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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: An integrated online program

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stanley Kam Ki Lam, PhD; Phone Number: (852)39439932; Email: stanleylam@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Sha Tin, New Territories, Hong Kong, 852
      • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group (an integrated online program); 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; Our integrated online program combines validated psychoeducational materials on dissociation with components of strucutred writing therapy.
Other: Waitlist control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dissociative symptom severity	The Chinese version Dissociative Experiences Scale-Taxon (DES-T) will be used to measure dissociative symptom severity.	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.	The outcome will be measured at baseline (T0) and immediately post-intervention (T1).

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: July 23, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Actual): July 26, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: post-traumatic stress; dissociation; structured writing; pilot study
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 21220891

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No