Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-29 @ 6:55 PM
Study NCT ID:
NCT05233800
Status:
COMPLETED
Last Update Posted:
2025-01-24
First Post:
2022-01-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
mHealth for Breast Cancer Survivors With Insomnia
Sponsor:
Medstar Health Research Institute
Organization:
Study Overview
Official Title:
Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2024-12
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 aim of this study is to determine the impact of the voice-activated smart speaker CBT-I components on insomnia symptoms among breast cancer survivors using a randomized clinical trial.
Detailed Description:
This study is a Phase II SBIR to further test efficacy of a voice-activated technology to deliver components of cognitive behavioral therapy for insomnia (CBT-I) to breast cancer survivors (BCS) compared to a web-based control. Participants will be randomly assigned to the voice-activated or web-based treatment arms and will complete a 6-week intervention.
Study Oversight
Has Oversight DMC:
False
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?: