SleepNCT04576260
Effect of CBT Intervention to Improve Sleep on Wellbeing, Dietary Intake and Food Preference
A study testing Cognitive Behavioural Therapy for Insomnia in people with Sleep and Diet, run by University of Glasgow at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Diet, Well Being
- What is being tested?
- Cognitive Behavioural Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 16 Oct 2020to 9 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Glasgow
Glasgow, G12 8QQ
University of Glasgow
Glasgow, G12 8TA
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep, Diet, Well Being
- Being tested
- Cognitive Behavioural Therapy for Insomnia
- Keywords
- Sleep Extension, Sleep deprivation, Dietary intake, Well being, Cognitive Behavioural Therapy, Cognitive Behavioural Therapy for Insomnia, CBTi, Sleep Quality
- Medical subject headings
- Sleep Deprivation, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy for InsomniaBehavioural
Weekly CBTI training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioural Therapy for Insomnia |
| Control group | No intervention | The control group will be asked to maintain the usual lifestyle for the duration of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Duration
Change in accelerometer measured total sleep time
Measured: 0-12 weeks
Secondary outcomes (19)
Sleep Efficiency
Changes in Accelerometer measured sleep efficiency
Measured: 0-12 weeks
Sleep Latency
Changes in Accelerometer measured sleep latency
Measured: 0-12 weeks
Total Sleep Time
Changes in Accelerometer measured Total sleep Time
Measured: 0-12 weeks
Total Time in Bed
Changes in Accelerometer measured Total time in bed
Measured: 0-12 weeks
Wake After Sleep Onset
Changes in Accelerometer measured Wake after sleep onset
Measured: 0-12 weeks
Subjective Sleep Quality
Changes in subjective sleep quality measured by The Pittsburgh Sleep Quality Index
Measured: 0-12 weeks
Sleep Disturbances
Changes in sleep disturbances measured by The Pittsburgh Sleep Quality Index
Measured: 0-12 weeks
Use of Sleeping Medication
Changes in use of sleeping medication measured by The Pittsburgh Sleep Quality Index
Measured: 0-12 weeks
Daytime Dysfunction
Changes in daytime dysfunction measured by The Pittsburgh Sleep Quality Index
Measured: 0-12 weeks
Habitual Sleep Efficiency
Changes in habitual sleep efficiency measured by The Pittsburgh Sleep Quality Index
Measured: 0-12 weeks
Sleep Duration (self-reported)
Changes in sleep duration measured by The Pittsburgh Sleep Quality Index
Measured: 0-12 weeks
Excessive Daytime Sleepiness
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
Measured: 0-12 weeks
Mental Well-being
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.
Measured: 0-12 weeks
Depression
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
Measured: 0-12 weeks
Anxiety
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.
Measured: 0-12 weeks
Food preference
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.
Measured: 0-12 weeks
Food reward
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.
Measured: 0-12 weeks
Food cravings
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.
Measured: 0-12 weeks
Dietary Intake
Changes in 24 hour food recall measured by the Myfood24 food diary
Measured: 0-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start16 Oct 2020
- Primary completion1 Dec 2021
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised controlled trial with two groups CBT intervention group and control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Jason Gill, University of Glasgow
- Investigators
- Jason Gill, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576260
- Sponsor's protocol ID
- 200190177
- Status last verified
- Aug 2022
- First submitted
- 29 Sep 2020
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cognitive Behavioural Therapy Intervention to Improve Sleep on Wellbeing, Dietary Intake and Food Preference: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT04576260
- Acronym / sponsor ID
- 200190177
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 6 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised controlled trial with two groups CBT intervention group and control group.
| Arm | Type | Receives |
|---|---|---|
| CBT-I Group | Experimental | Behavioral: Cognitive Behavioural Therapy for InsomniaParticipants in the CBT-I group will undertake weekly sessions for a duration of 8 weeks with a trained psychologist through Zoom or Skype Calls. |
| Control group | No intervention | –The control group will be asked to maintain the usual lifestyle for the duration of the study |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy for InsomniaWeekly CBTI training | Behavioural | CBT-I Group |
Primary outcome
Sleep Duration
Time frame: 0-12 weeks
Change in accelerometer measured total sleep time
19 secondary outcomes
Sleep Efficiency
Time frame: 0-12 weeks
Sleep Latency
Time frame: 0-12 weeks
Total Sleep Time
Time frame: 0-12 weeks
Total Time in Bed
Time frame: 0-12 weeks
Wake After Sleep Onset
Time frame: 0-12 weeks
Subjective Sleep Quality
Time frame: 0-12 weeks
Sleep Disturbances
Time frame: 0-12 weeks
Use of Sleeping Medication
Time frame: 0-12 weeks
Daytime Dysfunction
Time frame: 0-12 weeks
Habitual Sleep Efficiency
Time frame: 0-12 weeks
Sleep Duration (self-reported)
Time frame: 0-12 weeks
Excessive Daytime Sleepiness
Time frame: 0-12 weeks
Mental Well-being
Time frame: 0-12 weeks
Depression
Time frame: 0-12 weeks
Anxiety
Time frame: 0-12 weeks
Food preference
Time frame: 0-12 weeks
Food reward
Time frame: 0-12 weeks
Food cravings
Time frame: 0-12 weeks
Dietary Intake
Time frame: 0-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Gill, PhD principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy for Insomnia in people with Sleep and Diet, run by University of Glasgow at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Duration (time frame: 0-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.