NCT05233800

mHealth for Breast Cancer Survivors With Insomnia

Testing mHealth Delivery of Cognitive Behavioral Therapy for Insomnia to Breast Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer Survivor
• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Faster Asleep Smart Speaker Program	Participants will receive a smart speaker device with a pre-loaded Faster Asleep program. Participants will be asked to engage with the program daily, either using the voice-activated speakers or an accompanying smart-phone app. The study duration is six-weeks and is completed individually using fully automated interaction to deliver components of cognitive behavioral therapy for insomnia.
BEHAVIORAL	Faster Asleep Website	Controls will have access to a website with information about CBT-I and breast cancer survivorship and will be told to engage with the website as desired. The content will be drawn from the education script that is programmed into the phone app accompanying the smart speaker program.

Timeline

• Start date: 2022-04-05
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2022-02-10
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

1 site across 1 country: United States