Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition

March 8, 2024 updated by: American University of Beirut Medical Center

Sleep, Diet and Chrononutrition: Studying the Dual Effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on Sleep and Dietary Habits

This study aims to investigate the effects of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleep patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are intricately linked, with dysregulated sleep associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can affect hormonal balance and circadian rhythm. Insomnia and obesity are interrelated public health concerns, with CBTi showing efficacy in improving sleep. This study will recruit participants with insomnia and randomly assign them to receive either CBTi or basic sleep hygiene education. Baseline assessments will include validated questionnaires about insomnia, dietary habits, and physical activity and a 7-day 24-hour diet recall sheets, as well as actigraphy for sleep parameters, and physical activity assessments. The intervention will last for four weeks, with post-intervention assessments conducted similarly to baseline.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the dual effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on both sleeping patterns and dietary habits in Lebanese adults with insomnia. Sleep patterns and dietary habits are known to be closely interconnected, with dysregulated sleep often associated with poor diet quality and increased snacking. Conversely, the types of nutrients consumed can influence hormonal balance and circadian rhythm, impacting overall sleep quality.

Participants meeting the criteria for insomnia will be recruited and randomly assigned to either the intervention group receiving CBTi or the control group receiving basic sleep hygiene education. Baseline assessments will include comprehensive sleep evaluations using validated measures such as the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and actigraphy for objective sleep parameters over 7 days prior to the intervention. Additionally, participants will complete 7-day 24-hour diet recall sheets to assess dietary habits. Physical activity assessments will also be conducted using the short form of the International Physical Activity Questionnaire (IPAQ). Emotional eating will also be assessed through an 18-item emotional eating questionnaire (EEQ).Patients will also complete the PHQ-4 (Patient Health Questionnaire 4) questionnaire for assessment of depression and anxiety.

During the intervention phase, participants in the treatment group will undergo Cognitive Behavioral Therapy for insomnia (CBTi) aimed at improving sleep quality, while those in the control group will receive placebo sleep intervention that consists of sleep hygiene tips. Post-intervention assessments will mirror baseline evaluations, allowing for the comparison of changes in sleep patterns and dietary habits between the two groups.

  • Data collection involves the use of physical questionnaires and actigraphy devices. Paper-based data is securely stored in a locked drawer accessible only to research personnel. Actigraphy data is retrieved using specialized software, and any invalid or corrupt data prompts reassessment. Regular audits ensure data accuracy.
  • Data entered into the registry undergoes thorough checks for consistency and adherence to predefined rules. Any discrepancies are flagged for further investigation and resolution.
  • Validated measures such as the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) are used alongside actigraphy to ensure accurate sleep data. Multiple sources are cross-referenced to enhance data accuracy.
  • Variables include diet parameters (e.g., Late-Night Eating occasions, Eating Period) and sleep parameters (e.g., Bed Time, Total Sleep Time). Each variable is clearly defined with coding information and normal ranges where applicable.
  • Recruitment occurs via snowball sampling and data collection through physical questionnaires. Data is digitized and tabulated for analysis using SPSS (Statistical Package for Social Sciences). Actigraphy data is analyzed using specialized software. Adverse events are reported and managed according to established procedures.
  • Sample size assessment to specify the number of participants: A total of 40 participants will be recruited for the study to ensure adequate statistical power.
  • Plan for missing data: Regular audits and checks allow early identification of missing data. Participants with missing data are prompted to provide the necessary information, or alternative participants are recruited.
  • Statistical analysis plan: Statistical analyses include Wilcoxon signed-rank tests to assess pre-post intervention improvements, Spearman bivariate analysis to explore correlations between diet and sleep parameters, and Mann-Whitney tests to compare intervention and control group outcomes.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Contact

Study Contact Backup

  • Name: Farid Talih, MD
  • Phone Number: 5663 00961 -1-350000
  • Email: ft10@aub.edu.lb

Study Locations

  • Lebanon
      • Beirut, Lebanon, 1100
        • Recruiting
        • American University of Beirut Medical center
        • Contact:
        • Principal Investigator:
          • Farid Talih, MD
        • Sub-Investigator:
          • Chadi Antoun, MD
        • Sub-Investigator:
          • Ismat Annan, MSc
    • Keserwan-Jbeil Governorate
      • Jbaïl, Keserwan-Jbeil Governorate, Lebanon, 1102-2801
        • Active, not recruiting
        • Lebanese American University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • English literate adult men and women participants aged 18 to 65 years with a complaint of insomnia.

Exclusion Criteria:

  • Participants under 18 years old or above 65 years old.
  • Participants with a known sleep disorder other than insomnia (sleep apnea, narcolepsy, or restless leg syndrome).
  • Participants with a history of neurological disease including epilepsy/seizures and traumatic brain injury.
  • Participants with active psychosis.
  • Participants with hearing impairment.

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT-i
The CBT-i group consists of participants who will receive Cognitive Behavioral Therapy for Insomnia (CBTi) over 4 weeks (1 session per week). This intervention involves structured sessions aimed at addressing maladaptive sleep behaviors and promoting healthy sleep habits. Participants in this group will engage in cognitive restructuring, relaxation techniques, and sleep hygiene education to improve sleep quality and duration. The goal of CBTi is to modify behaviors and thoughts that contribute to insomnia, leading to more restful and consolidated sleep patterns.
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)
This intervention involves structured sessions aimed at addressing maladaptive sleep behaviors and promoting healthy sleep habits. Participants in this group will engage in cognitive restructuring, relaxation techniques, and sleep hygiene education to improve sleep quality and duration. The goal of CBTi is to modify behaviors and thoughts that contribute to insomnia, leading to more restful and consolidated sleep patterns.
No Intervention: Sleep Hygiene
The Sleep Hygiene group consists of participants who will not receive any specific therapeutic intervention. Instead, participants in this group will receive basic sleep hygiene education, which includes general recommendations and guidance on healthy sleep habits, which does not involve a structured therapeutic intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Bed Time
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing Cognitive Behavioral Therapy for Insomnia (CBTi) are expected to demonstrate significant change in Bed Time (in hours).
immediately after the intervention of 4 weeks duration
Change in Get Up Time
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant improvements in Get Up Time (in hours).
immediately after the intervention of 4 weeks duration
Change in Time in Bed
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant improvements in Time in Bed (in hours).
immediately after the intervention of 4 weeks duration
Change in Sleep Onset Latency (in minutes).
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant reductions in Sleep Onset Latency (in minutes).
immediately after the intervention of 4 weeks duration
Change in Sleep Efficiency
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant improvements in Sleep Efficiency (percentage).
immediately after the intervention of 4 weeks duration
Change in Wake After Sleep Onset
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are expected to demonstrate significant decreases in Wake After Sleep Onset (in minutes).
immediately after the intervention of 4 weeks duration
Change in Late-Night Eating Occasions number
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are anticipated to demonstrate a decrease in late-night eating occasions.
immediately after the intervention of 4 weeks duration
Change in Eating Window Duration and Fasting Window Duration
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are anticipated to exhibit a narrower and more restricted eating window in hours and consequently an increase in the nightly fasting period.
immediately after the intervention of 4 weeks duration
Change in Number of Meals
Time Frame: immediately after the intervention of 4 weeks duration
Participants undergoing CBTi are anticipated to experience alterations in the number of meals consumed.
immediately after the intervention of 4 weeks duration

Collaborators and Investigators

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

Sponsor

American University of Beirut Medical Center

Investigators

  • Principal Investigator: Farid Talih, MD, American University of Beirut Medical center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 11, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBS-2022-0085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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