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
About this trial
This is an interventional treatment trial for Cognitive Behavioral Therapy
Eligibility Criteria
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
NCT ID
NCT06013085
First Posted
August 25, 2023
Last Updated
August 25, 2023
Sponsor
Tri-Service General Hospital
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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