NCT05519748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

1.2 years

First QC Date

August 22, 2022

Last Update Submit

May 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately and two months after completion of the intervention in the experimental group

Secondary Outcomes (1)

  • Dissociative Experiences Scale-Taxon (DES-T)

    Immediately and two months after completion of the intervention in the experimental group

Other Outcomes (2)

  • Emotion Regulation Questionnaire (ERQ)

    Immediately and two months after completion of the intervention in the experimental group

  • General Self-Efficacy Scale (GSES)

    Immediately and two months after completion of the intervention in the experimental group

Study Arms (2)

Online psychoeducational program

EXPERIMENTAL

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.

Behavioral: Online psychoeducational program

Waitlist control

OTHER

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.

Behavioral: Online psychoeducational program

Interventions

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.

Online psychoeducational programWaitlist control

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lam SKK, Fung HW. Can dissociative symptoms be explained by coping and emotion regulation? A longitudinal investigation. Psychol Trauma. 2025 Nov;17(8):1691-1698. doi: 10.1037/tra0001713. Epub 2024 Jun 20.

MeSH Terms

Conditions

Dissociative Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

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

Study Record Dates

First Submitted

August 22, 2022

First Posted

August 29, 2022

Study Start

September 1, 2022

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations