Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
NCT ID: NCT06013085
Last Updated: 2023-08-28
Study Results
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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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2023-09-01
2026-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cognitive behavioral therapy
6 weeks cognitive-behavioral therapy for insomnia
cognitive behavioral therapy
6 weeks cognitive behavioral therapy
treat as usual
provide usual care
No interventions assigned to this group
Interventions
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cognitive behavioral therapy
6 weeks cognitive behavioral therapy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
65 Years
ALL
Yes
Sponsors
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Tri-Service General Hospital
OTHER
Responsible Party
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Wen-Chii Tzeng
Professor
Central Contacts
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Other Identifiers
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A202205210
Identifier Type: -
Identifier Source: org_study_id
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