@Article{info:doi/10.2196/34409,
author="O'Hora, Kathleen Patricia
and Osorno, Raquel A
and Sadeghi-Bahmani, Dena
and Lopez, Mateo
and Morehouse, Allison
and Kim, Jane P
and Manber, Rachel
and Goldstein-Piekarski, Andrea N",
title="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",
journal="JMIR Res Protoc",
year="2022",
month="Mar",
day="14",
volume="11",
number="3",
pages="e34409",
keywords="insomnia; COVID-19; pandemic; telehealth; cognitive behavioral therapy; CBT-I; sleep; depression; well-being; telemedicine; impact; mental health; therapy",
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://clinicaltrials.gov/ct2/show/NCT04409743 International Registered Report Identifier (IRRID): DERR1-10.2196/34409 ",
issn="1929-0748",
doi="10.2196/34409",
url="https://www.researchprotocols.org/2022/3/e34409",
url="https://doi.org/10.2196/34409",
url="http://www.ncbi.nlm.nih.gov/pubmed/34995204"
}