Viability of an Early Sleep Intervention to Mitigate Poor Sleep and Improve Well-being in the COVID-19 Pandemic: Protocol for a Feasibility Randomized Controlled Trial

Kathleen Patricia O'Hora, Raquel A Osorno, Dena Sadeghi-Bahmani, Mateo Lopez, Allison Morehouse, Jane P Kim, Rachel Manber, Andrea N Goldstein-Piekarski, Kathleen Patricia O'Hora, Raquel A Osorno, Dena Sadeghi-Bahmani, Mateo Lopez, Allison Morehouse, Jane P Kim, Rachel Manber, Andrea N Goldstein-Piekarski

Abstract

Background: The COVID-19 pandemic has led to drastic increases in the prevalence and severity of insomnia symptoms. These increases in insomnia complaints have been paralleled by significant decreases in well-being, including increased symptoms of depression, anxiety, and suicidality and decreased quality of life. However, the efficacy and impact of early treatment of insomnia symptoms on future sleep and well-being remain unknown.

Objective: Here, we present the framework and protocol for a novel feasibility, pilot study that aims to investigate whether a brief telehealth insomnia intervention targeting new insomnia that developed during the pandemic prevents deterioration of well-being, including symptoms of insomnia, depression, anxiety, suicidality, and quality of life.

Methods: The protocol details a 2-arm randomized controlled feasibility trial to investigate the efficacy of a brief, telehealth-delivered, early treatment of insomnia and evaluate its potential to prevent deterioration of well-being. Participants with clinically significant insomnia symptoms that began during the pandemic were randomized to either a treatment group or a 28-week waitlist control group. Treatment consists of 4 telehealth sessions of cognitive behavioral therapy for insomnia (CBT-I) delivered over 5 weeks. All participants will complete assessments of insomnia symptom severity, well-being, and daily habits checklist at baseline (week 0) and at weeks 1-6, 12, 28, and 56.

Results: The trial began enrollment on June 3, 2020 and closed enrollment on June 17, 2021. As of October 2021, 49 participants had been randomized to either immediate treatment or a 28-week waitlist; 23 participants were still active in the protocol.

Conclusions: To our knowledge, this protocol would represent the first study to test an early sleep intervention for improving insomnia that emerged during the COVID-19 pandemic. The findings of this feasibility study could provide information about the utility of CBT-I for symptoms that emerge in the context of other stressors before they develop a chronic course and deepen understanding of the relationship between sleep and well-being.

Trial registration: ClinicalTrials.gov NCT04409743; https://ichgcp.net/clinical-trials-registry/NCT04409743.

International registered report identifier (irrid): DERR1-10.2196/34409.

Keywords: CBT-I; COVID-19; cognitive behavioral therapy; depression; impact; insomnia; mental health; pandemic; sleep; telehealth; telemedicine; therapy; well-being.

Conflict of interest statement

Conflicts of Interest: None declared.

©Kathleen Patricia O'Hora, Raquel A Osorno, Dena Sadeghi-Bahmani, Mateo Lopez, Allison Morehouse, Jane P Kim, Rachel Manber, Andrea N Goldstein-Piekarski. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 14.03.2022.

Figures

Figure 1
Figure 1
Study flow for each treatment group from prescreening through the 56-week follow-up, with primary outcome time points occurring at weeks 6, 12, and 28. CBT-I: cognitive behavioral therapy for insomnia.
Figure 2
Figure 2
Study design in which the period between week 0 to week 28 is the waitlist-controlled period in which the immediate treatment group (cognitive behavioral therapy for insomnia [CBT-I]) can be directly compared with the waitlist control group (no CBT-I). At 28 weeks, participants in the waitlist group begin therapy and become the delayed treatment group.
Figure 3
Figure 3
Mediation Model of Insomnia Severity Improvements mediating the change in well-being associated with the intervention.

