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

PTSD Clinical Trial

Official title:

The Effectiveness of Group-Delivered Revised Written Exposure Therapy for PTSD and Subclinical PTSD Among Chinese Adolescents: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06390293
• Other study ID #: Guided WET-R on adolescents
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2024
• Source: Peking University
• Contact: Yinyin Zang, PhD
• Phone: +86 15553201610
• Email: yinyin.zang[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Group-delivered guided written exposure therapy-revised version
Group-Delivered guided WET-R is a manualized exposure-based therapy program consisting of 5-8 sequential sessions. The interval between every 2 consecutive sessions is 0-2 days. There will be 5-8 group-delivered sessions in total (only one index trauma will be discussed), and 1-2 weeks to complete. The first and last sessions are scheduled to last for 1.5 hours each, while the other sessions will be 50 minutes in duration.
• Waiting-List (WL) condition
Participants assigned to WL will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the 2-week WL period. After the one-month follow-up of the WET-R group, they will receive the same treatment (Group-Delivered guided written exposure therapy-revised version).WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.

Locations

Country	Name	City	State
China	Peking University	Peking	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Checklist-5 (PCL-5)	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.	baseline,post treatment(2 weeks), 6 weeks, 14 weeks, 26 weeks
Primary	Child PTSD Symptom Scale-Interview Version for DSM-5 (CPSS-5-I)	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 .	baseline,post treatment(2 weeks), 6 weeks, 14 weeks,26 weeks