Suicidal Ideation, Suicide, Attempted
Conditions
Brief summary
The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.
Detailed description
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.
Interventions
DEVICEOTX-202
Experimental Pscyhoeducation and Intervention App
DEVICEOTX-000
Other Pscyhoeducation App
BEHAVIORALTreatment as Usual
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.
Sponsors
National Institute of Mental Health (NIMH)
Oui Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and research assessors will be blinded to treatment assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Ages ≥18 years old 2. Patients recently hospitalized. 3. Owns a smartphone. 4. Willing and able to complete enrollment procedures. 5. Able to understand the nature of the study. 6. Able and willing to provide at least two verifiable contacts.
Exclusion criteria
1. Patients who have untreated psychosis or active psychosis 2. Patients who appear to be impaired by the use of alcohol or other substance(s) 3. Patients who sign, or have signed, an informed consent form to participate in any clinical research 4. Patients who upon clinical examination are cognitively impaired 5. Patients with a medical condition that may compromise, interfere, limit, effect or reduce the subject's ability to complete
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Columbia-Suicide Severity Rating Scale(C-SSRS) | Screening, Week 4, Week 8, Week 12, Week 24, Week 52, Week 78, Week 104 | The C-SSRS will be used to assess change in suicide behaviors at 8 separate time points from screening period to Week 104. |
Countries
United States
Outcome results
None listed