Baduanjin Training for Depression and Anxiety Patients
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: Baduanjin, Health education.
- Кому может быть актуально
- Состояния в реестре: Depression Symptoms, Anxiety Symptoms. Базовые параметры: 18 лет — 70 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Effects of Baduanjin Breathing Training for Depression and Anxiety Patients: a Prospective Randomized Study
Обзор
In recent years, the number of people with symptoms of depression or anxiety are on the rise. The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung functions.
Подробное описание
Depression and anxiety, the two common mental health problems, are prevalent in the world. But there is a lack of sufficient no-drug intervention for relieving these two symptoms. The study focuses on mixed depressive and anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of depressive disorder or an anxiety disorder.
Baduanjin is a form of mind-body exercise with a profound philosophical foundation rooted in oriental culture. Previous studies have provided some evidences of beneficial effects on Baduanjin for depression and anxiety. Moreover, the effects and mechanisms of Baduanjin on patients with symptoms of depression and anxiety are yet to be further investigated.
This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 120 participants (60 for Baduanjin intervention group receiving health education plus a Baduanjin breathing training program, and 60 for health education control group only receiving health education).
The aims of the prospective randomized study are: (1) to examine the effects of Baduanjin breathing training on reducing symptoms of depression or anxiety, and (2) to explore the correlates between improvements of depression or anxiety symptom and changes of lung function.
Вмешательства
- Поведенческое Baduanjin
The Baduanjin training program consisted of two 90-min training classes and at least five 30-min at-home practice sessions per week for 16-weeks. All sessions included 10 min of warmup and 10 min of cooldown. - Поведенческое Health education
Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
Первичные конечные точки
- 17-item Hamilton Depression Rating Scale [Срок оценки: Change from Baseline HAMD-17 at 16 weeks]
- 14-item Hamilton Anxiety Rating Scale [Срок оценки: Change from Baseline HAMA-14 at 16 weeks]
Вторичные конечные точки (9)
- Depression, Anxiety and Stress Scale-21 item [Срок оценки: Change from Baseline DASS-21 at 8 weeks]
- Depression, Anxiety and Stress Scale-21 item [Срок оценки: Change from 8 weeks DASS-21 at 16 weeks]
- Vital capacity [Срок оценки: Change from Baseline VC at 16 weeks]
- Forced vital capacity [Срок оценки: Change from Baseline FVC at 16 weeks]
- FVC percentage of predicted normal values [Срок оценки: Change from Baseline FVC% at 16 weeks]
- Forced expiratory volume in one second [Срок оценки: Change from Baseline FEV1 at 16 weeks]
- The ratio of FEV1 to FVC [Срок оценки: Change from Baseline FEV1/FVC at 16 weeks]
- Respiration rates [Срок оценки: Change from Baseline respiration rates at 16 weeks]
- Respiration depths [Срок оценки: Change from Baseline respiration depths at 16 weeks]
Критерии участия
Критерии включения
- Subject with depression or anxiety symptom diagnosed by ICD-10.
- Depression 7≤HAMD-17≤29，anxiety 7≤HAMA-14≤29.
- Subject has a clear mind and the ability to read, to talk and to communicate.
- Subject agrees to participate in this study and sign to the informed consent.
Критерии исключения
- Subject with bipolar disorder, psychotic disorder, organic mental disorder and cognitive disorder.
- Subject with alcohol abuse, substance dependence and suicidal behavior in past-year.
- Subject has severe somatic disease.
- Subject is pregnant or lactating women.
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 · 1 центр
- Shanghai Qigong Research Institute — Шанхай
Идентификаторы
NCT: NCT05589337 · 202040253