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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorTri-Service General Hospital

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 volunteers

Qualifiers

nurses with post COVID-19 condition

Disqualifiers

history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Trial design

Design model

Parallel

Treatments tested in this trial

  • cognitive behavioral therapy

    Behavioral

    6 weeks cognitive behavioral therapy

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: cognitive behavioral therapyExperimental treatment 1 intervention
Group B: treat as usualNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
20 weeks
2

sleep quality

measured by Pittsburgh Sleep Quality Index

Time frame
20 weeks
3

sleep efficiency

measured by Fitbit Charge 5

Time frame
20 weeks

Secondary outcomes

1

anxiety

measured by Generalized Anxiety Disorder 7-Item

Time frame
20weeks
2

depression

measured by Patient Health Questionnaire 9 item

Time frame
20weeks
3

health-related quality of life

measured by 36-Item Short Form Health Survey

Time frame
20weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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