References

    1. Marelli S, Castelnuovo A, Somma A, Castronovo V, Mombelli S, Bottoni D, Leitner C, Fossati A, Ferini-Strambi L. Impact of COVID-19 lockdown on sleep quality in university students and administration staff. J Neurol. 2021 Jan;268(1):8–15. doi: 10.1007/s00415-020-10056-6. 10.1007/s00415-020-10056-6
    1. Li Y, Qin Q, Sun Q, Sanford LD, Vgontzas AN, Tang X. Insomnia and psychological reactions during the COVID-19 outbreak in China. J Clin Sleep Med. 2020 Aug 15;16(8):1417–1418. doi: 10.5664/jcsm.8524. doi: 10.5664/jcsm.8524.
    1. Hyun S, Hahm HC, Wong GTF, Zhang E, Liu CH. Psychological correlates of poor sleep quality among U.S. young adults during the COVID-19 pandemic. Sleep Med. 2021 Feb;78:51–56. doi: 10.1016/j.sleep.2020.12.009. S1389-9457(20)30559-1
    1. Gualano MR, Lo Moro G, Voglino G, Bert F, Siliquini R. Effects of Covid-19 lockdown on mental health and sleep disturbances in Italy. Int J Environ Res Public Health. 2020 Jul 02;17(13):1. doi: 10.3390/ijerph17134779. ijerph17134779
    1. Yu BY, Yeung W, Lam JC, Yuen SC, Lam SC, Chung VC, Chung K, Lee PH, Ho FY, Ho JY. Prevalence of sleep disturbances during COVID-19 outbreak in an urban Chinese population: a cross-sectional study. Sleep Med. 2020 Oct;74:18–24. doi: 10.1016/j.sleep.2020.07.009. S1389-9457(20)30310-5
    1. Kokou-Kpolou CK, Megalakaki O, Laimou D, Kousouri M. Insomnia during COVID-19 pandemic and lockdown: Prevalence, severity, and associated risk factors in French population. Psychiatry Res. 2020 Aug;290:113128. doi: 10.1016/j.psychres.2020.113128. S0165-1781(20)31517-1
    1. LeBlanc M, Mérette C, Savard J, Ivers H, Baillargeon L, Morin CM. Incidence and risk factors of insomnia in a population-based sample. Sleep. 2009 Aug;32(8):1027–37. doi: 10.1093/sleep/32.8.1027.
    1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97–111. doi: 10.1053/smrv.2002.0186.S1087079202901863
    1. Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors associated with mental health outcomes among health care workers exposed to coronavirus disease 2019. JAMA Netw Open. 2020 Mar 02;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976. 2763229
    1. Pinto J, van Zeller M, Amorim P, Pimentel A, Dantas P, Eusébio E, Neves A, Pipa J, Santa Clara E, Santiago T, Viana P, Drummond M. Sleep quality in times of Covid-19 pandemic. Sleep Med. 2020 Oct;74:81–85. doi: 10.1016/j.sleep.2020.07.012. S1389-9457(20)30313-0
    1. Stanton R, To QG, Khalesi S, Williams SL, Alley SJ, Thwaite TL, Fenning AS, Vandelanotte C. Depression, anxiety and stress during COVID-19: associations with changes in physical activity, sleep, tobacco and alcohol use in Australian adults. Int J Environ Res Public Health. 2020 Jun 07;17(11):1. doi: 10.3390/ijerph17114065. ijerph17114065
    1. Zhang Y, Zhang H, Ma X, Di Q. Mental health problems during the COVID-19 pandemics and the mitigation effects of exercise: a longitudinal study of college students in China. Int J Environ Res Public Health. 2020 May 25;17(10):1. doi: 10.3390/ijerph17103722. ijerph17103722
    1. Grossman ES, Hoffman YSG, Palgi Y, Shrira A. COVID-19 related loneliness and sleep problems in older adults: Worries and resilience as potential moderators. Pers Individ Dif. 2021 Jan 01;168:110371. doi: 10.1016/j.paid.2020.110371. S0191-8869(20)30562-6
    1. Cellini N, Canale N, Mioni G, Costa S. Changes in sleep pattern, sense of time and digital media use during COVID-19 lockdown in Italy. J Sleep Res. 2020 Aug;29(4):e13074. doi: 10.1111/jsr.13074. doi: 10.1111/jsr.13074.
