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NCT Number: NCT06390293

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University

Beijing, Beijing Municipality, 100871, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Group-delivered guided written exposure therapy

Behavioral

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.

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 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.

Primary outcomes

  1. PTSD Checklist-5 (PCL-5)

    Time frame: 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 children.

  2. CPTSD symptoms

    Time frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks

    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.

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks

    Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure of depression severity over the preceding two weeks. Items are rated on a 4-point scale (0 = not at all to 3 = nearly every day), yielding total scores from 0 to 27. The Chinese version has demonstrated good psychometric properties in adolescents.

  2. Generalized Anxiety Disorder 7-item scale

    Time frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks

    Generalized Anxiety Disorder 7-item scale (GAD-7), evaluates symptom severity over the preceding two weeks. Items are rated on a 4-point scale (0 = not at all to 3 = nearly every day), yielding total scores from 0 to 21. The Chinese version has demonstrated robust psychometric properties in adolescent samples.

  3. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: baseline,post treatment(2 weeks), 6 weeks, 14 weeks

    Strengths and Difficulties Questionnaire (SDQ), a 25-item self-report measure covering five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Items are rated on a 3-point scale (0 = not true to 2 = certainly true). A total difficulties score was computed by summing the four problem subscales and the reverse-scored prosocial subscale, yielding scores from 0 to 50.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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