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Идёт набор NCT07325734

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

Без фазы С лечением CPTSD, Compelx Post-traumatic Stress Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group Guided Written Exposure Therapy for CPTSD (GWE-C), Supportive Group.
Кому может быть актуально
Состояния в реестре: CPTSD, Compelx Post-traumatic Stress Disorder. Базовые параметры: 10 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Поведенческое 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
  • Поведенческое 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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 2 центра
  • Changchun middle school — Fuyang
  • Peking University — Пекин

Идентификаторы

NCT: NCT07325734 · Group GWE for Adolescent CPTSD

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