NCT06390293

Brief Summary

The study aims to examine the effectiveness of the group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD among Chinese adolescents with a randomized controlled trial. The study will recruit 50 participants, with 25 randomized to the GWE group and 25 randomized to the waiting list (WL) group. The GWE intervention consists of 5-8 group sessions. The primary outcome PCL-5 ( PTSD Checklist-5) and ITQ-CA (International Trauma Questionnaire-Child and Adolescent Version) will be administered on baseline, post-treatment, 1-month follow-up, 3-month follow-up assessments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

April 23, 2024

Last Update Submit

March 19, 2026

Conditions

Keywords

PTSDwritten exposure therapyrandomized controlled trialadolescents

Outcome Measures

Primary Outcomes (2)

  • 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

  • CPTSD symptoms

    CPTSD symptoms include two parts: PTSD symptoms were assessed using six PCL-5 items mapped to ICD-11 domains: re-experiencing (items 2 and 3), avoidance (items 6 and 7), and sense of current threat (items 17 and 18). Disturbances in self-organization (DSO) were measured using the 6-item DSO subscale of the International Trauma Questionnaire-Child and Adolescent Version (ITQ-CA), which has demonstrated good validity in Chinese adolescent samples. The resulting 12-item composite yielded total scores ranging from 0 to 48, consistent with ITQ-CA scoring conventions.

    baseline,post treatment(2 weeks), 6 weeks, 14 weeks

Secondary Outcomes (3)

  • Patient Health Questionnaire-9 (PHQ-9)

    baseline,post treatment(2 weeks), 6 weeks, 14 weeks

  • Generalized Anxiety Disorder 7-item scale

    baseline,post treatment(2 weeks), 6 weeks, 14 weeks

  • Strengths and Difficulties Questionnaire (SDQ)

    baseline,post treatment(2 weeks), 6 weeks, 14 weeks

Study Arms (2)

Group-delivered guided written exposure therapy

EXPERIMENTAL
Behavioral: Group-delivered guided written exposure therapy

Waiting-List (WL) condition

OTHER
Behavioral: Waiting-List (WL) condition

Interventions

guided written exposure therapy 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.

Group-delivered guided written exposure therapy

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.

Waiting-List (WL) condition

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged 10-18 years.
  • Meeting full or subthreshold PTSD (up to one symptom missing).
  • If taking psychotropic medication, currently stabilized on psychotropic medication for at least four weeks.
  • Capable of writing and understanding written instructions.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

April 23, 2024

First Posted

April 30, 2024

Study Start

May 1, 2024

Primary Completion

February 1, 2025

Study Completion

June 1, 2025

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations