NCT06658184招募中不适用
Effects of Sleep Restriction and Stimulus Control in Chronic Insomnia Patients With Prolonged Bed Rest and Maladaptive Sleep Patterns
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
研究概览
简要总结
The study aims to validate the effect of sleep restriction and stimulus control on improving chronic insomnia patients' sleep habits and maladaptive sleep behaviors.
详细描述
The purpose of sleep restriction is to reduce the patient's time in bed, bringing it closer to their actual sleep time, thereby improving sleep efficiency and quality. Stimulus control, on the other hand, aims to associate the bed with a rapid sense of falling asleep, reducing the negative association between the bed and insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for insomnia disorder as per DSM-
- •Pittsburgh Sleep Quality Index (PSQI) total score >
- •Age ≥ 18 years, at least a junior high school education level.
- •Assessment of sleep-wake behavior by sleep diary.
- •Assessment of "maladaptive sleep behavior" by self-designed 8-item questionnaire.
- •Voluntary participation in the study and signing an informed consent form.
排除标准
- •Presence of severe physical or severe mental illness, and suicide risk.
- •Clinical diagnosis or suspicion of sleep-breathing disorders, restless leg syndrome, and sleep-wake rhythm disorders, as well as individuals working in rotating shifts or with shift work.
- •Pregnant or lactating women.
- •Currently undergoing any form of psychological therapy.
研究组 & 干预措施
Sleep hygiene education
Active Comparator
干预措施: sleep hygiene education (Behavioral)
sleep restriction and stimulus control
Experimental
干预措施: sleep restriction and stimulus control (Behavioral)
结局指标
主要结局
The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 6 weeks
时间窗: Baseline, 6 weeks
The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality.
次要结局
- The change of PSQI total scores from baseline to 3 months, 6 months, and 12 months(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(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(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(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(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(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(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(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(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(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(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(Baseline, 3 months, 6 months, 12 months, 18 months, and 24 months)
研究者
研究点 (1)
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