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NCT Number: NCT06523023

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

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Dissociative Disorders Mental Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Shatin, New Territories, 852, Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

An integrated online program

Behavioral

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

Primary outcomes

  1. 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

  1. Dissociative symptom severity

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

    The Chinese version Dissociative Experiences Scale-Taxon (DES-T) will be used to measure dissociative symptom severity.

  2. Coping

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

    The Chinese version Brief Coping Orientation to Problems Experienced inventory (Brief-COPE) will be used to measure coping.

Study contacts

Contact information is provided by the study sponsor or research team.

Stanley Kam Ki Lam, PhD

CONTACT

[email protected]

(852)39439932

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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