Идёт набор NCT06658171
Effects of Relaxation Training and Stimulus Control in Chronic Insomnia 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: Relaxation training and stimulus control, Sleep hygiene education.
- Кому может быть актуально
- Состояния в реестре: Chronic Insomnia. 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
- 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 Relaxation Training and Stimulus Control in Chronic Insomnia Patients With Hyperarousal and Maladaptive Sleep Patterns
Обзор
The study aims to validate the effect of relaxation training and stimulus control on reducing hyperarousal states and improving maladaptive sleep behaviors.
Подробное описание
Relaxation training typically includes techniques such as breathing exercises, muscle relaxation, and mindfulness meditation to help patients reduce levels of physical and psychological tension, promote relaxation, and create favorable conditions for sleep onset. Stimulus control aims to break the negative association between the bed and insomnia, and rebuild a positive association between the bed and sleep.
Вмешательства
- Поведенческое Relaxation training and stimulus control
Relaxation training: Progressive muscle relaxation; Breathing relaxation; Imagery training; Mindfulness relaxation. Stimulus control: a) Reduce wakeful time in bed and rebuild a positive association between sleepiness and bed; b) Use the bed solely for sleeping and sexual activities; c) Only go to bed when feeling sleepy at night or at the designated sleep time; d) If unable to fall asleep within about 20 minutes of being in bed, leave the bedroom and engage in relaxation activities until feeli - Поведенческое Sleep hygiene education
1. Sleep until feeling refreshed the next day. 2. Maintain regular exercise and eating habits, avoiding going to bed on an empty stomach. 3. Ensure a comfortable bedroom environment with suitable nighttime temperature, free from light and noise disturbances. 4. Avoid excessive consumption of beverages, alcohol, and smoking at night, and reduce caffeine intake. 5. Avoid bringing problems to bed and refrain from attempting to sleep. 6. Place the alarm clock under the bed or move it away from sight
Первичные конечные точки
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks. [Срок оценки: Baseline, 6 weeks]
Вторичные конечные точки (12)
- The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 3 months, 6 months, and 12 months]
- The change of Insomnia severity index (ISI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of sleep efficiency from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Snaith-Hamilton Pleasure Scale (SHAPS) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Short Form 36 (SF-36) total scores from baseline to 6 weeks, 3 months, 6 months, 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months.]
- The change of Patient Health Questionnaire-4 (PHQ-4) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Beck Depression Inventory (BDI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Beck Anxiety Inventory (BAI) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Patient Health Questionnaire-15 (PHQ-15) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of 5-item Perceived Deficits Questionnaire-Depression (PDQ-D-5) total scores from baseline to 6 weeks, 3 months, 6 months, and 12 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
- The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. [Срок оценки: Baseline, 6 weeks, 3 months, 6 months, and 12 months]
Критерии участия
Критерии включения
- Meet the diagnostic criteria for insomnia disorder according to DSM-5.
- Pittsburgh Sleep Quality Index (PSQI) total score > 5.
- Age ≥ 18 years, with at least a middle school education level.
- Anxiety symptoms meeting HAMA ≥ 14.
- "Self-developed 8-item questionnaire on maladaptive sleep behaviors" used to assess "maladaptive sleep behaviors."
- Voluntarily participate in this study and sign an informed consent form.
Критерии исключения
- Individuals with severe physical illnesses or severe mental disorders, at risk of suicide.
- Clinically diagnosed or suspected sleep-related breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as shift workers.
- Pregnant or lactating women.
- Currently undergoing any psychological therapy.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Xuanwu Hospital, Capital Medical University — Пекин
Идентификаторы
NCT: NCT06658171 · RT-SC-insomnia