The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD Among Chinese Adolescents

March 19, 2026 updated by: Yinyin Zang, PhD, Peking University

The Effectiveness of Group-Delivered Written Exposure Therapy for PTSD and Complex PTSD Among Chinese Adolescents: A Pilot Randomized Controlled Trial

The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 50 participants, with 25 randomized to the GWE group and 25 randomized to the waiting list (WL) group. The GWE intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) and ITQ-CA (International Trauma Questionnaire-Child and Adolescent Version) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100871
        • Peking University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Adolescents aged 10-18 years.
  2. Meeting full or subthreshold PTSD (up to one symptom missing).
  3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
  4. Capable of writing and understanding written instructions.

Exclusion Criteria:

  1. Presence of severe psychopathology necessitating immediate medical attention
  2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future
  3. Evidence of a moderate or severe traumatic brain injury
  4. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Waiting-List (WL) condition
Behavioral: 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 2-week WL period. After the one-month follow-up of the WET-R group, they will receive the same treatment (Group-Delivered guided written exposure therapy-revised version).WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.
Experimental: Group-delivered guided written exposure therapy
Behavioral: Group-delivered guided written exposure therapy
guided written exposure therapy 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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 children.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depression severity over the preceding two weeks. Items are rated on a 4-point scale (0 = not at all to 3 = nearly every day), yielding total scores from 0 to 27. The Chinese version has demonstrated good psychometric properties in adolescents.
baseline,post treatment(2 weeks), 6 weeks, 14 weeks
Generalized Anxiety Disorder 7-item scale
Time Frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
Generalized Anxiety Disorder 7-item scale (GAD-7), evaluates symptom severity over the preceding two weeks. Items are rated on a 4-point scale (0 = not at all to 3 = nearly every day), yielding total scores from 0 to 21. The Chinese version has demonstrated robust psychometric properties in adolescent samples.
baseline,post treatment(2 weeks), 6 weeks, 14 weeks
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
Strengths and Difficulties Questionnaire (SDQ), a 25-item self-report measure covering five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items are rated on a 3-point scale (0 = not true to 2 = certainly true). A total difficulties score was computed by summing the four problem subscales and the reverse-scored prosocial subscale, yielding scores from 0 to 50.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GWE on adolescents

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

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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