Effect of CBT Intervention to Improve Sleep on Wellbeing, Dietary Intake and Food Preference

August 26, 2022 updated by: Professor Jason Gill, University of Glasgow

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 8QQ
        • University of Glasgow
      • Glasgow, United Kingdom, G12 8TA
        • University of Glasgow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: CBT-I Group
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.
Behavioral: Cognitive Behavioural Therapy for Insomnia
Weekly CBTI training
NO_INTERVENTION: Control group
The control group will be asked to maintain the usual lifestyle for the duration of the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep Duration
Time Frame: 0-12 weeks
Change in accelerometer measured total sleep time
0-12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep Efficiency
Time Frame: 0-12 weeks
Changes in Accelerometer measured sleep efficiency
0-12 weeks
Sleep Latency
Time Frame: 0-12 weeks
Changes in Accelerometer measured sleep latency
0-12 weeks
Total Sleep Time
Time Frame: 0-12 weeks
Changes in Accelerometer measured Total sleep Time
0-12 weeks
Total Time in Bed
Time Frame: 0-12 weeks
Changes in Accelerometer measured Total time in bed
0-12 weeks
Wake After Sleep Onset
Time Frame: 0-12 weeks
Changes in Accelerometer measured Wake after sleep onset
0-12 weeks
Subjective Sleep Quality
Time Frame: 0-12 weeks
Changes in subjective sleep quality measured by The Pittsburgh Sleep Quality Index
0-12 weeks
Sleep Disturbances
Time Frame: 0-12 weeks
Changes in sleep disturbances measured by The Pittsburgh Sleep Quality Index
0-12 weeks
Use of Sleeping Medication
Time Frame: 0-12 weeks
Changes in use of sleeping medication measured by The Pittsburgh Sleep Quality Index
0-12 weeks
Daytime Dysfunction
Time Frame: 0-12 weeks
Changes in daytime dysfunction measured by The Pittsburgh Sleep Quality Index
0-12 weeks
Habitual Sleep Efficiency
Time Frame: 0-12 weeks
Changes in habitual sleep efficiency measured by The Pittsburgh Sleep Quality Index
0-12 weeks
Sleep Duration (self-reported)
Time Frame: 0-12 weeks
Changes in sleep duration measured by The Pittsburgh Sleep Quality Index
0-12 weeks
Excessive Daytime Sleepiness
Time Frame: 0-12 weeks

Changes in excessive daytime sleepiness measured by the Epworth Sleepiness Scale

Scale range:

Would never nod off 0 Slight chance of nodding off 1 Moderate chance of nodding off 2 High chance of nodding off 3

Scoring Interpretation:

Minumum score is 0 and maximum score is 24. 0-5 - Lower Normal Daytime Sleepiness 6-10 - Higher Normal Daytime Sleepiness 11-12 - Mild Excessive Daytime Sleepiness 13-15 - Moderate Excessive Daytime Sleepiness 16-24 - Severe Excessive Daytime Sleepiness
0-12 weeks
Mental Well-being
Time Frame: 0-12 weeks

Changes in cognitive, affective and social dimensions of mental health measured by the Warwick-Edinburgh Mental Well-being Scale

Scale range:

None of the time 1 Rarely 2 Some of the time 3 Often 4 All of the time 5

Scoring Interpretation:

The minimum score is 14 and maximum score is 70. The higher the scores indicate a greater positive mental wellbeing.
0-12 weeks
Depression
Time Frame: 0-12 weeks

Changes in depressive symptoms measured by the Patient Health Questionnaire-9

Scale range:

Not at all 0 Several days 1 More than half the days 2 Nearly every day 3

Scoring Interpretation:

The minimum score is 0 and maximum score is 20. 0-5 - mild 6-10 - moderate 11-15 - moderately severe 16-20 - severe depression
0-12 weeks
Anxiety
Time Frame: 0-12 weeks

Changes in anxiety measured by the Generalized Anxiety Disorder-7

Scale range:

Not at all 0 Several days 1 More than half the days 2 Nearly every day 3

Scoring Interpretation:

The minimum score is 0 and maximum score is 21. 0-5 mild 6-10 moderate 11-15 moderately severe anxiety 15-21 severe anxiety.
0-12 weeks
Food preference
Time Frame: 0-12 weeks

Changes in explicit liking and explicit wanting measured by the Leeds Food Preference Questionnaire

Scale range:

The computerized asessment includes a 100mm visual analogue scale and at the end of the response item participants will be asked: "How much do you want some of this food now?

Scoring:

The minimum score for VAS scale is 0 and maximum is 100. Scores are recorded and converted in to mean scores for high fat, low fat, sweet or savoury food types and different fat-taste combinations.
0-12 weeks
Food reward
Time Frame: 0-12 weeks

Changes in implicit wanting and food choice measured by the Leeds Food Preference Questionnaire

Scale range:

The computerized asessment where participants are presented with two images and they choose which they like.

Scoring:

Reaction time for each answer is recorded and converted in to mean scores for high fat, low fat, sweet or savoury food types and different fat-taste combinations.
0-12 weeks
Food cravings
Time Frame: 0-12 weeks

Changes in craving control, craving for sweet, craving for savoury and positive mood measured by the Control of Eating Questionnaire

Scale range:

The asessment includes a 20 items with a 10 point scale ranging from "not at all" to "extremely" and 1 item with free text answer.

Scoring:

The minimum score for VAS scale is 0 and maximum is 100. The sum of items were calculated and divide by number of items in the subscale. Higher the score indicates higher cravings. Positive mood subscales and Craving Control subscales the scores were reversed, so great score indicated greater level of positve mood and craving control.
0-12 weeks
Dietary Intake
Time Frame: 0-12 weeks
Changes in 24 hour food recall measured by the Myfood24 food diary
0-12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anthropometric Measures
Time Frame: 0-12 weeks
Changes in self reported weight
0-12 weeks
Anthropometric measures
Time Frame: 0-12 weeks
Changes in self reported BMI
0-12 weeks
Participant Interviews
Time Frame: 0-12 weeks
Participant feedback and information provided through interviews
0-12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 200190177

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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