Clinical trial · Interventional
BNT001 Digital Therapeutic Feasibility Pilot Study
Phase II Pilot Study Evaluating the Feasibility of Delivery and Evaluation of BNT001, a Digital Cognitive-Behavioral Stress Management (CBSM) Software Application for Treatment of Anxiety and Depressive Symptoms in Veterans With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): recruitment challenges
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BNT001 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BNT001
- description
- BNT001 is a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant's mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients.
- interventionNames
- Device: BNT001
Primary outcomes (2)
- measure
- Identification of promoters and barriers to clinical implementation
- timeFrame
- Baseline to 4 weeks
- description
- Identification of promoters and barriers to clinical implementation of BNT001, a software application that delivers a 10-session, cancer-specific, behavioral intervention called Cognitive-Behavioral Stress Management (CBSM), to adult patients currently undergoing cancer treatment.
- measure
- To measure changes in pre and post cancer-related distress in patient participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available