NCT04576260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1.1 years

First QC Date

September 29, 2020

Last Update Submit

August 26, 2022

Conditions

SleepDietWell Being

Keywords

Sleep ExtensionSleep deprivationDietary intakeWell beingCognitive Behavioural TherapyCognitive Behavioural Therapy for InsomniaCBTiSleep Quality

Outcome Measures

Primary Outcomes (1)

  • Sleep Duration

    Change in accelerometer measured total sleep time

    0-12 weeks

Secondary Outcomes (19)

  • Sleep Efficiency

    0-12 weeks

  • Sleep Latency

    0-12 weeks

  • Total Sleep Time

    0-12 weeks

  • Total Time in Bed

    0-12 weeks

  • Wake After Sleep Onset

    0-12 weeks

  • +14 more secondary outcomes

Other Outcomes (3)

  • Anthropometric Measures

    0-12 weeks

  • Anthropometric measures

    0-12 weeks

  • Participant Interviews

    0-12 weeks

Study Arms (2)

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.

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

Interventions

Cognitive Behavioural Therapy for InsomniaBEHAVIORAL

Weekly CBTI training

CBT-I Group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Glasgow

Glasgow, G12 8QQ, United Kingdom

Location

University of Glasgow

Glasgow, G12 8TA, United Kingdom

Location

MeSH Terms

Conditions

Sleep DeprivationSleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

DyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jason Gill, PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Members of the research team that perform measurements are blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised controlled trial with two groups CBT intervention group and control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2020

First Posted

October 6, 2020

Study Start

October 16, 2020

Primary Completion

December 1, 2021

Study Completion

May 9, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

GB(2)