NCT05813392

Digital Cognitive Behavioral Therapy for Insomnia for Chronic Insomnia in Breast Cancer Survivors

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) for Chronic Insomnia in Breast Cancer Survivors, A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Digital Cognitive Behavioral Therapy for Insomnia	a full self-help digital cognitive behavioral therapy for Insomnia (dCBT-I) through a smartphone APP

Timeline

• Start date: 2023-08-29
• Primary completion: 2025-08-29
• Completion: 2026-08-29
• First posted: 2023-04-14
• Last updated: 2024-10-22

Locations

1 site across 1 country: China