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Clinical Trials/NCT06523023
NCT06523023
Not Yet Recruiting
N/A

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

Chinese University of Hong Kong1 site in 1 country72 target enrollmentAugust 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress Disorders, Post-Traumatic
Sponsor
Chinese University of Hong Kong
Enrollment
72
Locations
1
Primary Endpoint
Post-traumatic Stress Disorder (PTSD) symptom severity
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2024
End Date
March 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lam Kam Ki Stanley

Research Assistant Professor

Chinese University of Hong Kong

Eligibility Criteria

Inclusion Criteria

  • (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.

Exclusion Criteria

  • (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.

Outcomes

Primary Outcomes

Post-traumatic Stress Disorder (PTSD) symptom severity

Time Frame: 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.

Secondary Outcomes

  • 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).)

Study Sites (1)

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