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Набор скоро начнётся NCT07563556

Mind-Body Intervention in Earthquake Survivors: 6 mo RCT

Без фазы С лечением Earthquake Victim

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: combined mind-body intervention, Routine Care and Follow-up Phone Calls.
Кому может быть актуально
Состояния в реестре: Earthquake Victim. Базовые параметры: 18 лет — 65 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
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Examining the Effect of Combined Mind-body Intervention in Earthquake Survivors: A 6 Months Follow-up Randomized Controlled Trial

Обзор

The purpose of this study is to investigate whether a 4-week program called "Combined Mind-Body Intervention" can help survivors of the February 6, 2023, earthquakes manage stress and improve their ability to participate in daily activities. The study specifically aims to answer the following question: Does a program combining guided imagery and progressive muscle relaxation lead to significant, long-term improvements in occupational performance (self-care, work, and leisure), reduced stress levels, and better overall quality of life for earthquake survivors when compared to a control group? The study will involve: Target Population: Adults aged 18 to 65 who directly experienced the 2023 earthquakes and currently reside in the affected region .Intervention: Participants in the intervention group will attend eight individual sessions (twice a week) focusing on deep breathing, step-by-step muscle relaxation, and guided visualization of peaceful environments. Evaluation: Changes in stress, mood, and daily activity performance will be measured at the beginning of the study, at the end of the 4-week program, and during a 6-month follow-up period to determine the lasting effects of the intervention.

Вмешательства

  • Другое combined mind-body intervention
    The intervention consists of 8 individual sessions (30-40 mins, twice weekly) combining Jacobson's Progressive Muscle Relaxation (PMR) and Guided Imagery. Sessions begin with 5 minutes of diaphragmatic breathing. PMR involves 15 minutes of tensing and relaxing specific muscle groups (limbs, face, trunk) to reduce physical tension. This is followed by 15 minutes of Guided Imagery, visualizing sensory-rich "safe places" (e.g., childhood gardens) to promote emotional regulation. Participants perfor
  • Поведенческое Routine Care and Follow-up Phone Calls
    Participants receive their standard routine care. Additionally, they will be contacted by phone twice a week for 4 weeks by the primary investigator to inquire about their general health and well-being. These calls are limited to status inquiries to ensure that any observed changes in the study are due to the intervention itself rather than the attention provided by the researcher.

Первичные конечные точки

  • Canadian Occupational Performance Measure (COPM) - Performance and Satisfaction Scores [Срок оценки: Baseline, at the end of the 4-week intervention, and at the 6-month follow-up.]
Вторичные конечные точки (3)
  • Hospital Anxiety and Depression Scale - Anxiety Sub-scale (HADS-A) [Срок оценки: Baseline, Week 4, and Month 6.]
  • Hospital Anxiety and Depression Scale - Depression Sub-scale (HADS-D) [Срок оценки: Baseline, Week 4, and Month 6.]
  • Nottingham Health Profile (NHP) Domain Scores [Срок оценки: Baseline, Week 4, and Month 6.]

Критерии участия

Критерии включения

  • Being between 18 and 65 years old.
  • Having directly experienced the February 6, 2023 earthquake.
  • Currently residing in the earthquake zone.
  • Possessing sufficient cognitive and language skills to participate in assessments and the intervention.

Критерии исключения

  • Having an additional psychiatric or neurological disease diagnosis.
  • Having received non-pharmacological interventions (such as psychotherapy, CBT, art therapy, or meditation) before or during the study.
  • Currently using psychiatric medications.
  • Having a history of other physical (e.g., violence) or psychological trauma.
  • Being pregnant or currently breastfeeding.
  • Having a current substance addiction.
  • Demonstrating suicidal tendencies.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Hacettepe University — Ankara

Идентификаторы

NCT: NCT07563556 · 2026-231

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