- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07589777
Trauma-Informed Yoga Intervention in Young Women
Trauma-Informed Yoga Intervention: A Randomized Controlled Trial on Psychological Trauma, Emotion Regulation, and Interoceptive Awareness in Young Adult Women
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
This study will be conducted with young adult women aged 18-25 residing in a selected province. Based on a G*Power analysis, the minimum required sample size was determined to be 46 participants (intervention: n = 23; control: n = 23). Participants will be randomly assigned to the intervention and control groups using a computer-generated simple randomization method (https://www.random.org/integers/
) to ensure unbiased allocation. The intervention group will be implemented in three separate groups, each consisting of 8-10 participants, and will receive the "Trauma-Informed Yoga Intervention Program," which includes eight sessions. Each session will last approximately 45 minutes, and two sessions will be conducted per week for each group. The program will consist of group-based yoga sessions structured in accordance with trauma-informed principles. Pretest and posttest measurements will be used to assess psychological trauma symptoms, difficulties in emotion regulation, and levels of interoceptive awareness among young women.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Duygu Özer, Asst. Prof
- Номер телефона: +905061291978
- Электронная почта: duyguozer2016@hotmail.com
Места учебы
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Bartın
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Bartın, Bartın, Турция (Туркие), 74100
- Bartın University
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Контакт:
- Duygu Özer
- Электронная почта: duyguozer@bartin.edu.tr
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Being a woman aged 18-25 years
- Providing voluntary written informed consent after being informed about the study
- Scoring within the highest 25th percentile on the Transmitted Psychological Trauma Scale based on the pre-screening assessment, indicating high levels of trauma-related symptoms
- Having no physical limitations that would prevent participation in weekly sessions and being medically eligible to engage in yoga practices
- Agreeing to comply with the study protocol, including attendance at intervention sessions and completion of all assessments
Exclusion Criteria:
- Inability to provide reliable responses due to the presence of active psychotic disorder, bipolar disorder, or severe cognitive impairment
- Being in an acute psychological crisis
- Initiation of intensive psychotherapy targeting trauma symptoms (e.g., trauma-focused therapy) within the past 3 months or participation in a similar structured psychosocial intervention during the study period
- Presence of serious musculoskeletal, cardiovascular, or neurological conditions or injuries that would prevent participation in yoga, or medical restriction of physical activity by a physician
- Having an established regular practice of yoga or meditation
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental
Participants in the intervention group received a trauma-informed, group-based yoga program consisting of eight sessions delivered twice weekly.
Each session lasted approximately 45 minutes and was conducted in accordance with trauma-informed principles.
|
Intervention program was applied to the intervention group in eight sessions online.
Each session will last an average of 45 minutes.
There will be two sessions for one group per week.
The intervention comprised eight sessions, including establishing a sense of safety and body awareness, listening to the body, integrating emotions and movement, safely engaging with past memories, fostering forgiveness and letting go, strengthening boundaries and personal empowerment, cultivating self-compassion and reconnection, and promoting integration and future orientation.
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Без вмешательства: Control
Participants in the control group received no structured intervention during the study period and only routine conditions were maintained.
Data were collected at the same time points as in the intervention group.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Transmitted Psychological Trauma Scale
Временное ограничение: Baseline, immediately post-intervention, and 1 month post-intervention
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The scale consists of 19 items and three subscales: family functioning (3 items), past family trauma (5 items), and emotion and behavior regulation (11 items).
Two items (items 3 and 5) in the scale are reverse scored.
Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Total scores range from 19 to 95, with higher scores indicating a greater likelihood of transmitted psychological trauma.
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Baseline, immediately post-intervention, and 1 month post-intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Difficulties in Emotion Regulation Scale - Short Form (DERS-16)
Временное ограничение: Baseline, immediately post-intervention, and 1 month post-intervention
|
The scale consists of 16 items and five subscales: clarity, goals, impulse, strategies, and non-acceptance.
The scale items are rated on a 5-point Likert scale, ranging from 1 (Almost never) to 5 (Almost always), with total scores ranging from 16 to 80. Higher scores indicate greater difficulty in emotion regulation.
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Baseline, immediately post-intervention, and 1 month post-intervention
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Multidimensional Assessment of Interoceptive Awareness - Version 2
Временное ограничение: Baseline, immediately post-intervention, and 1 month post-intervention
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The scale consists of 34 items rated on a 6-point Likert scale ranging from 0 (never) to 5 (always).
The number of items varies across the subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting.
Total scores on the scale range from 0 to 170.
The scale does not have an established cut-off point.
Higher scores indicate greater levels of interoceptive awareness.
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Baseline, immediately post-intervention, and 1 month post-intervention
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- BARU-SBF-DO-3
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .