An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms: a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Post-traumatic Stress Disorder (PTSD) symptom severity
研究概览
简要总结
Objectives:
To evaluate the feasibility, acceptability, safety, and preliminary effects of an integrated online program with psychoeducation and expressive writing components for people with probable post-traumatic stress disorder (PTSD) and coexisting dissociative symptoms.
Hypotheses to be tested:
The program will be feasible, acceptable, and safe to participants. When compared with the waitlist control group, participants in the treatment group will report significantly lower PTSD symptom severity, lower dissociative symptom severity, and greater improvement on coping immediately post-intervention.
Design and subjects:
An assessor-blind, two-arm, randomised waitlist-controlled pilot study is proposed; 90 community adults with significant PTSD and dissociative symptoms will be recruited.
Instruments:
The PTSD Checklist 5, Dissociative Experiences Scale-Taxon, and Brief Coping Orientation to Problems Experienced inventory will be used. Semi-structured interviews will be conducted for process evaluation.
Intervention:
A 10-week integrated online program with psychoeducational and expressive writing components.
Main outcome measures:
The primary outcome is PTSD symptom severity. The secondary outcomes are dissociative symptom severity and coping. The feasibility, acceptability, and safety of the program will also be examined.
Data analysis: Feasibility and acceptability of the program will be assessed by examining the attrition rate, adherence rate, duration of subject recruitment, and post-program individual interviews. Generalised estimating equations with covariate adjustments will be used to examine the preliminary effects of the program.
Expected results:
Adults in the community who experienced significant PTSD and dissociative symptoms will become more resourceful to cope with their traumatic experiences and show more improvements on PTSD and dissociative symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Allocation concealment will be ensured with the help of an independent statistician, who will be responsible for conducting the randomisation but will not be involved in any other parts of the project.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) be Hong Kong Chinese residents between the ages of 18 and 65; (b) be able to read, write, and speak in Chinese/Cantonese; (c) meet the operational definitions of "probable PTSD" and "coexisting dissociative symptoms" in screening [score ≥31 on the Chinese version of the PTSD Checklist 5 (PCL-5) and ≥20 on the Chinese version of the Dissociative Experiences Scale-Taxon (DES-T)]; and (d) have access to a digital device with internet connectivity, such as a smartphone, tablet, or computer.
排除标准
- •(a) having participated in or currently receiving other psychoeducation/psychotherapies for PTSD or dissociative symptoms; (b) having clinically significant medical conditions that may interfere with safe study participation; (c) concurrent substance dependence, acute suicidality, psychosis, or gross cognitive impairment; and (d) visual, language, or communication difficulties.
结局指标
主要结局
Post-traumatic Stress Disorder (PTSD) symptom severity
时间窗: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
The Chinese version PTSD Checklist 5 (PCL-5) will be used to measure DSM-5 PTSD symptom severity.
次要结局
- Dissociative symptom severity(The outcome will be measured at baseline (T0) and immediately post-intervention (T1).)
- Coping(The outcome will be measured at baseline (T0) and immediately post-intervention (T1).)
研究者
Lam Kam Ki Stanley
Research Assistant Professor
Chinese University of Hong Kong