- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325734
The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents
The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents: A Multicenter Randomized Controlled Trial
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
-
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Anhui
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Fuyang, Anhui, China
- Recruiting
- Changchun middle school
-
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Beijing Municipality
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Beijing, Beijing Municipality, China
- Recruiting
- Peking University
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Contact:
- Yinyin Zang, phd
- Phone Number: +86 15553201610
- Email: yinyin.zang@pku.edu.cn
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-
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 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.
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;
- 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.
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 group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
|
|
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.
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baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
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.
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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)
|
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.
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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)
|
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(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)
|
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.
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baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)
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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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Group GWE for Adolescent 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
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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