The Effectiveness of Group-Delivered Written Exposure Therapy for PTSD and Complex PTSD Among Chinese Adolescents: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- PTSD Checklist-5 (PCL-5)
研究概览
简要总结
The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 50 participants, with 25 randomized to the GWE group and 25 randomized to the waiting list (WL) group. The GWE intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) and ITQ-CA (International Trauma Questionnaire-Child and Adolescent Version) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 10-18 years.
- •Meeting full or subthreshold PTSD (up to one symptom missing).
- •If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
- •Capable of writing and understanding written instructions.
排除标准
- •Presence of severe psychopathology necessitating immediate medical attention
- •Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future
- •Evidence of a moderate or severe traumatic brain injury
- •Currently undergoing psychotherapy specifically for PTSD.
结局指标
主要结局
PTSD Checklist-5 (PCL-5)
时间窗: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
PCL-5 was a 20-item self-report scale that assesses PTSD DSM-5 diagnosis and symptom severity in the past month. Items were rated on a 5-point Likert scale from 0 ("not at all") to 4("extremely").The Chinese version of PCL-5 has shown good psychometric properties in trauma-affected Chinese children.
CPTSD symptoms
时间窗: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
CPTSD symptoms include two parts: PTSD symptoms were assessed using six PCL-5 items mapped to ICD-11 domains: re-experiencing (items 2 and 3), avoidance (items 6 and 7), and sense of current threat (items 17 and 18). Disturbances in self-organization (DSO) were measured using the 6-item DSO subscale of the International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA), which has demonstrated good validity in Chinese adolescent samples. The resulting 12-item composite yielded total scores ranging from 0 to 48, consistent with ITQ-CA scoring conventions.
次要结局
- Patient Health Questionnaire-9 (PHQ-9)(baseline,post treatment(2 weeks), 6 weeks, 14 weeks)
- Generalized Anxiety Disorder 7-item scale(baseline,post treatment(2 weeks), 6 weeks, 14 weeks)
- Strengths and Difficulties Questionnaire (SDQ)(baseline,post treatment(2 weeks), 6 weeks, 14 weeks)
研究者
Yinyin Zang, PhD
Research Fellow
Peking University