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

Not Applicable
Not yet recruiting
Conditions
Cognitive Behavioral Therapy
Interventions
Behavioral: cognitive behavioral therapy
Registration Number
NCT06013085
Lead Sponsor
Tri-Service General Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • nurses with post COVID-19 condition
Exclusion Criteria
  • history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
cognitive behavioral therapycognitive behavioral therapy6 weeks cognitive-behavioral therapy for insomnia
Primary Outcome Measures
NameTimeMethod
sleep efficiency20 weeks

measured by Fitbit Charge 5

sleep quality20 weeks

measured by Pittsburgh Sleep Quality Index

insomnia severity20 weeks

measured by Insomnia Severity Index before and after the intervention, and at 1, 2, and 3 months after the end of the intervention

Secondary Outcome Measures
NameTimeMethod
depression20weeks

measured by Patient Health Questionnaire 9 item

anxiety20weeks

measured by Generalized Anxiety Disorder 7-Item

health-related quality of life20weeks

measured by 36-Item Short Form Health Survey

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