A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2024-06-14

Brief Summary

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The primary objective of this study is to assess the effectiveness of a digital intervention in reducing suicide attempts.

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Detailed Description

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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.

Conditions

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Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants and research assessors will be blinded to treatment assignment.

Study Groups

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Experimental App + Treatment as Usual

This intervention will be for the treatment group

Group Type EXPERIMENTAL

OTX-202

Intervention Type DEVICE

Experimental Pscyhoeducation and Intervention App

Treatment as Usual

Intervention Type 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.

Other App + Treatment as Usual

This intervention will be for the control group

Group Type EXPERIMENTAL

OTX-000

Intervention Type DEVICE

Other Pscyhoeducation App

Treatment as Usual

Intervention Type 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.

Interventions

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OTX-202

Experimental Pscyhoeducation and Intervention App

Intervention Type DEVICE

OTX-000

Other Pscyhoeducation App

Intervention Type DEVICE

Treatment 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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TAU

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes