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Recruiting NCT07325734

The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents

No phase Interventional CPTSD, Compelx Post-traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group Guided Written Exposure Therapy for CPTSD (GWE-C), Supportive Group.
Who it may be relevant to
Registry conditions: CPTSD, Compelx Post-traumatic Stress Disorder. Basic parameters: 10 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Effectiveness of Guided Written Exposure Therapy for Complex PTSD in Adolescents: A Multicenter Randomized Controlled Trial

Overview

This study aims to examine the effectiveness of group Guided Written Exposure Therapy for Complex Post-Traumatic Stress Disorder (GWE-C) among Chinese adolescents through a randomized controlled trial. A total of 120 participants will be recruited, with 60 randomized to the GWE-C group and 60 randomized to the supportive therapy (ST) group. The GWE-C intervention will consist of 7 to 10 group sessions. The primary outcome, assessed by the International Trauma Questionnaire (ITQ), will be measured at baseline, post-treatment, 1-month follow-up, and 3-month follow-up.

Interventions

  • Behavioral Group Guided Written Exposure Therapy for CPTSD (GWE-C)
    Group Guided Written Exposure Therapy for CPTSD (GWE-C) is a manualized, exposure-based therapeutic program consisting of 7 to 10 sequential sessions. The intervention follows a structured sequence of trauma processing that addresses trauma details, associated emotions, cognitions, and impacts. Writing tasks incorporate imagery dialogues, self-compassion exercises, and resource identification to help participants alleviate C-PTSD symptoms. The interval between two consecutive sessions ranges fr
  • Behavioral Supportive Group
    Supportive group, the comparator intervention, is a non-trauma-focused treatment based on the Rogerian psychotherapy model and has been used as an active comparator in previous trials of trauma-focused therapies. The program comprises seven sessions: the first two employ group activities such as card games and interactive drawing to build a sense of belonging; sessions three to six focus on stress management and emotion regulation skills through methods including expressive drawing, relaxation t

Primary outcome measures

  • CPTSD Symptom Severity (self-report) [Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)]
  • CPTSD Symptom Severity (interview) [Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)]
Secondary outcome measures (4)
  • PTSD Checklist-5 (PCL-5) [Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)]
  • Patient Health Questionnaire 9-item [Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)]
  • Generalized Anxiety Disorder 7-item [Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)]
  • The Strengths and Difficulties Questionnaire [Time frame: baseline(week 0), post treatment (week 3), 1-month follow-up (week 7), 3-month follow-up (week 15)]

Eligibility criteria

Inclusion criteria

  • Aged between 10 and 18 years;
  • Meet the diagnostic or subclinical criteria for Complex PTSD (C-PTSD), defined as missing at most one symptom from either the PTSD or DSO clusters;
  • Possess sufficient literacy and language skills to complete writing-based tasks;
  • Be able to understand the study procedures and complete the required assessments;
  • Provide written informed consent, with consent also obtained from their legal guardians.

Exclusion criteria

  • Presence of a severe psychiatric disorder or neurodevelopmental disorder, such as schizophrenia, bipolar I disorder, autism spectrum disorder, intellectual disability, or other severe psychiatric conditions that would interfere with study participation;
  • Presence of a severe physical illness that would impair the ability to engage in the intervention;
  • Assessed as being at high suicidal risk (e.g., current suicidal ideation with intent or plan, recent suicide attempt within the past 12 months, or severe self-harm behaviors);
  • Ongoing exposure to traumatic events;
  • Currently receiving other trauma-focused psychological treatments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Changchun middle school — Fuyang
  • Peking University — Beijing

Identifiers

NCT: NCT07325734 · Group GWE for Adolescent CPTSD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