The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- CPTSD Symptom Severity (self-report)
研究概览
简要总结
This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured 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
- Single (Outcomes Assessor)
盲法说明
Randomization will be conducted by an independent research assistant, and the random sequence will be concealed from the investigators until the process is completed. Outcome assessors will be blinded to participants' treatment conditions.
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
- •Aged between 10 and 18 years;
- •Meet the diagnostic or subclinical criteria for Complex PTSD (C-PTSD), defined as missing at most one symptom from either the PTSD or DSO clusters;
- •Possess sufficient literacy and language skills to complete writing-based tasks;
- •Be able to understand the study procedures and complete the required assessments;
- •Provide written informed consent, with consent also obtained from their legal guardians.
排除标准
- •Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
- •Presence of a severe physical illness that would impair the ability to engage in the intervention;
- •Assessed as being at high suicidal risk (e.g., current suicidal ideation with intent or plan, recent suicide attempt within the past 12 months, or severe self-harm behaviors);
- •Ongoing exposure to traumatic events;
- •Currently receiving other trauma-focused psychological treatments.
研究组 & 干预措施
GWE-C
干预措施: Group Guided Written Exposure Therapy for CPTSD (GWE-C) (Behavioral)
Supportive group
干预措施: Supportive Group (Behavioral)
结局指标
主要结局
CPTSD Symptom Severity (self-report)
时间窗: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA ) is a self-report measure that assesses ICD-11 PTSD and CPTSD. The measure includes 6 core items of PTSD symptom clusters (ie. re-experiencing, avoidance, sense of threat), 6 core items of Disturbances in Self-Organization (DSO) clusters (ie affective dysregulation, negative self-concept, disturbed relationships). Each item is rated from 0(not at all) to 4(extremely). The Chinese version has been demonstrated good psychometric properties (Ho et al., 2022).
CPTSD Symptom Severity (interview)
时间窗: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
The Child CPTSD Symptom Interview (CCSI) is a 12-item semi-structured interview developed by adapting items from the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I) and the International Trauma Interview (ITI).The PTSD section of the CCSI includes two items for each of the three PTSD symptom clusters, following the structure of the CPSS-5-I: re-experiencing (Re), characterized by flashbacks or nightmares; avoidance (Av), referring to avoidance of internal or external reminders of the traumatic event; and a sense of current threat (Th), expressed through hypervigilance or exaggerated startle reactions.The second part assesses Disturbances in Self-Organization (DSO) symptoms, based on the structure of the ITI , with two items per DSO symptom cluster.
次要结局
未报告次要终点
研究者
Yinyin Zang, PhD
Principle Investigator
Peking University