Internet Delivered Emotion Regulation Individual Therapy for Adolescents With Nonsuicidal Self-Injury: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Deliberate Self-Harm Inventory Youth version (DSHI-Y)
研究概览
简要总结
To evaluate if Internet delivered emotion regulation individual therapy for adolescents is an efficacious treatment when delivered as adjunctive to treatment as usual compared to a control group consisting of treatment as usual.
详细描述
Statistical Analyses
Treatment effects will be evaluated according to the intention-to-treat principle. Primary end-point for all outcomes is post-treatment. Secondary end-point include a controlled 3 month follow-up.
Primary Analysis
The primary outcome analysis will include treatment group (ERITA , TAU) and weekly reports of NSSI frequency measured once every week 4 weeks prior to treatment start, once every week during treatment, and once every week four weeks after treatment termination. Regression analysis modelled for count data will be used to estimate trend over time. Four weeks after treatment termination will be considered primary endpoint. Pairwise contrasts (group x time interaction) from the regression model will be used to evaluate between-group differences at primary endpoint (4 weeks after treatment termination).
Secondary Analyses
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 (Outcomes Assessor)
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
- •≥ 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 parent program
排除标准
- •Severe suicidal ideation
- •a diagnosis of psychotic or bipolar I disorder or ongoing (past month) substance dependence
- •the presence of co-occurring psychological disorders that required immediate treatment (i.e., severe anorexia nervosa)
- •insufficient understanding of the Swedish language
结局指标
主要结局
Deliberate Self-Harm Inventory Youth version (DSHI-Y)
时间窗: Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended
Frequency of nonsuicidal self-injury
次要结局
- Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)(Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended)
- the 21-item Depression Anxiety Stress Scales (DASS-21)(Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Borderline Symptom List Supplement(Change from baseline, once every week during treatment (0-12 weeks after baseline), 3 and 12 months after treatment has ended)
- Difficulties in Emotion Regulation Scale - 36 item version (DERS)(Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- Childrens Global Assessment Scale(Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended)
- Acceptance and Action Questionnaire(Change from baseline, 12 weeks after treatment starts, 3 and 12 months after treatment has ended)
- The Clinical Global Impressions -Severity and Improvement scales(Change from baseline, 16 weeks after treatment starts, 3 months after treatment has ended)
研究者
Clara Hellner Gumpert
PhD, Professor
Karolinska Institutet