A Blended Version of the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Chinese Adolescents With Non-suicidal Self-injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) to address non-suicidal self-injury 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. The study will assess the feasibility, acceptability, and preliminary efficacy of this intervention through a single-arm design, which includes pretest, posttest, and follow-up assessments.
详细描述
The blended UP-A includes 8 weekly modules, 6 of which (Module 2 - 7)are online self-guided sessions. The online self-guided sessions will last approximately 45 minutes each. Over the course of these 6 weeks, participants will also have 6 therapist-guided online sessions via videoconference, each lasting 30 minutes. Two face-to-face individual sessions are scheduled, one at the beginning of each (Module 1) and one at the end (module 8), each with an expected duration of 90 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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, manic or hypomanic episode, 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
Intervention group
Participants will receive an 8-week blended version of the Unified Protocol for Adolescents.
干预措施: Unified protocol for transdiagnostic treatment of emotional disorders in adolescents (Behavioral)
结局指标
主要结局
Adherence
时间窗: Immediately after the intervention
Adherence to the intervention will be measured by the number of sessions attended and the number of participants who complete at least 70% of the sessions, the timing of these sessions (within the designated week or not), the number of interactive exercises completed in each session, and the completion of home assignment tasks.
Dropout rates
时间窗: Immediately after the intervention
Dropout rates are defined as the number of participants who dropped out from the intervention before completing it.
The Feasibility and Acceptability Questionnaire (FAQ)
时间窗: Immediately after the intervention
The FAQ will be used to evaluate the feasibility and acceptability of the intervention. The FAQ consists of three subscales, each containing six items: (1) experience using the online platform, (2) satisfaction with the program, (3) therapeutic alliance. The higher scores indicate greater feasibility and acceptability.
Participants' perspectives on the intervention
时间窗: Immediately after the intervention
Participants' perspectives on the intervention will be assessed through semi-structured interviews, exploring the factors that facilitate or hinder their adherence to and completion of the program.
次要结局
- Emotion regulation strategies(baseline, immediately after the intervention, and 1-month after the intervention)
- Non-suicidal self-injury(baseline, immediately after the intervention, and 1-month after the intervention)
- Emotion dysregulation(baseline, immediately after the intervention, and 1-month after the intervention)
- Depression(baseline, immediately after the intervention, and 1-month after the intervention)
- Anxiety(baseline, immediately after the intervention, and 1-month after the intervention)
研究者
Jian-Jun Ou
Principal Investigator
Central South University