Well-being Promotion and Sleep Hygiene Education to Improve Sleep Quality in a Non-clinical Population of Distressed Adults Reporting Poor Sleep: A Pilot Parallel-arm, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Changes in sleep onset latency
研究概览
简要总结
The overall goal of this project is to evaluate the effect of enhanced psychological well-being on sleep quality. This study will demonstrate whether combining an intervention designed to promote psychological well-being with sleep hygiene education improves sleep quality in a non-clinical population of distressed adults reporting poor sleep in the absence of a diagnosed sleep disorder. The investigators expect an intervention combining elements of psychological well-being and sleep hygiene education to result in significant improvements in sleep quality measures from baseline to post-intervention, and greater improvements in sleep quality measures at post-intervention as compared with sleep hygiene education alone.
详细描述
Psychological distress is often associated with poor sleep quality. The role of psychological well-being has often been neglected and most interventions for sleep improvement have focused primarily on sleep disorders. This approach is limited to those individuals who have specific conditions and little resources have been directed to the promotion of sleep quality in the general population.
This study will be a pilot parallel-arm, randomized controlled trial to assess the baseline associations between psychological well-being and different measures of sleep outcomes, determine the effect of elements of a psychological well-being promoting intervention on sleep quality, and examine effect size estimates of key sleep-related outcomes (duration, efficiency, quality) to provide essential data to inform a main efficacy trial.
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
- Single (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
- 是
入选标准
- •Age 18-65 years
- •Distress according to the Perceived Stress Scale
- •Poor sleep quality according to the Pittsburgh Sleep Quality Index
- •No diagnosis of sleep disorders
- •English fluency
- •Access to a computer with an Internet connection
排除标准
- •Inability to provide informed consent for any reason
- •Cognitive impairment according to the Montreal Cognitive Assessment
- •Suspected presence of sleep apnea according to the Berlin Questionnaire
- •Diagnosis of a chronic medical or psychiatric condition
- •Severe depression or suicidal thoughts or wishes according to the Beck Depression Inventory
- •Body Mass Index (BMI) ≥ 35 kg/m2
- •Chronic use of medications for sleep or chronic medical and psychiatric conditions
- •Any current psychological or behavioral intervention administered by a health care provider or as part of a research project
- •Shift workers
- •Pregnant women
- •Parents or caregivers of newborns (<1 year)
- •Heavy drinkers (≥ 8 drinks/week for women and ≥ 15 drinks/week for men)
- •Binge drinkers (≥ 4 drinks on a single occasion within about 2 hours for women and ≥ 5 drinks on a single occasion within about 2 hours for men
- •Use of recreational or street drugs
- •Heavy smokers (≥ 20 cigarettes daily)
- •Heavy caffeine users (> 400 mg a day, corresponding to about 4 or 5 cups of coffee)
结局指标
主要结局
Changes in sleep onset latency
时间窗: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Change in insomnia severity: Insomnia Severity Index (ISI)
时间窗: Baseline to immediate post-intervention
Measured by the Insomnia Severity Index (ISI), a 7-item self-rated questionnaire to measure insomnia severity in the past 2 weeks. The total score ranges from 0-28, with higher scores indicating greater severity of insomnia. Scores of 8-14, 15-21, and 22-28 are indicative of subthreshold, moderate, and severe clinical insomnia, respectively.
Changes in wake after sleep onset
时间窗: Baseline to immediate post-intervention
Measured by self-reported sleep diary
Change in sleep quality: Pittsburgh Sleep Quality Index (PSQI)
时间窗: Baseline to immediate post-intervention
Measured by the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-rating scale for the assessment of sleep quality over a 1-month time interval. The PSQI yields 7 component scores and one global score. The component scores consist of subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is given a score from 0-3. The global score is calculated by summing the seven component scores, providing an overall score ranging from 0-21, where lower scores indicate a higher sleep quality.
Changes in total sleep time
时间窗: Baseline to immediate post-intervention
Measured by self-reported sleep diary
次要结局
- Change in psychological well-being(Baseline to immediate post-intervention)
- Change in psychological distress(Baseline to immediate post-intervention)
研究者
Marie-Pierre St-Onge
Associate Professor of Nutritional Medicine
Columbia University