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

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.

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