Study Stopped
Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.
A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic
A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts
2 other identifiers
interventional
356
1 country
6
Brief Summary
The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2022
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2021
CompletedFirst Posted
Study publicly available on registry
December 3, 2021
CompletedStudy Start
First participant enrolled
April 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2024
CompletedJune 12, 2025
June 1, 2025
2.2 years
November 11, 2021
June 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Columbia-Suicide Severity Rating Scale(C-SSRS)
The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104.
Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104
Study Arms (2)
Experimental App + Treatment as Usual
EXPERIMENTALThis intervention will be for the treatment group
Other App + Treatment as Usual
EXPERIMENTALThis intervention will be for the control group
Interventions
Treatment as usual may include appointments with psychiatrists and other mental health clinicians, suicide risk assessment, supportive listening, crisis resources, clinician assessment, and referral to outpatient treatment.
Eligibility Criteria
You may qualify if:
- Ages ≥18 years old
- Patients recently hospitalized.
- Owns a smartphone.
- Willing and able to complete enrollment procedures.
- Able to understand the nature of the study.
- Able and willing to provide at least two verifiable contacts.
You may not qualify if:
- Patients who have untreated psychosis or active psychosis
- Patients who appear to be impaired by the use of alcohol or other substance(s)
- Patients who sign, or have signed, an informed consent form to participate in any clinical research
- Patients who upon clinical examination are cognitively impaired
- Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oui Therapeutics, Inc.lead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (6)
UCDDenver / Denver Health
Denver, Colorado, 80204, United States
Yale
New Haven, Connecticut, 06511, United States
Common Spirit
Omaha, Nebraska, 68131, United States
Northwell Health
Glen Oaks, New York, 11004, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
Harding Hospital
Columbus, Ohio, 43210, United States
Related Publications (1)
Bryan CJ, Simon P, Wilkinson ST, Allen MH, Perez J, Adler C, Moon K, Astorino L, Carpenter KM, Misquitta L, Brownlowe K, Khazem LR, Hay J, Starkey AG, Tartaglia J, Winston H, Simpson S, Dager AD, Feuerstein S. A Digital Therapeutic Intervention for Inpatients With Elevated Suicide Risk: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2525809. doi: 10.1001/jamanetworkopen.2025.25809.
PMID: 40779267DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants and research assessors will be blinded to treatment assignment.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2021
First Posted
December 3, 2021
Study Start
April 7, 2022
Primary Completion
June 14, 2024
Study Completion
June 14, 2024
Last Updated
June 12, 2025
Record last verified: 2025-06