Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts

NCT ID: NCT04295382

Last Updated: 2022-04-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2021-07-01

Brief Summary

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The primary objective of this feasibility study is to assess the feasibility, and usability of a software application to deliver targeted interactive exercises to patients recently hospitalized for suicidal ideation or suicide attempts.

Detailed Description

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Conditions

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Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Software Application

Group Type EXPERIMENTAL

Software Application

Intervention Type DEVICE

A software application targeting suicidal ideation via interactive exercises.

Interventions

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Software Application

A software application targeting suicidal ideation via interactive exercises.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* English speaking male or female patients, 18-70 years
* Patients who have attempted suicide and voluntarily admitted themselves to an inpatient psychiatric unit or have clinically significant suicidal ideation and intent to harm themselves and are still on the inpatient psychiatric unit.
* Understand written and spoken English
* Own an iPhone with iOS 11 or higher, or Android with OS 8.1 or higher
* Willing and able to complete enrollment procedures
* Able to understand the nature of the study and provide written informed consent
* Able and willing to provide at least two verifiable contacts for emergency or tracking purposes.

Exclusion Criteria

* Patients with active psychosis
* Patients who are acutely intoxicated at the time of enrollment
* Currently enrolled in other treatment studies for the symptoms and behaviors targeted
* Patients who are cognitively impaired
* Patients who, in the judgment of the investigator, would have an unfavorable risk/benefit (e.g. critically ill patients) profile with respect to the software application that delivers interactive exercises.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oui Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sam Wilkinson, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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OUI-AVI-BT3

Identifier Type: -

Identifier Source: org_study_id

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