An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms

NCT06523023 | Not Yet Recruiting DMC

• 1 other identifier: 21220891
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

post-traumatic stress; dissociation; structured writing; pilot study

Outcome Measures

Primary Outcomes (1)

• 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.

  The outcome will be measured at baseline (T0) and immediately post-intervention (T1).

Secondary Outcomes (2)

• 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 Arms (2)

Treatment group (an integrated online program)

EXPERIMENTAL

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

Waitlist control group

OTHER

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

Interventions

An integrated online program BEHAVIORAL

Our integrated online program combines validated psychoeducational materials on dissociation with components of strucutred writing therapy.

Treatment group (an integrated online program); Waitlist control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, New Territories, 852, Hong Kong

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Dissociative Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Stanley Kam Ki Lam, PhD

CONTACT

(852)39439932; stanleylam@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 26, 2024
• Study Start: August 1, 2024
• Primary Completion: November 30, 2025
• Study Completion: March 30, 2026
• Last Updated: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)