Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06434571
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-23
Brief Title:
Comparing Telehealth-Delivered CBT-I to Web-Based CBT-I to Enhance Sleep Reduce Fatigue and Promote Neuroprotection
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Comparing Telehealth-Delivered Cognitive Behavioral Therapy for Insomnia to Web-Based to Enhance Sleep Reduce Fatigue and Promote Neuroprotection
Status:
RECRUITING
Status Verified Date:
2024-10
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:
CLEAR
Brief Summary:
The objective of this RCT is to assess the efficacy of one-on-one telehealth CBT-I tCBT-I compared to web-based CBT-I wCBT-I and treatment as usual TAU to improve sleep outcomes Aim 1 fatigue and quality of life Aim 2 and promote neuroprotection Exploratory Aim 3 and to explore the characteristics of participants that predict improvement in sleep outcomes Exploratory Aim 4 Reassessment of outcomes will be completed after the 6-week intervention and 6 months following completion of interventions
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