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

NCT06300684 | Recruiting

• 1 other identifier: SBS-2022-0085
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Insomnia

Keywords

Chrononutrition; Diet; Sleep; Circadian Rhythm

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

CBT-i

EXPERIMENTAL

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)

Sleep Hygiene

NO INTERVENTION

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.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-i) BEHAVIORAL

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.

CBT-i

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (2)

Lebanese American University

Byblos, Keserwan-Jbeil Governorate, 1102-2801, Lebanon

ACTIVE NOT RECRUITING

American University of Beirut Medical Center

Beirut, 1100, Lebanon

RECRUITING

Related Publications (38)

• Zuraikat FM, Wood RA, Barragan R, St-Onge MP. Sleep and Diet: Mounting Evidence of a Cyclical Relationship. Annu Rev Nutr. 2021 Oct 11;41:309-332. doi: 10.1146/annurev-nutr-120420-021719. Epub 2021 Aug 4.

  PMID: 34348025 BACKGROUND

• Ferini-Strambi L, Auer R, Bjorvatn B, Castronovo V, Franco O, Gabutti L, Galbiati A, Hajak G, Khatami R, Kitajima T, McEvoy D, Nissen C, Perlis M, Pevernagie DA, Randerath W, Riemann D, Rizzo G, Van Someren E, Vgontzas A, Barazzoni F, Bassetti C; European Sleep Foundation. Insomnia disorder: clinical and research challenges for the 21st century. Eur J Neurol. 2021 Jul;28(7):2156-2167. doi: 10.1111/ene.14784. Epub 2021 Apr 9.

  PMID: 33619858 BACKGROUND

• Buenaver LF, Townsend D, Ong JC. Delivering Cognitive Behavioral Therapy for Insomnia in the Real World: Considerations and Controversies. Sleep Med Clin. 2019 Jun;14(2):275-281. doi: 10.1016/j.jsmc.2019.01.008. Epub 2019 Mar 29.

  PMID: 31029193 BACKGROUND

• Davidson JR, Dawson S, Krsmanovic A. Effectiveness of Group Cognitive Behavioral Therapy for Insomnia (CBT-I) in a Primary Care Setting. Behav Sleep Med. 2019 Mar-Apr;17(2):191-201. doi: 10.1080/15402002.2017.1318753. Epub 2017 May 2.

  PMID: 28463015 BACKGROUND

• Siebern AT, Manber R. New developments in cognitive behavioral therapy as the first-line treatment of insomnia. Psychol Res Behav Manag. 2011;4:21-8. doi: 10.2147/PRBM.S10041. Epub 2011 Feb 25.

  PMID: 22114532 BACKGROUND

• Duraccio KM, Zaugg K, Jensen CD. Effects of Sleep Restriction on Food-Related Inhibitory Control and Reward in Adolescents. J Pediatr Psychol. 2019 Jul 1;44(6):692-702. doi: 10.1093/jpepsy/jsz008.

  PMID: 30861067 BACKGROUND

• Duraccio KM, Krietsch KN, Chardon ML, Van Dyk TR, Beebe DW. Poor sleep and adolescent obesity risk: a narrative review of potential mechanisms. Adolesc Health Med Ther. 2019 Sep 9;10:117-130. doi: 10.2147/AHMT.S219594. eCollection 2019.

  PMID: 31572040 BACKGROUND

• Goldschmidt AB, Evans EW, Saletin JM, O'Sullivan K, Koren D, Engel SG, Haedt-Matt A. Naturalistic, multimethod exploratory study of sleep duration and quality as predictors of dysregulated eating in youth with overweight and obesity. Appetite. 2020 Mar 1;146:104521. doi: 10.1016/j.appet.2019.104521. Epub 2019 Nov 18.

  PMID: 31751632 BACKGROUND

• Gupta K, Jansen EC, Campos H, Baylin A. Associations between sleep duration and Mediterranean diet score in Costa Rican adults. Appetite. 2022 Mar 1;170:105881. doi: 10.1016/j.appet.2021.105881. Epub 2021 Dec 21.

  PMID: 34942284 BACKGROUND

• Zhao M, Tuo H, Wang S, Zhao L. The Effects of Dietary Nutrition on Sleep and Sleep Disorders. Mediators Inflamm. 2020 Jun 25;2020:3142874. doi: 10.1155/2020/3142874. eCollection 2020.

  PMID: 32684833 BACKGROUND

• Galland L. Diet and inflammation. Nutr Clin Pract. 2010 Dec;25(6):634-40. doi: 10.1177/0884533610385703.

