Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2026-04-13 @ 7:09 PM
Study NCT ID:
NCT06060158
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2023-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Internet Group CBT-I for Gyn Oncology Patients
Sponsor:
University of California, Davis
Organization:
Study Overview
Official Title:
Feasibility of Internet-Delivered Group Cognitive Behavioral Therapy for Insomnia in Gynecologic Oncology Patients
Status:
COMPLETED
Status Verified Date:
2025-01
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 goal of this study is to evaluate the feasibility and acceptability of delivering cognitive behavioral therapy for insomnia (CBT-I) to gynecologic cancer patients in an internet-based small-group setting.
Secondary objectives:
1. To compare insomnia symptoms before and after intervention.
2. To evaluate any changes in quality of life symptoms while undergoing the intervention.
3. To evaluate the duration of symptoms improvement after the intervention is complete.
Secondary objectives:
1. To compare insomnia symptoms before and after intervention.
2. To evaluate any changes in quality of life symptoms while undergoing the intervention.
3. To evaluate the duration of symptoms improvement after the intervention is complete.
Detailed Description:
This is a pilot feasibility study looking at delivering CBT-I to gynecologic cancer patients. This study will be completed via a novel internet based small group platform. Twelve eligible participants will meet weekly for 6 weeks while undergoing the CBT-I program.
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?: