Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition

Conditions
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Cognitive Behavioral Therapy

Intervention / Treatment
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* Behavioral: cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: nurses with post COVID-19 condition Exclusion Criteria: history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cognitive behavioral therapy<br>6 weeks cognitive-behavioral therapy for insomnia | Behavioral: cognitive behavioral therapy<br>* 6 weeks cognitive behavioral therapy<br>|
| No Intervention: treat as usual<br>provide usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 20 weeks | 
| sleep quality | measured by Pittsburgh Sleep Quality Index | 20 weeks | 
| sleep efficiency | measured by Fitbit Charge 5 | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety | measured by Generalized Anxiety Disorder 7-Item | 20weeks | 
| depression | measured by Patient Health Questionnaire 9 item | 20weeks | 
| health-related quality of life | measured by 36-Item Short Form Health Survey | 20weeks |