    1. Hale L, Guan S. Screen time and sleep among school-aged children and adolescents: a systematic literature review. Sleep Med Rev. 2015 Jun;21:50–8. doi: 10.1016/j.smrv.2014.07.007. S1087-0792(14)00081-1
    1. Gubelmann C, Heinzer R, Haba-Rubio J, Vollenweider P, Marques-Vidal P. Physical activity is associated with higher sleep efficiency in the general population: the CoLaus study. Sleep. 2018 Jul 01;41(7):1. doi: 10.1093/sleep/zsy070.4956778
    1. Deng J, Zhou F, Hou W, Silver Z, Wong CY, Chang O, Huang E, Zuo QK. The prevalence of depression, anxiety, and sleep disturbances in COVID-19 patients: a meta-analysis. Ann N Y Acad Sci. 2021 Feb;1486(1):90–111. doi: 10.1111/nyas.14506.
    1. Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate psychological responses and associated factors during the initial stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the general population in China. Int J Environ Res Public Health. 2020 Mar 06;17(5):1. doi: 10.3390/ijerph17051729. ijerph17051729
    1. Qiu J, Shen B, Zhao M, Wang Z, Xie B, Xu Y. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: implications and policy recommendations. Gen Psychiatr. 2020;33(2):e100213. doi: 10.1136/gpsych-2020-100213. gpsych-2020-100213
    1. Huckins JF, daSilva AW, Wang W, Hedlund E, Rogers C, Nepal SK, Wu J, Obuchi M, Murphy EI, Meyer ML, Wagner DD, Holtzheimer PE, Campbell AT. Mental health and behavior of college students during the early phases of the COVID-19 pandemic: longitudinal smartphone and ecological momentary assessment study. J Med Internet Res. 2020 Jun 17;22(6):e20185. doi: 10.2196/20185. v22i6e20185
    1. Fernández-Abascal EG, Martín-Díaz MD. Longitudinal study on affect, psychological well-being, depression, mental and physical health, prior to and during the COVID-19 pandemic in Spain. Pers Individ Dif. 2021 Apr;172:110591. doi: 10.1016/j.paid.2020.110591. S0191-8869(20)30782-0
    1. Romero-Gonzalez B, Puertas-Gonzalez JA, Mariño-Narvaez C, Peralta-Ramirez MI. [Confinement variables by COVID-19 predictors of anxious and depressive symptoms in pregnant women] Med Clin (Barc) 2021 Feb 26;156(4):172–176. doi: 10.1016/j.medcli.2020.10.002. S0025-7753(20)30742-9
    1. Hertenstein E, Feige B, Gmeiner T, Kienzler C, Spiegelhalder K, Johann A, Jansson-Fröjmark M, Palagini L, Rücker G, Riemann D, Baglioni C. Insomnia as a predictor of mental disorders: A systematic review and meta-analysis. Sleep Med Rev. 2019 Feb;43:96–105. doi: 10.1016/j.smrv.2018.10.006.S1087-0792(18)30113-8
    1. Qaseem A, Kansagara D, Forciea MA, Cooke M, Denberg TD, Clinical Guidelines Committee of the American College of Physicians Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125–33. doi: 10.7326/M15-2175. 2518955
    1. Trauer JM, Qian MY, Doyle JS, Rajaratnam SMW, Cunnington D. Cognitive behavioral therapy for chronic insomnia: a systematic review and meta-analysis. Ann Intern Med. 2015 Aug 04;163(3):191–204. doi: 10.7326/M14-2841.2301405
    1. Koffel EA, Koffel JB, Gehrman PR. A meta-analysis of group cognitive behavioral therapy for insomnia. Sleep Med Rev. 2015 Feb;19:6–16. doi: 10.1016/j.smrv.2014.05.001. S1087-0792(14)00048-3
    1. Arnedt JT, Conroy DA, Mooney A, Furgal A, Sen A, Eisenberg D. Telemedicine versus face-to-face delivery of cognitive behavioral therapy for insomnia: a randomized controlled noninferiority trial. Sleep. 2021 Jan 21;44(1):1. doi: 10.1093/sleep/zsaa136.5870824
    1. Altena E, Baglioni C, Espie CA, Ellis J, Gavriloff D, Holzinger B, Schlarb A, Frase L, Jernelöv S, Riemann D. Dealing with sleep problems during home confinement due to the COVID-19 outbreak: Practical recommendations from a task force of the European CBT-I Academy. J Sleep Res. 2020 Aug;29(4):e13052. doi: 10.1111/jsr.13052. doi: 10.1111/jsr.13052.