  PMID: 21139128 BACKGROUND

• Ngo-Nkondjock RV, Yuntao Z, Adnan H, Adnan SM, Cheteu TMW, Li Y. The chronotype conjecture in the association between dietary carbohydrate intake and high-sensitivity C-reactive protein (hs-CRP): a cross-sectional study from NHANES 2015 data. Sleep Sci. 2021 Jan-Mar;14(1):3-10. doi: 10.5935/1984-0063.20200047.

  PMID: 34104331 BACKGROUND

• Afaghi A, O'Connor H, Chow CM. High-glycemic-index carbohydrate meals shorten sleep onset. Am J Clin Nutr. 2007 Feb;85(2):426-30. doi: 10.1093/ajcn/85.2.426.

  PMID: 17284739 BACKGROUND

• Du C, Almotawa J, Feldpausch CE, Folk SYL, Parag H, Tucker RM. Effects of macronutrient intake on sleep duration and quality: A systematic review. Nutr Diet. 2022 Feb;79(1):59-75. doi: 10.1111/1747-0080.12671. Epub 2021 Apr 19.

  PMID: 33876534 BACKGROUND

• Campanini MZ, Guallar-Castillon P, Rodriguez-Artalejo F, Lopez-Garcia E. Mediterranean Diet and Changes in Sleep Duration and Indicators of Sleep Quality in Older Adults. Sleep. 2017 Mar 1;40(3). doi: 10.1093/sleep/zsw083.

  PMID: 28364422 BACKGROUND

• Oike H, Oishi K, Kobori M. Nutrients, Clock Genes, and Chrononutrition. Curr Nutr Rep. 2014 Apr 27;3(3):204-212. doi: 10.1007/s13668-014-0082-6. eCollection 2014.

  PMID: 25101217 BACKGROUND

• Crispim CA, Zimberg IZ, dos Reis BG, Diniz RM, Tufik S, de Mello MT. Relationship between food intake and sleep pattern in healthy individuals. J Clin Sleep Med. 2011 Dec 15;7(6):659-64. doi: 10.5664/jcsm.1476.

  PMID: 22171206 BACKGROUND

• Nasreddine L, Naja F, Chamieh MC, Adra N, Sibai AM, Hwalla N. Trends in overweight and obesity in Lebanon: evidence from two national cross-sectional surveys (1997 and 2009). BMC Public Health. 2012 Sep 17;12:798. doi: 10.1186/1471-2458-12-798.

  PMID: 22984791 BACKGROUND

• Kang H. Sample size determination and power analysis using the G*Power software. J Educ Eval Health Prof. 2021;18:17. doi: 10.3352/jeehp.2021.18.17. Epub 2021 Jul 30.

  PMID: 34325496 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.

  PMID: 19996233 BACKGROUND

• Kliem S, Mossle T, Klatt T, Fleischer S, Kudlacek D, Kroger C, Brahler E, Beutel ME, Wiltink J. [Psychometric Evaluation of an Arabic Version of the PHQ-4 Based on a Representative Survey of Syrian Refugees]. Psychother Psychosom Med Psychol. 2016 Sep;66(9-10):385-392. doi: 10.1055/s-0042-114775. Epub 2016 Oct 10. German.

  PMID: 27723929 BACKGROUND

• Natale V, Plazzi G, Martoni M. Actigraphy in the assessment of insomnia: a quantitative approach. Sleep. 2009 Jun;32(6):767-71. doi: 10.1093/sleep/32.6.767.

  PMID: 19544753 BACKGROUND

• Knutson KL, Ryden AM, Mander BA, Van Cauter E. Role of sleep duration and quality in the risk and severity of type 2 diabetes mellitus. Arch Intern Med. 2006 Sep 18;166(16):1768-74. doi: 10.1001/archinte.166.16.1768.

  PMID: 16983057 BACKGROUND

• St-Onge MP, Grandner MA, Brown D, Conroy MB, Jean-Louis G, Coons M, Bhatt DL; American Heart Association Obesity, Behavior Change, Diabetes, and Nutrition Committees of the Council on Lifestyle and Cardiometabolic Health; Council on Cardiovascular Disease in the Young; Council on Clinical Cardiology; and Stroke Council. Sleep Duration and Quality: Impact on Lifestyle Behaviors and Cardiometabolic Health: A Scientific Statement From the American Heart Association. Circulation. 2016 Nov 1;134(18):e367-e386. doi: 10.1161/CIR.0000000000000444. Epub 2016 Sep 19.

  PMID: 27647451 BACKGROUND

• Fernandez-Mendoza J, Baker JH, Vgontzas AN, Gaines J, Liao D, Bixler EO. Insomnia symptoms with objective short sleep duration are associated with systemic inflammation in adolescents. Brain Behav Immun. 2017 Mar;61:110-116. doi: 10.1016/j.bbi.2016.12.026. Epub 2016 Dec 30.

