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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05519748
Other study ID # 6906334
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date November 30, 2023

Study information

Verified date May 2024
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date November 30, 2023
Est. primary completion date November 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Hong Kong The Chinese University of Hong Kong Hong Kong

Sponsors (2)

Lead Sponsor Collaborator
Chinese University of Hong Kong Sigma Theta Tau International Honor Society of Nursing

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Other Emotion Regulation Questionnaire (ERQ) 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. Immediately and two months after completion of the intervention in the experimental group
Other General Self-Efficacy Scale (GSES) 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. Immediately and two months after completion of the intervention in the experimental group
Primary 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 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 20. Higher scores indicate more frequent dissociative symptoms. Immediately and two months after completion of the intervention in the experimental group
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