Clinical trial NCT04576260: Effect of CBT Intervention to Improve Sleep on Wellbeing, Dietary Intake and Food Preference
Official title: Effect of a Cognitive Behavioural Therapy Intervention to Improve Sleep on Wellbeing, Dietary Intake and Food Preference: a Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Diet
Well Being
Keywords: Sleep Extension
Sleep deprivation
Dietary intake
Well being
Cognitive Behavioural Therapy
Cognitive Behavioural Therapy for Insomnia
CBTi
Sleep Quality
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2020-10-06
Enrollment: 27
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomised controlled trial with two groups CBT intervention group and control group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

The study is a randomized control trial where all participants will undergo the screening and baseline measurements. On completion of these procedures, the participants in the intervention group will undergo an 8-week session plan for 1 hour every week conducted online by a certified CBT-i trained psychologist. On completion of the study, all participants will be asked to undertake post-intervention measures.

Eligibility criteria: Inclusion Criteria:

* BMI above 25kg/m2.
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sleep Duration
timeFrame: 0-12 weeks
Secondary outcomes:
measure: Sleep Efficiency
timeFrame: 0-12 weeks
measure: Sleep Latency
timeFrame: 0-12 weeks
measure: Total Sleep Time
timeFrame: 0-12 weeks
measure: Total Time in Bed
timeFrame: 0-12 weeks
measure: Wake After Sleep Onset
timeFrame: 0-12 weeks
measure: Subjective Sleep Quality
timeFrame: 0-12 weeks
measure: Sleep Disturbances
timeFrame: 0-12 weeks
measure: Use of Sleeping Medication
timeFrame: 0-12 weeks
measure: Daytime Dysfunction
timeFrame: 0-12 weeks
measure: Habitual Sleep Efficiency
timeFrame: 0-12 weeks
measure: Sleep Duration (self-reported)
timeFrame: 0-12 weeks
measure: Excessive Daytime Sleepiness
timeFrame: 0-12 weeks
measure: Mental Well-being
timeFrame: 0-12 weeks
measure: Depression
timeFrame: 0-12 weeks
measure: Anxiety
timeFrame: 0-12 weeks
measure: Food preference
timeFrame: 0-12 weeks
measure: Food reward
timeFrame: 0-12 weeks
measure: Food cravings
timeFrame: 0-12 weeks
measure: Dietary Intake
timeFrame: 0-12 weeks
Other outcomes:
measure: Anthropometric Measures
timeFrame: 0-12 weeks
measure: Anthropometric measures
timeFrame: 0-12 weeks
measure: Participant Interviews
timeFrame: 0-12 weeks
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
city: Glasgow
country: United Kingdom
facility: University of Glasgow
Study officials:
affiliation: University of Glasgow
name: Jason Gill, PhD
role: PRINCIPAL_INVESTIGATOR
References: