Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06013085
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-28
First Post:
2023-08-25
Brief Title:
Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
Sponsor:
Tri-Service General Hospital
Organization:
Tri-Service General Hospital
Study Overview
Official Title:
Effects of Cognitive-behavioral Therapy for Insomnia in Nurses With Post Covid-19 Condition
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBT-I
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 11 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
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 11 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None