Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876001
Status:
COMPLETED
Last Update Posted:
2024-04-23
First Post:
2021-03-28
Brief Title:
Nurse-Led BBTi for Post-stroke Insomnia
Sponsor:
Taipei Medical University
Organization:
Taipei Medical University
Study Overview
Official Title:
Effects of Nurse-Led Brief Behavioral Treatment for Insomnia Following Stroke A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-04
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:
None
Brief Summary:
The current study aims to compare face-to-face and internet-based nurse-led BBTI compare to a wait-list conditions in the stroke population This study is a parallel three-arm randomized controlled trial RCT Each participant will be randomized into one of the treatment arms face-to-face BBTI internet-based BBTI and waiting-list The BBTI emphasizes behavioral aspects of insomnia care arises from techniques of sleep restriction and stimulus control The face-to-face and internet-based BBTI have equivalent content based on the standard portion All participants will be asked to fill the online questionnaires at weeks 0 baseline 1 mid-treatment 2 post-treatment 4 and 12 follow up After the final follow-up the waiting-list participants will be allowed to join the internet-based BBTI treatment Our hypotheses are that patients with stroke who receive face-to-face or internet-based BBTI compared to a wait-list condition will experience fewer insomnia complaints
Detailed Description:
Post-stroke insomnia is a common complaint with prevalence rates remain high Patients suffering from insomnia following stroke could impair their health-related quality of life and negative rehabilitation outcomes Identifying effective treatment in managing post-stroke insomnia has become clinically relevant
Brief behavioral therapy for insomnia BBTI a 4-section of treatment for insomnia has similar treatment components with CBTI with the exception of cognitive therapy Previous evidence found that both BBTI and CBTI have comparable effects on improving sleep quality and consolidation Existing literature has suggested that BBTI was effective on mitigating primary and comorbid insomnia Nonetheless thus far no study has explored its effects in stroke population Of note BBTI still requires certain contact with therapists To enhance the widespread dissemination of BBTI it is important to establish the internet-based BBTI treatment model more flexible time schedule to target more populations with insomnia The recent study of the online tailored BBTI has proven the comparable effects to reduce insomnia severity in the general population However no study investigates the efficacy of internet-based nurse-led BBTI in the stroke population
Brief behavioral therapy for insomnia BBTI a 4-section of treatment for insomnia has similar treatment components with CBTI with the exception of cognitive therapy Previous evidence found that both BBTI and CBTI have comparable effects on improving sleep quality and consolidation Existing literature has suggested that BBTI was effective on mitigating primary and comorbid insomnia Nonetheless thus far no study has explored its effects in stroke population Of note BBTI still requires certain contact with therapists To enhance the widespread dissemination of BBTI it is important to establish the internet-based BBTI treatment model more flexible time schedule to target more populations with insomnia The recent study of the online tailored BBTI has proven the comparable effects to reduce insomnia severity in the general population However no study investigates the efficacy of internet-based nurse-led BBTI in the stroke population
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