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Completed

NCT Number: NCT06403449

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

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jishishan County Resettlement Middle School

Linxia, Gansu, 731700, 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) 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.

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

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.

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.

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 adolescents.

  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-item

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

    Patient Health Questionnaire 9-item (PHQ-9), a self-report measure for depressive symptoms in past two weeks, comprises 9 items rated from 0 (not at all) to 3 (nearly every day). The PHQ-9 has good psychometric properties in Chinese adolescents.

  2. Generalized Anxiety Disorder 7-item

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

    Generalized Anxiety Disorder 7-item (GAD-7) scale is a 7- item self-report measure assess anxiety symptoms in past two weeks. Each item is rated from 0 (not at all) to 3 (nearly every day).The Chinese version GAD-7 score has good psychometric properties among adolescents.

  3. The Strengths and Difficulties Questionnaire

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

    The Strengths and Difficulties Questionnaire (SDQ) is a 25-item self-report questionnaire assessing emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour .The response scale ranges from 0 ( not true) to 2 (certainly true). Chinese version has been demonstrated to have good internal consistency.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 7, 2024
Registry last updated
Jul 28, 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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