Cognitive behavioral therapy
Behavioral6 weeks cognitive behavioral therapy
NCT Number: NCT06013085
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.
Trial opening soon.
Get Notified20 year–65 year
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
6 weeks cognitive behavioral therapy
Time frame: 20 weeks
measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention
Time frame: 20 weeks
measured by Pittsburgh Sleep Quality Index
Time frame: 20 weeks
measured by Fitbit Charge 5
Time frame: 20weeks
measured by Generalized Anxiety Disorder 7-Item
Time frame: 20weeks
measured by Patient Health Questionnaire 9 item
Time frame: 20weeks
measured by 36-Item Short Form Health Survey
Contact information is provided by the study sponsor or research team.
Tri-Service General Hospital (TSGH)
Other
Acronym: CBT-I
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