Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04919993
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2021-05-24
Brief Title:
CBT for Insomnia in Primary Brain Tumor Patients
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Cognitive Behavioral Therapy for Insomnia in Primary Brain Tumor Patients
Status:
COMPLETED
Status Verified Date:
2023-01
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 purpose of this study is to pilot test an empirically supported psychotherapeutic intervention Cognitive Behavior Therapy for Insomnia CBT-I in primary brain tumor patients Researchers hope to better understand the feasibility and acceptability of this intervention in neuro-oncology as well as the preliminary potential benefits of this intervention on brain tumor patients sleep fatigue mood quality of life and chronic inflammation This may lead to improvements in treating insomnia in primary brain tumor patients
Detailed Description:
The present study design is a pilot within-subjects pre-post-evaluation of feasibility acceptability and preliminary efficacy of the Cognitive Behavioral Therapy for Insomnia CBT-I intervention for primary brain tumor patients In this study participants will be asked to do the following things
Meet with a trained interventionist six times biweekly for group CBT-I sessions via Zoom lasting 90 minutes each Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention
Complete 20-minute online surveys before the program immediately after the program 6 weeks and at follow-up 3 months Questions will ask about subjective sleep fatigue mood and quality of life The follow-up time point will also ask about the patients satisfaction with the CBT-I program
Complete a brief 15 minute cognitive evaluation before and immediately following the program
Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention
Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention
Meet with a trained interventionist six times biweekly for group CBT-I sessions via Zoom lasting 90 minutes each Participants will be asked to only use first names and will complete weekly sleep diaries as part of the intervention
Complete 20-minute online surveys before the program immediately after the program 6 weeks and at follow-up 3 months Questions will ask about subjective sleep fatigue mood and quality of life The follow-up time point will also ask about the patients satisfaction with the CBT-I program
Complete a brief 15 minute cognitive evaluation before and immediately following the program
Wear a wrist-worn actigraphy monitor one week prior to the 6-week CBT-I intervention and one week following completion of the intervention
Patients currently receiving regular blood draws as part of their care at Massey Cancer Center will have an IL-6 added to their regular blood draw THose who are not receiving regular blood draws as part of their standard of care OR those who are not patients at Massey Cancer Center will forego this part of the intervention
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