    1. Gebara MA, Siripong N, DiNapoli EA, Maree RD, Germain A, Reynolds CF, Kasckow JW, Weiss PM, Karp JF. Effect of insomnia treatments on depression: A systematic review and meta-analysis. Depress Anxiety. 2018 Aug;35(8):717–731. doi: 10.1002/da.22776.
    1. Bélanger L, Harvey AG, Fortier-Brochu E, Beaulieu-Bonneau S, Eidelman P, Talbot L, Ivers H, Hein K, Lamy M, Soehner AM, Mérette C, Morin CM. Impact of comorbid anxiety and depressive disorders on treatment response to cognitive behavior therapy for insomnia. J Consult Clin Psychol. 2016 Aug;84(8):659–67. doi: 10.1037/ccp0000084. 2016-12352-001
    1. Luik AI, Kyle SD, Espie CA. Digital cognitive behavioral therapy (dCBT) for insomnia: a state-of-the-science review. Curr Sleep Med Rep. 2017;3(2):48–56. doi: 10.1007/s40675-017-0065-4. 65
    1. Trockel M, Karlin BE, Taylor CB, Brown GK, Manber R. Effects of cognitive behavioral therapy for insomnia on suicidal ideation in veterans. Sleep. 2015 Feb 01;38(2):259–65. doi: 10.5665/sleep.4410. sp-00852-13
    1. Scott A, Webb T, Martyn-St James M, Rowse G, Weich S. Improving sleep quality leads to better mental health: A meta-analysis of randomised controlled trials. Sleep Med Rev. 2021 Dec;60:101556. doi: 10.1016/j.smrv.2021.101556. S1087-0792(21)00141-6
    1. Manber R, Buysse DJ, Edinger J, Krystal A, Luther JF, Wisniewski SR, Trockel M, Kraemer HC, Thase ME. Efficacy of cognitive-behavioral therapy for insomnia combined with antidepressant pharmacotherapy in patients with comorbid depression and insomnia: a randomized controlled trial. J Clin Psychiatry. 2016 Oct;77(10):e1316–e1323. doi: 10.4088/JCP.15m10244.
    1. Morin CM. Insomnia: Psychological assessment and management. New York, NY: Guilford Press; 1993.
    1. Morin CM, Belleville G, Bélanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 01;34(5):601–8. doi: 10.1093/sleep/34.5.601.
    1. Borbely AA. Concepts and models of sleep regulation: a preface. Journal of Sleep Research. 1992;1(2):61. doi: 10.1111/j.1365-2869.1992.tb00012.x.
    1. Spielman AJ, Saskin P, Thorpy MJ. Treatment of chronic insomnia by restriction of time in bed. Sleep. 1987 Feb;10(1):45–56.
    1. Bootzin RR, Epstein D, Wood JM. Stimulus Control Instructions. In: Hauri PJ, editor. Case Studies in Insomnia. Critical Issues in Psychiatry (An Educational Series for Residents and Clinicians) Boston, MA: Springer; 1991. pp. 19–28.
    1. Edinger J. Treatment Manual Cognitive-Behavioral Insomnia Therapy. [2022-02-13]. .
    1. Edinger J, Kirby A, Lineberger M, Loiselle M, Wohlgemuth W, Means M. The Duke Structured Interview Schedule for DSM-IV-TR and International Classification of Sleep Disorders. ICSD-2 Sleep Disord Diagnoses. 2009:1–78.
    1. Bazil CW. Seizure modulation by sleep and sleep state. Brain Res. 2019 Jan 15;1703:13–17. doi: 10.1016/j.brainres.2018.05.003.S0006-8993(18)30245-2
    1. Kaplan KA, Harvey AG. Behavioral treatment of insomnia in bipolar disorder. Am J Psychiatry. 2013 Jul;170(7):716–20. doi: 10.1176/appi.ajp.2013.12050708. 1700614
    1. Reeve S, Sheaves B, Freeman D. The role of sleep dysfunction in the occurrence of delusions and hallucinations: A systematic review. Clin Psychol Rev. 2015 Dec;42:96–115. doi: 10.1016/j.cpr.2015.09.001. S0272-7358(15)00119-1
    1. Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22–33;quiz 34.
    1. Draucker CB, Martsolf DS, Poole C. Developing distress protocols for research on sensitive topics. Arch Psychiatr Nurs. 2009 Oct;23(5):343–50. doi: 10.1016/j.apnu.2008.10.008.S0883-9417(08)00179-9
