NCT04295382

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

March 2, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

May 12, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

March 2, 2020

Last Update Submit

April 18, 2022

Conditions

Suicide, AttemptedSuicidal Ideation

Outcome Measures

Primary Outcomes (2)

  • System Usability Scale (SUS)

    The SUS is a valid and reliable, 10-item measure that effectively differentiates between usable and unusable systems. Sample items are "I think that I would like to use this app frequently" and "I felt very confident using the system." Responses are rated using a 5-point (strongly disagree to strongly agree) Likert scale. Scores range from 0 to 100, with a score of 68 being minimal indicator of usability.

    16 weeks

  • User Feedback Interview Questions

    Participants will answer the following questions. 1) What did you think about this experience? 2) Do you think you would use this app again if needed? Why (not)? 3) Do you think this app would be useful for helping you with your suicidal thoughts and preventing you from acting on them? Why (not)? Did you think functions were missing in the app? Which ones? 4) Is there anything else you think we should know to make this app better and more user-friendly?

    16 weeks

Secondary Outcomes (5)

  • Suicidal ideation

    16 weeks

  • Suicide attempts and other behaviors

    16 weeks

  • Diagnostic interview

    1 week

  • Adverse events

    16 weeks

  • Depressive symptoms

    16 weeks

Study Arms (1)

Software Application

EXPERIMENTAL
Device: Software Application

Interventions

Software ApplicationDEVICE

A software application targeting suicidal ideation via interactive exercises.

Software Application

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale-New Haven Hospital

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Suicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Sam Wilkinson, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2020

First Posted

March 4, 2020

Study Start

May 12, 2020

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)