Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04896775
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2021-05-05
Brief Title:
NiteCAPP Web-based Interventions for Insomnia in Rural Dementia Caregivers
Sponsor:
University of South Florida
Organization:
University of South Florida
Study Overview
Official Title:
NiteCAPP Web-based Interventions for Insomnia in Rural Dementia Caregivers Examination of Sleep Arousal Mood Cognitive and Immune Outcomes
Status:
RECRUITING
Status Verified Date:
2024-03
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:
NiteCAPP
Brief Summary:
The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample n of 100 caregiver and PWD dyads We will measure both the short term post-treatment and long term 6 and 12 months effects of the intervention on CG sleep arousal inflammation health mood burden and cognitive function and PWD sleep
Detailed Description:
Over the next 30 years more than 10 million persons living with dementia in the US will receive care at home from an unpaid and untrained family caregiver At home care is preferred by caregivers CG and persons with dementia PWD alike but increases caregiver risk of insomnia and related negative health outcomes including depression anxiety cognitive disturbances and poor quality of life Cognitive behavioral therapy for insomnia CBT-I is an effective and established evidence based treatment for adults of all ages Although relatively understudied in dementia caregivers the research suggests CBT-I is also efficacious in caregivers Our team developed a brief 4 session CBT-I protocol adapted for dementia caregivers and has shown in person and remote ie telehealth delivery of this protocol significantly reduces insomnia and improves mood moderate to large effects Given demands on caregiver time and limited availability of trained CBT-I providers we developed a web-based version of this treatment NiteCAPP to increase accessibility of this efficacious treatment for rural dementia CGs NiteCAPP will allow for flexible at home scheduling and the skills needed to monitor caregiver treatment progress can be quickly and efficiently taught to healthcare providers The Cognitive Activation Theory of Stress provides a framework for our basic premise that CGs experience insomnia arousal and inflammation that prompt sympathetic activation and hypothalamic-pituitary-adrenal HPA disruption that have negative effects on health The proposed trial tests the novel hypothesis that NiteCAPP will improve CG health mood burden and cognition by targeting their shared mechanisms - sleep arousal and inflammation - thereby returning sympathetic and HPA functioning to normal Another novel aspect of the proposed trial is inclusion of behavioral strategies to target the PWD sleep Objectives The goal of this project evaluate the efficacy of NiteCAPP in improving insomnia in a rural dementia caregiver sample n of 100 caregiver and PWD dyads We will measure both the short term post-treatment and long term 6 and 12 months effects of the intervention on CG sleep arousal inflammation health mood burden and cognitive function and PWD sleep
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