- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06403449
The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD Among Adolescents : A Pilot Study
April 19, 2026 updated by: Yinyin Zang, PhD, Peking University
The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD Among Chinese Adolescents: A Pilot Randomized Controlled Trial
The study aims to examine the effectiveness of group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD in Chinese adolescents through a randomized controlled trial.
A total of 50 participants will be recruited, with 25 randomized to the GWE group and 25 to the waiting-list (WL) group.
The GWE intervention will consist of 5 to 8 group sessions.
The primary outcome, PTSD and CPTSD symptom severity, will be assessed at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
53
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
-
-
Beijing Municipality
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Beijing, Beijing Municipality, China, 100871
- Peking University
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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
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adolescents aged 10-18 years.
- Meeting full or subthreshold PTSD (up to one symptom missing) diagnostic criteria according to the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I).
- If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
- Capable of writing and understanding written instructions.
Exclusion Criteria:
- Presence of severe psychopathology necessitating immediate medical attention
- Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future)
- Evidence of a moderate or severe traumatic brain injury
- Currently undergoing psychotherapy specifically for PTSD.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Waiting-List (WL) condition
|
Participants assigned to WL will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the waitting period.
After the one-month follow-up of the GWE group, they will receive the same treatment.WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.
|
|
Experimental: GWE
|
Group-Delivered guided written exposure therapy (GWE) is a manualized exposure-based therapy program consisting of 5-8 sequential sessions.
The interval between every 2 consecutive sessions is 0-2 days.
There will be 5-8 group-delivered sessions in total (only one index trauma will be discussed), and 1-2 weeks to complete.The first and last sessions are scheduled to last for 1.5 hours each, while the other sessions will be 50 minutes in duration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Checklist-5 (PCL-5)
Time Frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
PCL-5 was a 20-item self-report scale that assesses PTSD DSM-5 diagnosis and symptom severity in the past month.
Items were rated on a 5-point Likert scale from 0 ("not at all") to 4("extremely").The Chinese version of PCL-5 has shown good psychometric properties in trauma-affected Chinese adolescents.
|
baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
|
CPTSD symptoms
Time Frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
|
CPTSD symptoms include two parts: PTSD symptoms were assessed using six PCL-5 items mapped to ICD-11 domains: re-experiencing (items 2 and 3), avoidance (items 6 and 7), and sense of current threat (items 17 and 18).
Disturbances in self-organization (DSO) were measured using the 6-item DSO subscale of the International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA), which has demonstrated good validity in Chinese adolescent samples.
The resulting 12-item composite yielded total scores ranging from 0 to 48, consistent with ITQ-CA scoring conventions.
|
baseline,post treatment(2 weeks), 6 weeks, 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Health Questionnaire 9-item
Time Frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
Patient Health Questionnaire 9-item (PHQ-9), a self-report measure for depressive symptoms in past two weeks, comprises 9 items rated from 0 (not at all) to 3 (nearly every day).
The PHQ-9 has good psychometric properties in Chinese adolescents.
|
baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
|
Generalized Anxiety Disorder 7-item
Time Frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
Generalized Anxiety Disorder 7-item (GAD-7) scale is a 7- item self-report measure assess anxiety symptoms in past two weeks.
Each item is rated from 0 (not at all) to 3 (nearly every day).The Chinese version GAD-7 score has good psychometric properties among adolescents.
|
baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
|
The Strengths and Difficulties Questionnaire
Time Frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report questionnaire assessing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour .The response scale ranges from 0 ( not true) to 2 (certainly true).
Chinese version has been demonstrated to have good internal consistency.
|
baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 10, 2024
Primary Completion (Actual)
October 15, 2024
Study Completion (Actual)
October 15, 2024
Study Registration Dates
First Submitted
May 3, 2024
First Submitted That Met QC Criteria
May 3, 2024
First Posted (Actual)
May 7, 2024
Study Record Updates
Last Update Posted (Actual)
April 23, 2026
Last Update Submitted That Met QC Criteria
April 19, 2026
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G-WET on Adolescents PTSD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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