CPTSD, Compelx Post-traumatic Stress DisorderNCT07325734
The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents
A study testing Group Guided Written Exposure Therapy for CPTSD (GWE-C) and Supportive Group in people with CPTSD, Compelx Post-traumatic Stress Disorder, run by Peking University at 4 sites in China.
Trial summary
This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among 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
- CPTSD, Compelx Post-traumatic Stress Disorder
- What is being tested?
- Group Guided Written Exposure Therapy for CPTSD (GWE-C) and Supportive Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 4 sitesChina
- Study dates
- 10 Oct 2025to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged between 10 and 18 years;
- Meet the diagnostic or subclinical criteria for Complex PTSD (C-PTSD), defined as missing at most one symptom from either the PTSD or DSO clusters;
- Possess sufficient literacy and language skills to complete writing-based tasks;
- Be able to understand the study procedures and complete the required assessments;
- Provide written informed consent, with consent also obtained from their legal guardians.
Who cannot join
- Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
- Presence of a severe physical illness that would impair the ability to engage in the intervention;
- Assessed as being at high suicidal risk (e.g., current suicidal ideation with intent or plan, recent suicide attempt within the past 12 months, or severe self-harm behaviors);
- Ongoing exposure to traumatic events;
- Currently receiving other trauma-focused psychological treatments.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 1 recruiting
- Recruiting
Peking University
Beijing, Beijing Municipality
Yinyin Zang, phd, +86 15553201610, yinyin.zang@pku.edu.cn
- Completed
Changchun middle school
Fuyang, Anhui
- Completed
Ulanhot No. 1 High School
Ulanhot, Inner Mongolia, 137400
- Completed
Urumqi No. 74 Middle School
Ürümqi, Xinjiang, 830000
About this study
Official title: The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents: A Multicenter Randomized Controlled Trial
This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.
- Being tested
- Group Guided Written Exposure Therapy for CPTSD (GWE-C), Supportive Group
- Keywords
- adolescents, randomized controlled trial, Complex PTSD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Guided Written Exposure Therapy for CPTSD (GWE-C)Behavioural
Group Guided Written Exposure Therapy for CPTSD (GWE-C) is a manualized, exposure-based therapeutic program consisting of 7 to 10 sequential sessions. The intervention follows a structured sequence of trauma processing that addresses trauma details, associated emotions, cognitions, and impacts. Writing tasks incorporate imagery dialogues, self-compassion exercises, and resource identification to help participants alleviate C-PTSD symptoms.
The interval between two consecutive sessions ranges from 0 to 2 days, with participants expected to complete all sessions within 1 to 2 weeks. The first and last sessions are scheduled to last 1.5 hours each, while the intermediate sessions are 60 minutes in duration. Each group will consist of 6 to 10 participants and will be facilitated by one counselor and one assistant.
Supportive GroupBehavioural
Supportive group, the comparator intervention, is a non-trauma-focused treatment based on the Rogerian psychotherapy model and has been used as an active comparator in previous trials of trauma-focused therapies. The program comprises seven sessions: the first two employ group activities such as card games and interactive drawing to build a sense of belonging; sessions three to six focus on stress management and emotion regulation skills through methods including expressive drawing, relaxation training, and resource identification; the final session emphasizes reflection and sharing. Throughout, counsellors provide supportive guidance to encourage emotional expression, mutual listening, and peer support, while discussions deliberately exclude participants' individual traumatic experiences.
| Study group | Role | What they receive |
|---|---|---|
| GWE-C | Experimental | Not described Receives: Behavioral: Group Guided Written Exposure Therapy for CPTSD (GWE-C) |
| Supportive group | Active comparator | Not described Receives: Behavioral: Supportive Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPTSD Symptom Severity (self-report)
International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA ) is a self-report measure that assesses ICD-11 PTSD and CPTSD. The measure includes 6 core items of PTSD symptom clusters (ie. re-experiencing, avoidance, sense of threat), 6 core items of Disturbances in Self-Organization (DSO) clusters (ie affective dysregulation, negative self-concept, disturbed relationships). Each item is rated from 0(not at all) to 4(extremely). The Chinese version has been demonstrated good psychometric properties (Ho et al., 2022).
Measured: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
CPTSD Symptom Severity (interview)
The Child CPTSD Symptom Interview (CCSI) is a 12-item semi-structured interview developed by adapting items from the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I) and the International Trauma Interview (ITI).The PTSD section of the CCSI includes two items for each of the three PTSD symptom clusters, following the structure of the CPSS-5-I: re-experiencing (Re), characterized by flashbacks or nightmares; avoidance (Av), referring to avoidance of internal or external reminders of the traumatic event; and a sense of current threat (Th), expressed through hypervigilance or exaggerated startle reactions.The second part assesses Disturbances in Self-Organization (DSO) symptoms, based on the structure of the ITI , with two items per DSO symptom cluster.
