About this trial
Background: Neuropsychiatric conditions, such as insomnia, anxiety, depression, and pain are the most common symptoms experienced by nurses after acute infection of COVID-19. Although medication can assist nurses to improve these symptoms simultaneously in a short period of time, they are at risk of overuse of benzodiazepine hypnotics. Previous research supports the usefulness of cognitive behavioral therapy for insomnia (CBT-I) as self-management strategies in adults with insomnia, anxiety, depression, and pain. However, their effects on post COVID-19 condition have not been researched, and no previous head-to-head study compared the effects on these two approaches on insomnia and neuropsychiatric symptoms.
Aim: To investigate the effects of CBT-I on insomnia, anxiety, depression, and pain in nurses with post COVID-19 condition.
Methods: In this two-arm, parallel randomized controlled trial, 100 participants will be 1:1 randomly assigned to one of two groups (CBT-I and control). The intervention phase will last 6 weeks, followed by a three-month follow-up. Primary outcomes are insomnia severity and sleep quality, whereas anxiety, depression, pain, and health-related quality of life are secondary outcomes. These variables will be assessed before and after the intervention, and at 1, 2, and 3 months after the end of the intervention. Additionally, discontinuing benzodiazepine hypnotics will be measured at 3 months after the end of the intervention.
Discussion: This study will provide evidence of the effects of CBT-I on improving insomnia, anxiety, depression, and pain among nurses with post COVID-19 condition. Results could also enhance means by which to discontinue benzodiazepine hypnotics.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
nurses with post COVID-19 condition
Disqualifiers
history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
Trial design
Parallel
Treatments tested in this trial
cognitive behavioral therapy
Behavioral6 weeks cognitive behavioral therapy
Treatment groups
Trial outcomes
Primary outcomes
insomnia severity
measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention
sleep quality
measured by Pittsburgh Sleep Quality Index
sleep efficiency
measured by Fitbit Charge 5
Secondary outcomes
anxiety
measured by Generalized Anxiety Disorder 7-Item
depression
measured by Patient Health Questionnaire 9 item
health-related quality of life
measured by 36-Item Short Form Health Survey
Locations
Sponsors and contacts
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