Stress Disorders, Post-TraumaticNCT06523023
An Integrated Online Program Using Psychoeducation and Expressive Writing for People With Probable Post-traumatic Stress Disorder and Coexisting Dissociative Symptoms
A study testing An integrated online program in people with Stress Disorders, Post-Traumatic, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- An integrated online program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2024to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
The Chinese University of Hong Kong
Shatin, New Territories, 852
About this study
Official 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
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.
Read more
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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- An integrated online program
- Keywords
- post-traumatic stress; dissociation; structured writing; pilot study
- Medical subject headings
- Stress Disorders, Post-Traumatic, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An integrated online programBehavioural
Our integrated online program combines validated psychoeducational materials on dissociation with components of strucutred writing therapy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (an integrated online program) | Experimental | Our intervnetion is an integrated online program using psychoeducation and expressive writing. It is a 10-week program that consists of a 5-week psychoeducation module and a 5-week expressive writing module. Receives: Behavioral: An integrated online program |
| Waitlist control group | Other | After the treatment group has received and completed the integrated online program, the waitlist control group will receive the same program that is identical in content, procedures, and activities to the one received by the treatment group Receives: Behavioral: An integrated online program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-traumatic Stress Disorder (PTSD) symptom severity
The Chinese version PTSD Checklist 5 (PCL-5) will be used to measure DSM-5 PTSD symptom severity.
Measured: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Secondary outcomes (2)
Dissociative symptom severity
The Chinese version Dissociative Experiences Scale-Taxon (DES-T) will be used to measure dissociative symptom severity.
Measured: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Coping
The Chinese version Brief Coping Orientation to Problems Experienced inventory (Brief-COPE) will be used to measure coping.
Measured: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lam Kam Ki Stanley, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523023
- Sponsor's protocol ID
- 21220891
- Status last verified
- Jul 2024
- First submitted
- 23 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data generated and analysed during the current study will not be shared publicly. This decision is based on concerns regarding participant privacy and confidentiality, as well as the sensitive nature of the collected information. Therefore, the study's data will only be accessible to the research team and authorised personnel involved in the project.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06523023
- Acronym / sponsor ID
- 21220891
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- post-traumatic stress; dissociation; structured writing; pilot study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (an integrated online program) | Experimental | Behavioral: An integrated online programOur intervnetion is an integrated online program using psychoeducation and expressive writing. It is a 10-week program that consists of a 5-week psychoeducation module and a 5-week expressive writing module. |
| Waitlist control group | Other | Behavioral: An integrated online programAfter the treatment group has received and completed the integrated online program, the waitlist control group will receive the same program that is identical in content, procedures, and activities to the one received by the treatment group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An integrated online programOur integrated online program combines validated psychoeducational materials on dissociation with components of strucutred writing therapy. | Behavioural | Treatment group (an integrated online program), Waitlist control group |
Primary outcome
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.
2 secondary outcomes
Dissociative symptom severity
Time frame: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Coping
Time frame: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No. The data generated and analysed during the current study will not be shared publicly. This decision is based on concerns regarding participant privacy and confidentiality, as well as the sensitive nature of the collected information. Therefore, the study's data will only be accessible to the research team and authorised personnel involved in the project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An integrated online program in people with Stress Disorders, Post-Traumatic, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stanley Kam Ki Lam, PhD ((852)39439932, stanleylam@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-traumatic Stress Disorder (PTSD) symptom severity (time frame: The outcome will be measured at baseline (T0) and immediately post-intervention (T1).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.