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

NCT ID: NCT06390293

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-01

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group guided WET-R

Group Type: EXPERIMENTAL

Group-delivered guided written exposure therapy-revised version

Intervention Type: BEHAVIORAL

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

Group Type: OTHER

Waiting-List (WL) condition

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Yinyin Zang

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yinyin Zang, PhD

Role: CONTACT

yinyin.zang@pku.edu.cn

+86 15553201610

Facility Contacts

Yinyin Zang, PhD

Role: primary

yinyin.zang@pku.edu.cn

+86-010-62756953

Other Identifiers

Guided WET-R on adolescents

Identifier Type: -

Identifier Source: org_study_id