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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300684
• Other study ID #: SBS-2022-0085
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2022
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: American University of Beirut Medical Center
• Contact: Chadi Antoun, MD
• Phone: +961 81 524 015
• Email: ca116[@]aub.edu.lb
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

Country	Name	City	State
Lebanon	American University of Beirut Medical Center	Beirut
Lebanon	Lebanese American University	Jbaïl	Keserwan-Jbeil Governorate

Sponsors (1)

Lead Sponsor	Collaborator
American University of Beirut Medical Center

Country where clinical trial is conducted

Lebanon, 

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* Note: There are 38 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bed Time	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
Primary	Change in Get Up Time	Participants undergoing CBTi are expected to demonstrate significant improvements in Get Up Time (in hours).	immediately after the intervention of 4 weeks duration
Primary	Change in Time in Bed	Participants undergoing CBTi are expected to demonstrate significant improvements in Time in Bed (in hours).	immediately after the intervention of 4 weeks duration
Primary	Change in Sleep Onset Latency (in minutes).	Participants undergoing CBTi are expected to demonstrate significant reductions in Sleep Onset Latency (in minutes).	immediately after the intervention of 4 weeks duration
Primary	Change in Sleep Efficiency	Participants undergoing CBTi are expected to demonstrate significant improvements in Sleep Efficiency (percentage).	immediately after the intervention of 4 weeks duration
Primary	Change in Wake After Sleep Onset	Participants undergoing CBTi are expected to demonstrate significant decreases in Wake After Sleep Onset (in minutes).	immediately after the intervention of 4 weeks duration
Primary	Change in Late-Night Eating Occasions number	Participants undergoing CBTi are anticipated to demonstrate a decrease in late-night eating occasions.	immediately after the intervention of 4 weeks duration
Primary	Change in Eating Window Duration and Fasting Window 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
Primary	Change in Number of Meals	Participants undergoing CBTi are anticipated to experience alterations in the number of meals consumed.	immediately after the intervention of 4 weeks duration