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

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

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 li...

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Bibliographic Details
Published in:JMIR research protocols Vol. 11; no. 3; p. e34409
Main Authors: O'Hora, Kathleen Patricia, Osorno, Raquel A, Sadeghi-Bahmani, Dena, Lopez, Mateo, Morehouse, Allison, Kim, Jane P, Manber, Rachel, Goldstein-Piekarski, Andrea N
Format: Journal Article
Language:English
Published: Canada JMIR Publications 14-03-2022
Subjects:
Anxiety
Behavior modification
Cognitive therapy
Coronaviruses
COVID-19
Feasibility studies
Insomnia
Intervention
Medical research
Mental depression
Mental disorders
Mental health
Pandemics
Protocol
Quality of life
Research methodology
Risk factors
Screen time
Sleep
Stress
Telemedicine
cognitive behavioral therapy
telemedicine
well-being
mental health
therapy
impact
pandemic
insomnia
COVID-19
sleep
telehealth
depression
CBT-I
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Summary: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.
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ISSN:1929-0748
1929-0748
DOI:10.2196/34409