  PMID: 28041986 BACKGROUND

• Irwin MR, Olmstead R, Carroll JE. Sleep Disturbance, Sleep Duration, and Inflammation: A Systematic Review and Meta-Analysis of Cohort Studies and Experimental Sleep Deprivation. Biol Psychiatry. 2016 Jul 1;80(1):40-52. doi: 10.1016/j.biopsych.2015.05.014. Epub 2015 Jun 1.

  PMID: 26140821 BACKGROUND

• Patel SR, Zhu X, Storfer-Isser A, Mehra R, Jenny NS, Tracy R, Redline S. Sleep duration and biomarkers of inflammation. Sleep. 2009 Feb;32(2):200-4. doi: 10.1093/sleep/32.2.200.

  PMID: 19238807 BACKGROUND

• Haus EL, Smolensky MH. Shift work and cancer risk: potential mechanistic roles of circadian disruption, light at night, and sleep deprivation. Sleep Med Rev. 2013 Aug;17(4):273-84. doi: 10.1016/j.smrv.2012.08.003. Epub 2012 Nov 6.

  PMID: 23137527 BACKGROUND

• Blask DE. Melatonin, sleep disturbance and cancer risk. Sleep Med Rev. 2009 Aug;13(4):257-64. doi: 10.1016/j.smrv.2008.07.007. Epub 2008 Dec 17.

  PMID: 19095474 BACKGROUND

• Gildner TE, Liebert MA, Kowal P, Chatterji S, Snodgrass JJ. Associations between sleep duration, sleep quality, and cognitive test performance among older adults from six middle income countries: results from the Study on Global Ageing and Adult Health (SAGE). J Clin Sleep Med. 2014 Jun 15;10(6):613-21. doi: 10.5664/jcsm.3782.

  PMID: 24932140 BACKGROUND

• Gillin JC. Are sleep disturbances risk factors for anxiety, depressive and addictive disorders? Acta Psychiatr Scand Suppl. 1998;393:39-43. doi: 10.1111/j.1600-0447.1998.tb05965.x.

  PMID: 9777046 BACKGROUND

• Breslau N, Roth T, Rosenthal L, Andreski P. Sleep disturbance and psychiatric disorders: a longitudinal epidemiological study of young adults. Biol Psychiatry. 1996 Mar 15;39(6):411-8. doi: 10.1016/0006-3223(95)00188-3.

  PMID: 8679786 BACKGROUND

• Connor J, Norton R, Ameratunga S, Robinson E, Civil I, Dunn R, Bailey J, Jackson R. Driver sleepiness and risk of serious injury to car occupants: population based case control study. BMJ. 2002 May 11;324(7346):1125. doi: 10.1136/bmj.324.7346.1125.

  PMID: 12003884 BACKGROUND

• Kapur V, Strohl KP, Redline S, Iber C, O'Connor G, Nieto J. Underdiagnosis of sleep apnea syndrome in U.S. communities. Sleep Breath. 2002 Jun;6(2):49-54. doi: 10.1007/s11325-002-0049-5.

  PMID: 12075479 BACKGROUND

• Rajaratnam SMW, Licamele L, Birznieks G. Delayed sleep phase disorder risk is associated with absenteeism and impaired functioning. Sleep Health. 2015 Jun;1(2):121-127. doi: 10.1016/j.sleh.2015.03.001. Epub 2015 Apr 25.

  PMID: 29073375 BACKGROUND

• Sivertsen B, Glozier N, Harvey AG, Hysing M. Academic performance in adolescents with delayed sleep phase. Sleep Med. 2015 Sep;16(9):1084-90. doi: 10.1016/j.sleep.2015.04.011. Epub 2015 May 18.

  PMID: 26298783 BACKGROUND

• Montie K, Quaedackers L, Perlitius V, van der Horst E, Vandenbussche N, Overeem S, Pillen S. The impact of delayed sleep phase disorder on adolescents and their family. Sleep Med. 2019 Dec;64:15-22. doi: 10.1016/j.sleep.2019.05.022. Epub 2019 Jun 22.

  PMID: 31655320 BACKGROUND

• Reimer MA, Flemons WW. Quality of life in sleep disorders. Sleep Med Rev. 2003 Aug;7(4):335-49. doi: 10.1053/smrv.2001.0220.

  PMID: 14505600 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Farid Talih, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chadi Antoun, MD

CONTACT

+961 81 524 015; ca116@aub.edu.lb

Farid Talih, MD

CONTACT

00961 -1-350000; ft10@aub.edu.lb

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the specific type of intervention they will receive, whether it is Cognitive Behavioral Therapy for Insomnia (CBTi) or basic sleep hygiene education.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 8, 2024
• Study Start: November 11, 2022
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

LE (2)