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| ID | Type | Description | Link |
|---|---|---|---|
| 2R42MH123357-02 | U.S. NIH Grant/Contract | View source |
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Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.
This double blind, randomized controlled trial will evaluate effectiveness of two digital interventions among 391 participants. Study participation will start when participants sign consent. Participants and research assessors will be blinded to treatment assignment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental App + Treatment as Usual | Experimental | This intervention will be for the treatment group |
|
| Other App + Treatment as Usual | Experimental | This intervention will be for the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTX-202 | Device | Experimental Pscyhoeducation and Intervention App |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCDDenver / Denver Health | Denver | Colorado | 80204 | United States | ||
| Yale |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40779267 | Derived | 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. |
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| ID | Term |
|---|---|
| D013406 | Suicide, Attempted |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Participants and research assessors will be blinded to treatment assignment.
| OTX-000 | Device | Other Pscyhoeducation App |
|
| Treatment as Usual | Behavioral | 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. |
|
|
| 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 |