    1. Sheehan DV, Giddens JM, Sheehan IS. Status update on the Sheehan-Suicidality Tracking Scale (S-STS) 2014. Innov Clin Neurosci. 2014 Sep;11(9-10):93–140.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606–13. doi: 10.1046/j.1525-1497.2001.016009606.x. jgi01114
    1. Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20–40. doi: 10.1207/s15327752jpa6601_2.
    1. Kalmbach DA, Pillai V, Arnedt JT, Drake CL. Identifying at-risk individuals for insomnia using the Ford Insomnia Response to Stress Test. Sleep. 2016 Feb 01;39(2):449–56. doi: 10.5665/sleep.5462. sp-00179-15
    1. Jarrin DC, Chen IY, Ivers H, Drake CL, Morin CM. Temporal stability of the Ford Insomnia Response to Stress Test (FIRST) J Clin Sleep Med. 2016 Oct 15;12(10):1373–1378. doi: 10.5664/jcsm.6192. doi: 10.5664/jcsm.6192.jc-00152-16
    1. Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. Journal of Health and Social Behavior. 1983 Dec;24(4):385. doi: 10.2307/2136404.
    1. Nikolaidis A, Paksarian D, Alexander L, Derosa J, Dunn J, Nielson DM, Droney I, Kang M, Douka I, Bromet E, Milham M, Stringaris A, Merikangas KR. The Coronavirus Health and Impact Survey (CRISIS) reveals reproducible correlates of pandemic-related mood states across the Atlantic. Sci Rep. 2021 Apr 14;11(1):8139. doi: 10.1038/s41598-021-87270-3. doi: 10.1038/s41598-021-87270-3.10.1038/s41598-021-87270-3
    1. Cohen S, Doyle WJ, Skoner DP, Rabin BS, Gwaltney JM. Social ties and susceptibility to the common cold. JAMA. 1997 Jun 25;277(24):1940–4.
    1. Craig CL, Marshall AL, Sjöström M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381–95. doi: 10.1249/01.MSS.0000078924.61453.FB.
    1. Spitzer RL, Kroenke K, Williams JBW, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092–7. doi: 10.1001/archinte.166.10.1092.166/10/1092
    1. Hays RD, Sherbourne CD, Mazel RM. The RAND 36-Item Health Survey 1.0. Health Econ. 1993 Oct;2(3):217–27. doi: 10.1002/hec.4730020305.
    1. Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: Psychometric properties. Journal of Consulting and Clinical Psychology. 1988;56(6):893–897. doi: 10.1037/0022-006X.56.6.893.
    1. Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588–97. doi: 10.1207/s15327752jpa6703_13.
    1. Beck AT, Steer RA, Brown GK. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
    1. Kraemer HC, Wilson GT, Fairburn CG, Agras WS. Mediators and moderators of treatment effects in randomized clinical trials. Arch Gen Psychiatry. 2002 Oct;59(10):877–83. doi: 10.1001/archpsyc.59.10.877.ynv10179
    1. Kraemer HC, Kiernan M, Essex M, Kupfer DJ. Health Psychol. 2008 Mar;27(2S):S101–8. doi: 10.1037/0278-6133.27.2(Suppl.).S101. 2008-03488-002
    1. Moore KL, Neugebauer R, Valappil T, Laan MJ. Robust extraction of covariate information to improve estimation efficiency in randomized trials. Stat Med. 2011 Aug 30;30(19):2389–408. doi: 10.1002/sim.4301.
    1. Benkeser D, Díaz I, Luedtke A, Segal J, Scharfstein D, Rosenblum M. Improving precision and power in randomized trials for COVID-19 treatments using covariate adjustment, for binary, ordinal, and time-to-event outcomes. Biometrics. 2021 Dec;77(4):1467–1481. doi: 10.1111/biom.13377.
    1. Irwin MR, Carrillo C, Sadeghi N, Bjurstrom MF, Breen EC, Olmstead R. Prevention of incident and recurrent major depression in older adults with insomnia: a randomized clinical trial. JAMA Psychiatry. 2022 Jan 01;79(1):33–41. doi: 10.1001/jamapsychiatry.2021.3422. 2786738

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