The Effectiveness of Group-Delivered Guided Written Exposure Therapy for PTSD and Subclinical PTSD Among Adolescents : a Pilot Study

Not Applicable

Completed

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

• Registration Number: NCT06403449
• Lead Sponsor: Peking University

Brief Summary

The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (G-WET) for post-traumatic stress disorder (PTSD) and subclinical PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 40 participants, with 20 randomized to the G-WET group and 20 randomized to the waiting list (WL) group. The G-WET intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-03
• Study First Submitted QC: 2024-05-03
• Study First Posted: 2024-05-07
• Study Start: 2024-05-10
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-15
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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
G-WET	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	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.

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire 9-item	baseline, post treatment(2 weeks), 6 weeks, 14 weeks	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.
Generalized Anxiety Disorder 7-item	baseline, post treatment(2 weeks), 6 weeks, 14 weeks	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.
The Strengths and Difficulties Questionnaire	baseline, post treatment(2 weeks), 6 weeks, 14 weeks	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.

Trial Locations

Locations (1)

Peking University; 🇨🇳 Beijing, Beijing, China