PTSDNCT06403449
The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD Among Adolescents : A Pilot Study
A study testing Group-delivered guided written exposure therapy and Waiting-List (WL) condition in people with PTSD, run by Peking University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- PTSD
- What is being tested?
- Group-delivered guided written exposure therapy and Waiting-List (WL) condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2024to 15 Oct 2024
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- PTSD
- Being tested
- Group-delivered guided written exposure therapy, Waiting-List (WL) condition
- Keywords
- PTSD, adolescents, randomized controlled trial
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-delivered guided written exposure therapyBehavioural
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.
Waiting-List (WL) conditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GWE | Experimental | Not described Receives: Behavioral: Group-delivered guided written exposure therapy |
| Waiting-List (WL) condition | Other | Not described Receives: Behavioral: Waiting-List (WL) condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist-5 (PCL-5)
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.
Measured: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
CPTSD symptoms
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.
Measured: baseline,post treatment(2 weeks), 6 weeks, 14 weeks
Secondary outcomes (3)
Patient Health Questionnaire 9-item
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.
Measured: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Generalized Anxiety Disorder 7-item
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.
Measured: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
The Strengths and Difficulties Questionnaire
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.
Measured: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start10 May 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403449
- Sponsor's protocol ID
- G-WET on Adolescents PTSD
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and CPTSD Among Chinese Adolescents: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06403449
- Acronym / sponsor ID
- G-WET on Adolescents PTSD
- Conditions
- PTSD
- Keywords
- PTSD, adolescents, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 10 May 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 7 May 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GWE | Experimental | Behavioral: Group-delivered guided written exposure therapy |
| Waiting-List (WL) condition | Other | Behavioral: Waiting-List (WL) condition |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Group-delivered guided written exposure therapyGroup-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. | Behavioural | GWE |
| Waiting-List (WL) conditionParticipants 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. | Behavioural | Waiting-List (WL) condition |
Primary outcome
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.
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.
3 secondary outcomes
Patient Health Questionnaire 9-item
Time frame: 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
The Strengths and Difficulties Questionnaire
Time frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-delivered guided written exposure therapy and Waiting-List (WL) condition in people with PTSD, run by Peking University at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 28 Jul 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist-5 (PCL-5) (time frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks). The study lists 2 primary outcomes in all. 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 28 Jul 2026.