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临床试验/NCT06390293
NCT06390293
已完成
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The Effectiveness of Group-Delivered Written Exposure Therapy for PTSD and Complex PTSD Among Chinese Adolescents: A Pilot Randomized Controlled Trial

Peking University1 个研究点 分布在 1 个国家目标入组 53 人2024年5月1日
适应症PTSD

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
PTSD
发起方
Peking University
入组人数
53
试验地点
1
主要终点
PTSD Checklist-5 (PCL-5)
状态
已完成
最后更新
上个月

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.

注册库
clinicaltrials.gov
开始日期
2024年5月1日
结束日期
2025年6月1日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Peking University
责任方
Principal Investigator
主要研究者

Yinyin Zang, PhD

Research Fellow

Peking University

入排标准

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)

研究点 (1)

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