A Randomized Controlled Trial Evaluating the Efficacy of a Blended Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-Suicidal Self-Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Non-suicidal self-injury behavior
研究概览
简要总结
This study is an open-label, randomized controlled trial evaluating the efficacy of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) in reducing non-suicidal self-injury (NSSI) among Chinese adolescents. This program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. Its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. In turn, this helps reduce self-injury impulses and behaviors. The UP-A is adapted to the Chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions.
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
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 12 and 17 years;
- •Engaged in non-suicidal self-injury (NSSI) at least 5 times in the past 12 months, with at least 1 episode in the past month;
- •Minimum education level of primary school or above;
- •Participant and guardian fully understand the research content and agree to participate, with signed informed consent provided.
排除标准
- •Suicide attempts in the past month or a score of ≥17 on the MINI National Neuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk of suicide;
- •Diagnosis of a psychotic disorder, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;
- •Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;
- •Currently receiving other professional psychotherapy or participating in another NSSI intervention study;
- •Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;
- •Having received electroconvulsive therapy (ECT) within the past 6 months.
研究组 & 干预措施
UP-A + Treatment as Usual
Participants receive standard psychiatric care (e.g., pharmacotherapy) plus a blended version of the Unified Protocol for Adolescents (UP-A), which includes both face-to-face and online sessions over 8 weeks.
干预措施: a blended version of the Unified Protocol for Adolescents (UP-A) (Behavioral)
UP-A + Treatment as Usual
Participants receive standard psychiatric care (e.g., pharmacotherapy) plus a blended version of the Unified Protocol for Adolescents (UP-A), which includes both face-to-face and online sessions over 8 weeks.
干预措施: Standard psychiatric treatment (Drug)
Treatment as Usual
Participants in the control group will receive standard psychiatric care as provided by their treating clinicians, including pharmacotherapy as appropriate. No additional psychological intervention will be provided during the study period.
干预措施: Standard psychiatric treatment (Drug)
结局指标
主要结局
Non-suicidal self-injury behavior
时间窗: Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months)
The Adolescent Self-Harm Behavior Scale includes 18 items describing forms of self-harm. The scale is divided into two dimensions: frequency and severity of self-harm. Self-harm frequency is scored on a 4-point scale (0-3), with the following categories: 0 times, 1 time, 2-4 times, and more than 5 times. The severity of physical injury is scored on a 5-point scale (0-4), with the following categories: none, mild, moderate, severe, and extremely severe. The product of frequency and injury severity for each item is used as the overall score for NSSI, with higher scores indicating more severe NSSI behavior.
次要结局
- Depression(Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months))
- Anxiety(Up to 3 months post-baseline (measured at baseline, 1, 2, and 3 months))