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

NCT ID: NCT06013085

Last Updated: 2023-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-07-31

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.

Detailed Description

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Conditions

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Cognitive Behavioral Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cognitive behavioral therapy

6 weeks cognitive-behavioral therapy for insomnia

Group Type EXPERIMENTAL

cognitive behavioral therapy

Intervention Type BEHAVIORAL

6 weeks cognitive behavioral therapy

treat as usual

provide usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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cognitive behavioral therapy

6 weeks cognitive behavioral therapy

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen-Chii Tzeng

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yu-Mu Hsien, PhD

Role: CONTACT

886-2-87923311 ext. 10552

Other Identifiers

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A202205210

Identifier Type: -

Identifier Source: org_study_id

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