An interventional study of An integrated online program in Stress Disorders, Post-Traumatic, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care
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.
1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.
This study's planned enrollment of 72 is above the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.
Browse Stress Disorders, Traumatic studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
(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.
Our intervnetion is an integrated online program using psychoeducation and expressive writing. It is a 10-week program that consists of a 5-week psychoeducation module and a 5-week expressive writing module.
Behavioral: An integrated online program
After the treatment group has received and completed the integrated online program, the waitlist control group will receive the same program that is identical in content, procedures, and activities to the one received by the treatment group
Behavioral: An integrated online program
Our integrated online program combines validated psychoeducational materials on dissociation with components of strucutred writing therapy.
Post-traumatic Stress Disorder (PTSD) symptom severity
The Chinese version PTSD Checklist 5 (PCL-5) will be used to measure DSM-5 PTSD symptom severity.
Time frame: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Dissociative symptom severity
The Chinese version Dissociative Experiences Scale-Taxon (DES-T) will be used to measure dissociative symptom severity.
Time frame: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Coping
The Chinese version Brief Coping Orientation to Problems Experienced inventory (Brief-COPE) will be used to measure coping.
Time frame: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Plan to share: No — The data generated and analysed during the current study will not be shared publicly. This decision is based on concerns regarding participant privacy and confidentiality, as well as the sensitive nature of the collected information. Therefore, the study's data will only be accessible to the research team and authorised personnel involved in the project.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong