The Effectiveness of Group-Delivered Revised Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents

Not Applicable

Recruiting

• Conditions: PTSD
• Interventions: Behavioral: Group-delivered guided written exposure therapy-revised version; Behavioral: Waiting-List (WL) condition

• Registration Number: NCT06390293
• Lead Sponsor: Peking University

Brief Summary

The study aims to examine the effectiveness of the group-delivered revised written exposure therapy (WET-R) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 70 participants, with 35 randomized to the WET-R group and 35 randomized to the waiting list (WL) group. The WET-R intervention consists of 5-8 group sessions. The primary outcome CPSS-5-I (Child PTSD Symptom Scale-Interview Version for DSM-5) and PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up, and 6-month follow-up assessments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-28
• Last Update Submitted: 2024-04-28
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30
• Study Start: 2024-05-01
• Primary Completion: 2025-02-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Adolescents aged 10-18 years.
2. 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).
3. If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
4. Capable of writing and understanding written instructions.

Exclusion Criteria

1. Presence of severe psychopathology necessitating immediate medical attention
2. Moderate to high suicide risk (e.g., intent or plan to attempt suicide in the near future
3. Evidence of a moderate or severe traumatic brain injury
4. Currently undergoing psychotherapy specifically for PTSD.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group guided WET-R	Group-delivered guided written exposure therapy-revised version	-
Waiting-List (WL) condition	Waiting-List (WL) condition	-

Primary Outcome Measures

Name	Time	Method
PTSD Checklist-5 (PCL-5)	baseline,post treatment(2 weeks), 6 weeks, 14 weeks, 26 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 children.
Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I)	baseline,post treatment(2 weeks), 6 weeks, 14 weeks，26 weeks	The PTSD Symptom Scale, CPSS-5-I is a 27-item semi-structured interview that assesses PTSD DSM-5 diagnosis and symptom severity in the past month based on interviewer ratings. The CPSS-5-I assesses history of Criterion A traumatic experiences to identify an index trauma.The 20 items assessing DSM-5 PTSD symptoms are presented. The interviewer rates each item from 0 (not at all) to 4 (6 or more times a week/almost always) based on the frequency and severity of the reported symptom experienced in the past month related to the index trauma. Finally, seven items assess impairment of endorsed symptoms on daily functioning pertinent to youth. The interviewer rates these items on a scale of 0 (not at all) to 4( 6 or more times a week/almost always).The total impairment score does not contribute to the overall severity score.CPSS-5-I has demonstrated excellent reliability and validity .

Trial Locations

Locations (1)

Peking University; 🇨🇳 Peking, Beijing, China