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NCT Number: NCT06013085

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

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • nurses with post COVID-19 condition

Exclusion criteria

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

Treatment and study plan

Cognitive behavioral therapy

Behavioral

6 weeks cognitive behavioral therapy

Primary outcomes

  1. insomnia severity

    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

  2. sleep quality

    Time frame: 20 weeks

    measured by Pittsburgh Sleep Quality Index

  3. sleep efficiency

    Time frame: 20 weeks

    measured by Fitbit Charge 5

Secondary outcomes

  1. anxiety

    Time frame: 20weeks

    measured by Generalized Anxiety Disorder 7-Item

  2. depression

    Time frame: 20weeks

    measured by Patient Health Questionnaire 9 item

  3. health-related quality of life

    Time frame: 20weeks

    measured by 36-Item Short Form Health Survey

Study contacts

Contact information is provided by the study sponsor or research team.

Yu-Mu Hsien, PhD

CONTACT

[email protected]

886-2-87923311 ext. 10552

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Acronym: CBT-I

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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