The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD 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
- 2
- 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 group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD in Chinese adolescents through a randomized controlled trial. A total of 50 participants will be recruited, with 25 randomized to the GWE group and 25 to the waiting-list (WL) group. The GWE intervention will consist of 5 to 8 group sessions. The primary outcome, PTSD and CPTSD symptom severity, will be assessed at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.
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)
盲法说明
Randomization was conducted by an independent research assistant, and the random sequence was concealed from the investigator until the process was completed.
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) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
- •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.
研究组 & 干预措施
GWE
干预措施: Group-delivered guided written exposure therapy (Behavioral)
Waiting-List (WL) condition
干预措施: Waiting-List (WL) condition (Behavioral)
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 adolescents.
次要结局
- Patient Health Questionnaire 9-item(baseline, post treatment(2 weeks), 6 weeks, 14 weeks)
- Generalized Anxiety Disorder 7-item(baseline, post treatment(2 weeks), 6 weeks, 14 weeks)
- The Strengths and Difficulties Questionnaire(baseline, post treatment(2 weeks), 6 weeks, 14 weeks)
研究者
Yinyin Zang, PhD
Research Fellow
Peking University