Clinical trial NCT06300684: Exploring CBTi's Dual Effect on Sleep, Diet, & Chrononutrition
Official title: Sleep, Diet and Chrononutrition: Studying the Dual Effect of Cognitive Behavioral Therapy for Insomnia (CBTi) on Sleep and Dietary Habits
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Chrononutrition
Diet
Sleep
Circadian Rhythm
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This parallel-design interventional study randomly assigns participants to receive either Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education over four weeks. CBTi aims to enhance sleep quality, while the control group receives sleep hygiene education. Pre- and post-intervention assessments will measure sleep parameters and dietary habits, comparing outcomes between groups. Randomization ensures unbiased assignment. Statistical analysis evaluates CBTi's effectiveness in improving sleep patterns and diet, exploring the potential indirect impact of improved sleep on diet.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Bed Time
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Get Up Time
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Time in Bed
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Sleep Onset Latency (in minutes).
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Sleep Efficiency
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Wake After Sleep Onset
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Late-Night Eating Occasions number
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Eating Window Duration and Fasting Window Duration
timeFrame: immediately after the intervention of 4 weeks duration
measure: Change in Number of Meals
timeFrame: immediately after the intervention of 4 weeks duration
Secondary outcomes:
Other outcomes:
Locations:
city: Jbaïl
country: Lebanon
facility: Lebanese American University
state: Keserwan-Jbeil Governorate
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Farid Talih, MD
role: PRINCIPAL_INVESTIGATOR
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