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

NCT06403449 | Completed

• 1 other identifier: G-WET on Adolescents PTSD
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine the effectiveness of group-delivered guided written exposure therapy (GWE) for post-traumatic stress disorder (PTSD) and complex PTSD in Chinese adolescents through a randomized controlled trial. A total of 50 participants will be recruited, with 25 randomized to the GWE group and 25 to the waiting-list (WL) group. The GWE intervention will consist of 5 to 8 group sessions. The primary outcome, PTSD and CPTSD symptom severity, will be assessed at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.

Conditions

PTSD

Keywords

PTSD; adolescents; randomized controlled trial

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 adolescents.

  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-item

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

• Generalized Anxiety Disorder 7-item

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

• The Strengths and Difficulties Questionnaire

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

Study Arms (2)

GWE

EXPERIMENTAL

Behavioral: Group-delivered guided written exposure therapy

Waiting-List (WL) condition

OTHER

Behavioral: Waiting-List (WL) condition

Interventions

Waiting-List (WL) condition BEHAVIORAL

Participants assigned to WL will be asked to not work with other therapists or seek additional treatment for trauma-related difficulties during the waitting period. After the one-month follow-up of the GWE group, they will receive the same treatment.WL participants will also be given contact information to use in case of worsening symptoms or increasing distress.

Waiting-List (WL) condition

Group-delivered guided written exposure therapy BEHAVIORAL

Group-Delivered guided written exposure therapy (GWE) 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.

GWE

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged 10-18 years.
• 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).
• 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.

Sponsors & Collaborators

• Peking University: lead

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, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomization was conducted by an independent research assistant, and the random sequence was concealed from the investigator until the process was completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: May 10, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: April 23, 2026

Record last verified: 2024-05

Locations

CN (1)