Идёт набор NCT06658158
Effects of Cognitive Correction 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: Cognitive correction 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 Cognitive Correction and Stimulus Control in Chronic Insomnia Patients With Sleep Cognitive Distortions and Maladaptive Sleep Patterns
Обзор
This study aims to validate the effect of cognitive correction and stimulus control on correcting sleep cognitive distortions and improving maladaptive sleep behaviors.
Подробное описание
Cognitive correction aims to identify and change patients' erroneous beliefs and attitudes about sleep, which may include exaggerated sleep needs, excessive worry about the consequences of insomnia, and unrealistic expectations about bedtime. Stimulus control, on the other hand, focuses on modifying patients' behaviors in bed, linking the bed with a rapid onset of sleep, and reducing the negative association between the bed and insomnia.
Вмешательства
- Поведенческое Cognitive correction and stimulus control
Cognitive correction: a) correcting unrealistic sleep expectations; b) maintaining a natural sleep onset; c) avoiding worry about losing control oversleep; d) not associating nocturnal dreaming with adverse daytime consequences; e) avoiding feelings of frustration due to one night of poor sleep; f) developing tolerance to the impact of insomnia and avoiding compensatory behaviors. Stimulus control: 1. Minimize wakefulness during time in bed and establish a positive association between sleepin - 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, 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
- Meets the diagnostic criteria for insomnia disorder according to DSM-5;
- PSQI total score > 5;
- Age ≥ 18 years, with at least a junior high school education;
- Sleep cognitive distortions assessed using the DBAS-16;
- "Maladaptive Sleep Behavior Questionnaire - 8 items" used to assess "maladaptive sleep behaviors";
- Willing to participate in the study and sign an informed consent form.
Критерии исключения
- Presence of severe physical illness or serious mental disorders, or at risk for suicide;
- Clinically diagnosed or suspected sleep-related breathing disorders, restless legs syndrome, and circadian rhythm sleep-wake disorders; shift workers;
- Pregnant or lactating women;
- Currently undergoing any form of 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: NCT06658158 · CC+SC-insomnia