Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
Study NCT ID:
NCT05813392
Status:
RECRUITING
Last Update Posted:
2024-10-22
First Post:
2022-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors
Sponsor:
Peking University First Hospital
Organization:
Study Overview
Official Title:
Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial
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:
None
Brief Summary:
To explore the efficacy of dCBT-I therapy for chronic insomnia among breast cancer survivors in China, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone Chinese application (app) "resleep". Breast cancer survivors with chronic insomnia were recruited from our Breast Disease Center and externally, with the waiting group as a parallel control and the dCBT-I treatment group as an intervention group, in a 1:1 sample size. Intervention group (dCBT-I treatment group) will receive full self-help dCBT-I administered by smartphone APP for 6 weeks. The control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.At the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. The primary endpoint was the insomnia severity index (ISI) at the end of treatment and at 3 months of treatment.
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?: