Effectiveness of an Online Psychoeducation Program for Improving Coping in People With a High Level of Dissociative Symptoms: A Pilot Randomized Waitlist-controlled Trial
May 23, 2024 updated by: Lam Kam Ki Stanley, Chinese University of Hong Kong
Subject Population Our study's target population is people with pathological dissociation in the community.
Research Design A pilot randomized waitlist-controlled trial will investigate the effects of an online psychoeducation program on coping, symptom management, and self-efficacy of people with pathological dissociation immediately (posttest-1) and 2-month (posttest-2) post-intervention. Supplementary semi-structured interviews will be conducted for process evaluation. The analysis and reporting of the trial will strictly follow the CONSORT guidelines.
Instrument The primary outcome of our study is the coping ability of individuals with pathological dissociation, which will be assessed by the Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE). The secondary outcome measures are dissociative symptoms, emotional regulation, and self-efficacy, which would be assessed by the Dissociative Experiences Scale-Taxon (DES-T), the Emotion Regulation Questionnaire (ERQ), and the General Self-Efficacy Scale (GSES) accordingly.
Procedure The online psychoeducation program is developed based on an integrative theoretical framework that integrates the Stress and Coping model, Cognitive-Behavioural Theory, Bandura's self-efficacy theory, and findings of our previous feasibility studies on this psychoeducational program. Participants will be recruited via posting on social media and online forums. A 16-session online psychoeducation program will be delivered to the participants in eight weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
101
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- agree to give informed consent and participate
- aged 18 or above
- self-reported symptoms or experiences of pathological dissociation
- screened positive on the Chinese version of the DES-T (i.e., DES-T score 20 or above) at a baseline screening
- able to understand and communicate in Chinese-Cantonese
- have access to the internet.
Exclusion Criteria:
- Individuals who have a reading disorder, cognitive impairment, dementia, or intellectual disabilities
- Individuals who are participating in any research studies
- Individuals who had participated in our previous feasibility study of the same intervention
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Online psychoeducational program
The intervention group will receive an online psychoeducational program for 8 weeks.
The psychoeducation package consists of 16 different sets of reading materials and post-session writing/reflection exercises, which will be delivered to the participants twice a week.
The program is designed to be a brief, trauma-informed, dissociation-focused education package that aims to enable users to better understand and cope with their post-traumatic and dissociative reactions and related life challenges.
There are specific psychoeducation elements in each session, such as: (1) safety issues planning, (2) understanding the impacts of trauma and stress, (3) understanding the concept of dissociation and integration of the personality, (4) identifying and coping with the post-traumatic and dissociative symptoms, (5) identifying trauma-related cognitive distortions.
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The intervention group will receive an online psychoeducational program for 8 weeks.
The psychoeducation package consists of 16 different sets of reading materials and post-session writing/reflection exercises, which will be delivered to the participants twice a week.
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Other: Waitlist control
The waitlist control group will receive an online psychoeducational program for 8 weeks a week after the completion of the two-month follow-up in the intervention group.
The psychoeducation package is identical to the program in the intervention group.
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The intervention group will receive an online psychoeducational program for 8 weeks.
The psychoeducation package consists of 16 different sets of reading materials and post-session writing/reflection exercises, which will be delivered to the participants twice a week.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE)
Time Frame: Immediately and two months after completion of the intervention in the experimental group
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Change in participants' coping strategies, as assessed using the Brief-COPE.
This measure has 28 items and is a commonly used self-report measure of coping strategies.
The Chinese version of the Brief-COPE had excellent internal consistency, test-retest reliability and content validity.
Higher scores indicate more significant use of that specific coping strategy.
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Immediately and two months after completion of the intervention in the experimental group
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dissociative Experiences Scale-Taxon (DES-T)
Time Frame: Immediately and two months after completion of the intervention in the experimental group
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Change in participants' pathological dissociative experiences, as assessed using the DES-T.
This measure has 8 items and can be used to screen for pathological dissociative experiences.
The Chinese version of the DES-T demonstrated good construct validity and good discriminant validity between participants with and without clinically diagnosed dissociative disorders, with a cut-off score of 20.
Higher scores indicate more frequent dissociative symptoms.
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Immediately and two months after completion of the intervention in the experimental group
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion Regulation Questionnaire (ERQ)
Time Frame: Immediately and two months after completion of the intervention in the experimental group
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Change in participants' emotion regulation, as assessed using the ERQ.
This measure has 10 items and is a self-report measure of emotion regulation.
It has good internal consistency and established construct validity.
The Chinese version of the ERQ also demonstrates good internal consistency and construct validity.
Higher scores indicate greater use of that particular emotion regulation strategy.
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Immediately and two months after completion of the intervention in the experimental group
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General Self-Efficacy Scale (GSES)
Time Frame: Immediately and two months after completion of the intervention in the experimental group
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Change in participants' self-efficacy, as assessed using the GSES.
This measure has 10 items and is to assess respondents' level of self-efficacy by using a 4-point Likert scale to rate their self-beliefs to cope with adversities in different life situations.
The total score ranges from 10 to 40, with the higher the score indicating the higher their perceived competence in managing difficult demands in life.
The Chinese version of the GSES also demonstrated excellent internal consistency and good construct validity.
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Immediately and two months after completion of the intervention in the experimental group
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
August 22, 2022
First Submitted That Met QC Criteria
August 25, 2022
First Posted (Actual)
August 29, 2022
Study Record Updates
Last Update Posted (Actual)
May 24, 2024
Last Update Submitted That Met QC Criteria
May 23, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6906334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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