjunctive to treatment as usual, as provided in the community or research group.
干预措施: Evidence-based digital cognitive behaviour therapy (Behavioral)
Health Education group
Participants will receive health education for 6 weeks, adjunctive to treatment as usual, as provided in the community or research group.
干预措施: Health Education (Behavioral)
结局指标
主要结局
Ottawa Self-injury Inventory（OSI）
时间窗: From the date of baseline assessment (enrollment) until the date of 12-month follow-up, assessed at baseline, post-treatment (Day 1 of the week following treatment completion), and 1 month, 6 months, and 12 months after post-treatment.
Assessing the frequency and severity of nonsuicidal self-injury
次要结局
- General Anxiety Disorder-7(Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.)
- Beck's Suicide Intent Scale(Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.)
- Self-harm behaviour craving visual analog scale(Change from baseline (Day 1 of study enrollment), assessed every week during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.)
- Difficulties in Emotion Regulation Scale - 16-item version (DERS)(Change from baseline (Day 1 of study enrollment), assessed at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.)
- Patient Health Questionnaire-9(Change from baseline (Day 1 of study enrollment), assessed every 2 weeks during the 6-week treatment period, at post-treatment (Day 1 of the week following treatment completion), and at 1 month, 6 months, and 12 months after post-treatment.)
研究者
Yi Zhong
Peking University
Peking University Sixth Hospital