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临床试验/NCT04576260
NCT04576260已完成不适用

Effect of a Cognitive Behavioural Therapy Intervention to Improve Sleep on Wellbeing, Dietary Intake and Food Preference: a Feasibility Study.

University of Glasgow2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年10月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Sleep Duration

研究概览

简要总结

The study aims to investigate the effects of Cognitive Behavioural therapy intervention on sleep and it's effects on well-being, dietary intake and food preferences during COVID-19. The study will investigate whether delivery of a CBT intervention will lead to an improvement in sleep quality and sleep duration and will consequently improve metabolic health. The participants will be randomized into two groups with one half in the intervention arm and the other in the control arm of the study.

详细描述

Reduced sleep duration and sleep quality have become increasingly important areas in the study and epidemiology of sleep and are linked with numerous health risks. The Centers for Disease Control and Prevention have found that in the last few years there has been a significant reduction in sleep duration in adults, with an average duration of <7 hours, with some suggestion that this can contribute to increased risk of obesity and type 2 diabetes.

Studies on sleep restriction have observed that even a single night of sleep deprivation leads to a reduction in insulin sensitivity and increases the prevalence of diabetes. Similarly shortened and/or poor-quality sleep has been found to cause dysregulation in ghrelin and leptin levels, which can increase energy intake and motivation to seek out foods with higher fat and sugar content. Although a wide range of research focuses on the effects of short sleep and its impact on health, few studies have focused on whether improving sleep can improve cardiometabolic outcomes.

Research has estimated that almost 30% of individuals suffer from insomnia or insomnia like symptoms. The most common method to combat this has been over-the-counter medication and hypnotics; however, there is very little evidence available on the efficacy of such treatments. Over the years, Cognitive Behavioural Therapy has been found to produce long term and significant results in individuals with insomnia. It has shown to significantly improve the various parameters of sleep such as sleep latency, wake after sleep onset, sleep efficiency and sleep quality. Studies on patients with primary insomnia have shown that those undergoing CBT treatment improve their sleep by an average of 6 hours and improve their sleep efficiency. Furthermore, those undergoing CBT have shown long term improvements with healthy circadian rhythms, regulated hormonal secretory patterns and blood glucose levels.

A research study on short sleep duration with an intervention consisting of behavioural consultations focusing on extending sleep found that extending sleep, through this intervention, reduced the intake of free sugars, fat, and carbohydrates. Since CBT requires minimal intervention, it could be considered as the ideal mode of therapy to improve sleep.

In the current scenario, with the significant effects of COVID-19 observed on morbidity, daily lifestyle behaviours, and mental health, an effective psychological intervention may help to improve both mental and physiological health. This study aims to investigate the effects of an intervention which improves sleep on metabolic health outcomes. Through this study, the investigators aim to test the feasibility of a CBT intervention in improving sleep in our target population consisting of overweight/obese adults reporting poor sleep and to further understand participants' experiences with the CBT to improve health and sleep outcomes during a pandemic.

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)

盲法说明

Members of the research team that perform measurements are blinded to group allocation.

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •BMI above 25kg/m
  • •Self-reported sleep of <7hrs (confirmed through actigraphy).
  • •A global score of >5 on the Pittsburgh Sleep Quality Index (PSQI)
  • •Participants on any kind of self-prescribed or over the counter medication for sleep, will be included in the study after a two-week interval for elimination drug from the system.

排除标准

  • •Presence of sleep-related disorders measured through the Sleep Disorder Symptoms Checklist (SDSCL-25)
  • •Any serious medical conditions which might influence sleep i.e. cardiovascular diseases, diabetes, cancer, respiratory disease, other than mild asthma.
  • •History of bariatric surgery.
  • •Taking any kind of prescribed hypnotics or sleep medication
  • •Taking any kind of medication which might affect appetite
  • •Participating in any kind of dietary and/or weight loss programs
  • •Taking Antidepressants
  • •Substance or alcohol abuse
  • •Shift work
  • •Currently having to wake up at night to care for another person
  • •Suffering from and/or receiving treatment for a mental health conditions or sleep apnea.

研究组 & 干预措施

CBT-I Group

Experimental

Participants in the CBT-I group will undertake weekly sessions for a duration of 8 weeks with a trained psychologist through Zoom or Skype Calls.

干预措施: Cognitive Behavioural Therapy for Insomnia (Behavioral)

Control group

No Intervention

The control group will be asked to maintain the usual lifestyle for the duration of the study

结局指标

主要结局

Sleep Duration

时间窗: 0-12 weeks

Change in accelerometer measured total sleep time

次要结局

  • Sleep Efficiency(0-12 weeks)
  • Wake After Sleep Onset(0-12 weeks)
  • Dietary Intake(0-12 weeks)
  • Sleep Latency(0-12 weeks)
  • Total Time in Bed(0-12 weeks)
  • Sleep Disturbances(0-12 weeks)
  • Food preference(0-12 weeks)
  • Food cravings(0-12 weeks)
  • Total Sleep Time(0-12 weeks)
  • Daytime Dysfunction(0-12 weeks)
  • Habitual Sleep Efficiency(0-12 weeks)
  • Excessive Daytime Sleepiness(0-12 weeks)
  • Mental Well-being(0-12 weeks)
  • Depression(0-12 weeks)
  • Use of Sleeping Medication(0-12 weeks)
  • Sleep Duration (self-reported)(0-12 weeks)
  • Food reward(0-12 weeks)
  • Subjective Sleep Quality(0-12 weeks)
  • Anxiety(0-12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Jason Gill

Professor

University of Glasgow

研究点 (2)

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