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Effectiveness of an Online Psychoeducation Program for Improving Coping in People With a High Level of Dissociative Symptoms: A Pilot Randomized Waitlist-controlled Trial

Primary Purpose

Dissociation

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Online psychoeducational program
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dissociation

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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 25 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

Sites / Locations

  • The Chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Online psychoeducational program

Waitlist control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE)
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.

Secondary Outcome Measures

Dissociative Experiences Scale-Taxon (DES-T)
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 25. Higher scores indicate more frequent dissociative symptoms.

Full Information

First Posted
August 22, 2022
Last Updated
February 6, 2023
Sponsor
Chinese University of Hong Kong
Collaborators
Sigma Theta Tau International Honor Society of Nursing
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1. Study Identification

Unique Protocol Identification Number
NCT05519748
Brief Title
Effectiveness of an Online Psychoeducation Program for Improving Coping in People With a High Level of Dissociative Symptoms: A Pilot Randomized Waitlist-controlled Trial
Official Title
Effectiveness of an Online Psychoeducation Program for Improving Coping in People With a High Level of Dissociative Symptoms: A Pilot Randomized Waitlist-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Sigma Theta Tau International Honor Society of Nursing

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dissociation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online psychoeducational program
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online psychoeducational program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE)
Description
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.
Time Frame
Immediately and two months after completion of the intervention in the experimental group
Secondary Outcome Measure Information:
Title
Dissociative Experiences Scale-Taxon (DES-T)
Description
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 25. Higher scores indicate more frequent dissociative symptoms.
Time Frame
Immediately and two months after completion of the intervention in the experimental group
Other Pre-specified Outcome Measures:
Title
Emotion Regulation Questionnaire (ERQ)
Description
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.
Time Frame
Immediately and two months after completion of the intervention in the experimental group
Title
General Self-Efficacy Scale (GSES)
Description
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.
Time Frame
Immediately and two months after completion of the intervention in the experimental group

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 25 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stanley Lam, PhD
Phone
+852 39439932
Email
stanleylam@cuhk.edu.hk
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stanley Lam, PhD
Phone
+852 39439932
Email
stanleylam@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Stanley Lam, PhD
First Name & Middle Initial & Last Name & Degree
Andy Fung, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of an Online Psychoeducation Program for Improving Coping in People With a High Level of Dissociative Symptoms: A Pilot Randomized Waitlist-controlled Trial

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