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.
CBT-I
COVID-19
cognitive behavioral therapy
depression
impact
insomnia
mental health
pandemic
sleep
telehealth
telemedicine
therapy
well-being
Journal
JMIR research protocols
ISSN: 1929-0748
Titre abrégé: JMIR Res Protoc
Pays: Canada
ID NLM: 101599504
Informations de publication
Date de publication:
14 Mar 2022
14 Mar 2022
Historique:
received:
22
10
2021
accepted:
18
12
2021
revised:
07
12
2021
pubmed:
8
1
2022
medline:
8
1
2022
entrez:
7
1
2022
Statut:
epublish
Résumé
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. 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. 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. 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. 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. ClinicalTrials.gov NCT04409743; https://clinicaltrials.gov/ct2/show/NCT04409743. DERR1-10.2196/34409.
Sections du résumé
BACKGROUND
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
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
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
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
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
BACKGROUND
ClinicalTrials.gov NCT04409743; https://clinicaltrials.gov/ct2/show/NCT04409743.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
UNASSIGNED
DERR1-10.2196/34409.
Identifiants
pubmed: 34995204
pii: v11i3e34409
doi: 10.2196/34409
pmc: PMC8923148
doi:
Banques de données
ClinicalTrials.gov
['NCT04409743']
Types de publication
Journal Article
Langues
eng
Pagination
e34409Informations de copyright
©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.
Références
Arch Intern Med. 2006 May 22;166(10):1092-7
pubmed: 16717171
Sleep Med Rev. 2002 Apr;6(2):97-111
pubmed: 12531146
Sleep. 2021 Jan 21;44(1):
pubmed: 32658298
J Health Soc Behav. 1983 Dec;24(4):385-96
pubmed: 6668417
J Sleep Res. 2020 Aug;29(4):e13052
pubmed: 32246787
JAMA. 1997 Jun 25;277(24):1940-4
pubmed: 9200634
Brain Res. 2019 Jan 15;1703:13-17
pubmed: 29782849
J Sleep Res. 2020 Aug;29(4):e13074
pubmed: 32410272
J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57
pubmed: 9881538
J Consult Clin Psychol. 2016 Aug;84(8):659-67
pubmed: 26963600
Arch Gen Psychiatry. 2002 Oct;59(10):877-83
pubmed: 12365874
Sleep Med Rev. 2015 Feb;19:6-16
pubmed: 24931811
J Pers Assess. 1996 Dec;67(3):588-97
pubmed: 8991972
Clin Psychol Rev. 2015 Dec;42:96-115
pubmed: 26407540
Sci Rep. 2021 Apr 14;11(1):8139
pubmed: 33854103
Sleep. 2018 Jul 1;41(7):
pubmed: 29617980
Med Sci Sports Exerc. 2003 Aug;35(8):1381-95
pubmed: 12900694
Biometrics. 2021 Dec;77(4):1467-1481
pubmed: 32978962
J Consult Clin Psychol. 1988 Dec;56(6):893-7
pubmed: 3204199
Sleep. 2011 May 01;34(5):601-8
pubmed: 21532953
Health Econ. 1993 Oct;2(3):217-27
pubmed: 8275167
Sleep Med. 2021 Feb;78:51-56
pubmed: 33385779
Int J Environ Res Public Health. 2020 Jul 02;17(13):
pubmed: 32630821
J Sleep Res. 1992 Jun;1(2):63-79
pubmed: 10607028
Gen Psychiatr. 2020 Mar 6;33(2):e100213
pubmed: 32215365
J Clin Sleep Med. 2020 Aug 15;16(8):1417-1418
pubmed: 32351206
Curr Sleep Med Rep. 2017;3(2):48-56
pubmed: 28553574
J Pers Assess. 1996 Feb;66(1):20-40
pubmed: 8576833
Am J Psychiatry. 2013 Jul;170(7):716-20
pubmed: 23820830
Ann Intern Med. 2016 Jul 19;165(2):125-33
pubmed: 27136449
J Neurol. 2021 Jan;268(1):8-15
pubmed: 32654065
Pers Individ Dif. 2021 Apr;172:110591
pubmed: 33518870
Health Psychol. 2008 Mar;27(2S):S101-8
pubmed: 18377151
Depress Anxiety. 2018 Aug;35(8):717-731
pubmed: 29782076
Int J Environ Res Public Health. 2020 May 25;17(10):
pubmed: 32466163
Ann N Y Acad Sci. 2021 Feb;1486(1):90-111
pubmed: 33009668
Pers Individ Dif. 2021 Jan 01;168:110371
pubmed: 32904342
Int J Environ Res Public Health. 2020 Mar 06;17(5):
pubmed: 32155789
Sleep Med. 2020 Oct;74:18-24
pubmed: 32836181
J Clin Psychiatry. 2016 Oct;77(10):e1316-e1323
pubmed: 27788313
J Med Internet Res. 2020 Jun 17;22(6):e20185
pubmed: 32519963
Sleep. 2015 Feb 01;38(2):259-65
pubmed: 25515115
Arch Psychiatr Nurs. 2009 Oct;23(5):343-50
pubmed: 19766925
Psychiatry Res. 2020 Aug;290:113128
pubmed: 32563951
Stat Med. 2011 Aug 30;30(19):2389-408
pubmed: 21751231
Innov Clin Neurosci. 2014 Sep;11(9-10):93-140
pubmed: 25520892
Sleep Med. 2020 Oct;74:81-85
pubmed: 32841849
JAMA Netw Open. 2020 Mar 2;3(3):e203976
pubmed: 32202646
Med Clin (Barc). 2021 Feb 26;156(4):172-176
pubmed: 33243419
Ann Intern Med. 2015 Aug 4;163(3):191-204
pubmed: 26054060
Int J Environ Res Public Health. 2020 Jun 07;17(11):
pubmed: 32517294
JAMA Psychiatry. 2022 Jan 1;79(1):33-41
pubmed: 34817561
J Gen Intern Med. 2001 Sep;16(9):606-13
pubmed: 11556941
Sleep Med Rev. 2019 Feb;43:96-105
pubmed: 30537570
J Clin Sleep Med. 2016 Oct 15;12(10):1373-1378
pubmed: 27568895
Sleep. 2009 Aug;32(8):1027-37
pubmed: 19725254
Sleep Med Rev. 2015 Jun;21:50-8
pubmed: 25193149
Sleep. 2016 Feb 01;39(2):449-56
pubmed: 26446111
Sleep. 1987 Feb;10(1):45-56
pubmed: 3563247
Sleep Med Rev. 2021 Dec;60:101556
pubmed: 34607184