- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06931093
The Effectiveness of Group Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents
The Effectiveness of Group Guided Written Exposure Therapy for CPTSD Symptoms Among Adolescents : A Multi-centered Randomized Controlled Trail
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yinyin Zang, Ph.D.
- Phone Number: 00861062756953
- Email: yinyin.zang@pku.edu.cn
Study Locations
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, China, 100871
- Recruiting
- Peking University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 10 and 18 years;
- Meet the diagnostic or subclinical criteria for Complex PTSD (C-PTSD), defined as the presence of at least one positive symptom in each of the PTSD symptom clusters, along with at least one positive symptom in each of the Disturbance in Self-Organization (DSO) symptom 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.
Exclusion Criteria:
- 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;
- Suicidal ideation within the past six months;
- Ongoing exposure to traumatic events;
- Currently receiving other trauma-focused psychological treatments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
|
Active Comparator: Supportive counselling treatment group (ST)
|
Supportive counselling, 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CPTSD Symptom Severity (self-report)
Time Frame: baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA; Cloitre et al.,2018 ) 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).
|
baseline, post treatment(2 weeks), 6 weeks, 14 weeks
|
|
CPTSD Symptom Severity(interview)
Time Frame: baseline, post treatment(2 weeks), 6 weeks, 14weeks
|
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 (Roberts et al., 2019), with two items per DSO symptom cluster.
|
baseline, post treatment(2 weeks), 6 weeks, 14weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GWE-C on Adolescents CPTSD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on CPTSD, Compelx Post-traumatic Stress Disorder
-
Peking UniversityRecruitingCPTSD, Compelx Post-traumatic Stress DisorderChina
-
Istanbul UniversityRecruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD)Turkey
-
Istanbul UniversityRecruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD)Turkey
-
University of ZurichCompletedPost Traumatic Stress Disorder (PTSD) | Complex Post-Traumatic Stress Disorder (CPTSD)Switzerland
-
University Hospital, Strasbourg, FranceNot yet recruitingComplex Post-Traumatic Stress Disorder (CPTSD) | Post-traumatic Stress Disorder (PTSD) | Borderline Personality Disorder (BPD)
-
Ciusss de L'Est de l'Île de MontréalCompletedComplex Post-Traumatic Stress Disorder (CPTSD) | Borderline Personality Disorder (BPD) | Post-Traumatic Stress Disorder, PTSDCanada
-
Acacia ClinicsElectroCore INC; Vagus Nerve SocietyRecruitingPTSD | Post Traumatic Stress Disorder | Post Traumatic Stress Disorders | Post-traumatic Stress Disorder (PTSD) | Post Traumatic Stress Disorder PTSD | PTSD - Post Traumatic Stress Disorder | Post-Traumatic Stress Disorder, PTSDUnited States
-
University of LuxembourgQuresta, Inc.; National Psychological Association of Ukraine; Veteran Mental...RecruitingPost Traumatic Stress Disorder | Post Traumatic Stress Disorder PTSD | Post-Traumatic Stress Disorder, PTSDUkraine
-
University of California, Los AngelesDefense Advanced Research Projects Agency; Defense Group, Inc.CompletedPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder, ChronicUnited States
-
University of California, Los AngelesWithdrawnPost-traumatic Stress Disorder | Post-Traumatic Stress Disorder in ChildrenUnited States
Clinical Trials on Group Guided Written Exposure Therapy for CPTSD (GWE-C)
-
Peking UniversityRecruitingCPTSD, Compelx Post-traumatic Stress DisorderChina
-
St. Joseph's Healthcare HamiltonRecruitingPosttraumatic Stress DisorderCanada
-
St. Joseph's Healthcare HamiltonNot yet recruitingPosttraumatic Stress Disorder (PTSD) | Borderline Personality Disorder (BPD)Canada
-
Boston VA Research Institute, Inc.United States Department of Defense; University of TexasCompleted
-
Stanford UniversityNational Center for Complementary and Integrative Health (NCCIH); University...RecruitingPostpartum Care | Written Exposure Therapy | PTSD (Childbirth-Related) | Breathing TechniquesUnited States
-
Peking UniversityCompleted
-
Peking UniversityCompleted
-
Boston VA Research Institute, Inc.The University of Texas Health Science Center at San AntonioCompletedSuicide | Posttraumatic Stress DisorderUnited States
-
University of Colorado, BoulderRecruitingSocial Anxiety Disorder | Public Speaking Fear | Public Speaking Anxiety | Social FearUnited States
-
Palo Alto Veterans Institute for ResearchBoston University; The University of Texas Health Science Center at San Antonio and other collaboratorsCompletedInsomnia | Posttraumatic Stress Disorder | NightmareUnited States