Measured: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Secondary outcomes (4)
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
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(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start10 Oct 2025
- Primary completion25 Nov 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CPTSD, Compelx Post-traumatic Stress DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
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
- NCT07325734
- Sponsor's protocol ID
- Group GWE for Adolescent CPTSD
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2025
- Last updated
- 2 Sep 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 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07325734
- Acronym / sponsor ID
- Group GWE for Adolescent CPTSD
- Keywords
- adolescents, randomized controlled trial, Complex PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 25 Nov 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 8 Jan 2026 (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.
This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured 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
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GWE-C | Experimental | Behavioral: Group Guided Written Exposure Therapy for CPTSD (GWE-C) |
| Supportive group | Active comparator | Behavioral: Supportive Group |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Aged between 10 and 18 years;
- Meet the diagnostic or subclinical criteria for Complex PTSD (C-PTSD), defined as missing at most one symptom from either the PTSD or DSO clusters;
- Possess sufficient literacy and language skills to complete writing-based tasks;
- Be able to understand the study procedures and complete the required assessments;
- Provide written informed consent, with consent also obtained from their legal guardians.
Key exclusion criteria (5 listed)
- Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
- Presence of a severe physical illness that would impair the ability to engage in the intervention;
- Assessed as being at high suicidal risk (e.g., current suicidal ideation with intent or plan, recent suicide attempt within the past 12 months, or severe self-harm behaviors);
- Ongoing exposure to traumatic events;
- Currently receiving other trauma-focused psychological treatments.
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 Guided Written Exposure Therapy for CPTSD (GWE-C)Group Guided Written Exposure Therapy for CPTSD (GWE-C) is a manualized, exposure-based therapeutic program consisting of 7 to 10 sequential sessions. The intervention follows a structured sequence of trauma processing that addresses trauma details, associated emotions, cognitions, and impacts. Writing tasks incorporate imagery dialogues, self-compassion exercises, and resource identification to help participants alleviate C-PTSD symptoms. The interval between two consecutive sessions ranges from 0 to 2 days, with participants expected to complete all sessions within 1 to 2 weeks. The first and last sessions are scheduled to last 1.5 hours each, while the intermediate sessions are 60 minutes in duration. Each group will consist of 6 to 10 participants and will be facilitated by one counselor and one assistant. | Behavioural | GWE-C |
| Supportive GroupSupportive group, the comparator intervention, is a non-trauma-focused treatment based on the Rogerian psychotherapy model and has been used as an active comparator in previous trials of trauma-focused therapies. The program comprises seven sessions: the first two employ group activities such as card games and interactive drawing to build a sense of belonging; sessions three to six focus on stress management and emotion regulation skills through methods including expressive drawing, relaxation training, and resource identification; the final session emphasizes reflection and sharing. Throughout, counsellors provide supportive guidance to encourage emotional expression, mutual listening, and peer support, while discussions deliberately exclude participants' individual traumatic experiences. | Behavioural | Supportive group |
Primary outcome
CPTSD Symptom Severity (self-report)
Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA ) is a self-report measure that assesses ICD-11 PTSD and CPTSD. The measure includes 6 core items of PTSD symptom clusters (ie. re-experiencing, avoidance, sense of threat), 6 core items of Disturbances in Self-Organization (DSO) clusters (ie affective dysregulation, negative self-concept, disturbed relationships). Each item is rated from 0(not at all) to 4(extremely). The Chinese version has been demonstrated good psychometric properties (Ho et al., 2022).
CPTSD Symptom Severity (interview)
Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
The Child CPTSD Symptom Interview (CCSI) is a 12-item semi-structured interview developed by adapting items from the Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I) and the International Trauma Interview (ITI).The PTSD section of the CCSI includes two items for each of the three PTSD symptom clusters, following the structure of the CPSS-5-I: re-experiencing (Re), characterized by flashbacks or nightmares; avoidance (Av), referring to avoidance of internal or external reminders of the traumatic event; and a sense of current threat (Th), expressed through hypervigilance or exaggerated startle reactions.The second part assesses Disturbances in Self-Organization (DSO) symptoms, based on the structure of the ITI , with two items per DSO symptom cluster.
4 secondary outcomes
PTSD Checklist-5 (PCL-5)
Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Patient Health Questionnaire 9-item
Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Generalized Anxiety Disorder 7-item
Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
The Strengths and Difficulties Questionnaire
Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for CPTSD, Compelx Post-traumatic Stress Disorder
Recruiting
The Effectiveness of Group Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents
CPTSD, Compelx Post-traumatic Stress Disorder
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Guided Written Exposure Therapy for CPTSD (GWE-C) and Supportive Group in people with CPTSD, Compelx Post-traumatic Stress Disorder, run by Peking University at 4 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yinyin Zang, Ph.D. (00861062756953, yinyin.zang@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPTSD Symptom Severity (self-report) (time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)). 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 2 Sep 2026.