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Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition (CBT-I)

Primary Purpose

Cognitive Behavioral Therapy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cognitive behavioral therapy
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Behavioral Therapy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: nurses with post COVID-19 condition Exclusion Criteria: history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    cognitive behavioral therapy

    treat as usual

    Arm Description

    6 weeks cognitive-behavioral therapy for insomnia

    provide usual care

    Outcomes

    Primary Outcome Measures

    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
    sleep quality
    measured by Pittsburgh Sleep Quality Index
    sleep efficiency
    measured by Fitbit Charge 5

    Secondary Outcome Measures

    anxiety
    measured by Generalized Anxiety Disorder 7-Item
    depression
    measured by Patient Health Questionnaire 9 item
    health-related quality of life
    measured by 36-Item Short Form Health Survey

    Full Information

    First Posted
    August 25, 2023
    Last Updated
    August 25, 2023
    Sponsor
    Tri-Service General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06013085
    Brief Title
    Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
    Acronym
    CBT-I
    Official Title
    Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    July 31, 2026 (Anticipated)
    Study Completion Date
    July 31, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tri-Service General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Behavioral Therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    cognitive behavioral therapy
    Arm Type
    Experimental
    Arm Description
    6 weeks cognitive-behavioral therapy for insomnia
    Arm Title
    treat as usual
    Arm Type
    No Intervention
    Arm Description
    provide usual care
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive behavioral therapy
    Intervention Description
    6 weeks cognitive behavioral therapy
    Primary Outcome Measure Information:
    Title
    insomnia severity
    Description
    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
    Title
    sleep quality
    Description
    measured by Pittsburgh Sleep Quality Index
    Time Frame
    20 weeks
    Title
    sleep efficiency
    Description
    measured by Fitbit Charge 5
    Time Frame
    20 weeks
    Secondary Outcome Measure Information:
    Title
    anxiety
    Description
    measured by Generalized Anxiety Disorder 7-Item
    Time Frame
    20weeks
    Title
    depression
    Description
    measured by Patient Health Questionnaire 9 item
    Time Frame
    20weeks
    Title
    health-related quality of life
    Description
    measured by 36-Item Short Form Health Survey
    Time Frame
    20weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: nurses with post COVID-19 condition Exclusion Criteria: history of sleep apnea, narcolepsy, pregnant, seizure, with pacemaker
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yu-Mu Hsien, PhD
    Phone
    886-2-87923311
    Ext
    10552
    Email
    tsghirb@ndmctsgh.edu.tw

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Data available on request due to privacy/ethical restrictions

    Learn more about this trial

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

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