BNT001 Digital Therapeutic Feasibility Pilot Study
Stopped early · Not applicable
Conditions studied: Cancer
In brief
This single arm phase II trial focused on cancer patients and cancer survivors in the Veterans Health Administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of BNT001, a prescription digital software application. BNT001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.
Key facts
- Study ID
- NCT04857008
- Run by
- Blue Note Therapeutics
- People needed
- 17
- Starts
- 2021-10-08
- Expected to finish
- 2022-08-05
- Last updated by the study team
- 2022-10-20
Who can join
Age: 17 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis or history of invasive cancer (excluding non-melanoma skin cancer).
- Patients showing mild to moderate anxiety or depression on the Veteran System Assessment Screen (VSAS), with anxiety or depression scored as 1-6 on a 0-10 scale.
- Fluent in English.
- Has access to iOS or Android smartphone, or tablet and capable of receiving text messages.
- Has an e-mail address.
You may not qualify if…
- Endorses thoughts of self-harm, history of suicidality.
- Currently participating in investigative behavioral intervention trial for treatment of anxiety or depression.
- Participant is unable to complete training, has cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to reliable internet and accessible device; other social conditions that would interfere with adherence to self directed care, such that in investigator's opinion the participant would be unable to complete the study.
- Recently completed use of Blue Note Therapeutics COVID Cancer Care Program or other Blue Note Therapeutics sponsored study.
Where it is running
- Durham Veterans Administration — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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