The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents

NCT07325734 | Recruiting

• 1 other identifier: Group GWE for Adolescent CPTSD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

CPTSD, Compelx Post-traumatic Stress Disorder

Keywords

adolescents; randomized controlled trial; Complex PTSD

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)

Study Arms (2)

GWE-C

EXPERIMENTAL

Behavioral: Group Guided Written Exposure Therapy for CPTSD (GWE-C)

Supportive group

ACTIVE COMPARATOR

Behavioral: Supportive Group

Interventions

Group Guided Written Exposure Therapy for CPTSD (GWE-C) BEHAVIORAL

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.

GWE-C

Supportive Group BEHAVIORAL

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.

Supportive group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (2)

Changchun middle school

Fuyang, Anhui, China

RECRUITING

Peking University

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Yinyin Zang, Ph.D.

CONTACT

00861062756953; yinyin.zang@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomization will be conducted by an independent research assistant, and the random sequence will be concealed from the investigators until the process is completed. Outcome assessors will be blinded to participants' treatment conditions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 8, 2026
• Study Start: October 10, 2025
• Primary Completion (Estimated): October 10, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: January 8, 2026

Record last verified: 2025-10

Locations

CN (2)