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

Primary Purpose

Suicide, Attempted, Suicidal Ideation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Software Application
Sponsored by
Oui Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Suicide, Attempted

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yale-New Haven Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Software Application

Arm Description

Outcomes

Primary Outcome Measures

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.
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?

Secondary Outcome Measures

Suicidal ideation
The Beck Scale for Suicidal Ideation (BSS) is a 21-item self or clinician administered instrument used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Suicide attempts and other behaviors
This outcome will be assessed via the Columbia Suicide Severity Rating Scale (CSSRS), which was designed to classify suicide attempts, aborted suicide attempts, and other suicidal behaviors. Intensity of Ideation Subscale - includes 5 questions about the Frequency, Duration, Controllability, Deterrents, and Reasons for Ideation for the most severe level of ideation endorsed on the Severity subscale (i.e., highest endorsed from 1 to 5). The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk. Suicidal Behavior Lethality inquires about the level of actual medical damage or potential for it. Greater lethality or potential lethality of the behavior (endorsed on the Behavior subscale) indicates increased risk.
Diagnostic interview
The Mini International Neuropsychiatric Interview Neurocognitive (MINI) (40): this is a widely used, structured diagnostic interview that will be used to verify diagnosis at the screening visit.
Adverse events
The Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI): This is a self-rated questionnaire assessing possible adverse events during the course of the trial. The purpose of the SAFTEE-SI is analytical and evaluates adverse events on a study level.
Depressive symptoms
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report form to assess the severity of depressive symptoms that has been widely used in practice and research. This will be used throughout the study to assess severity of any depressive symptoms each participants is experiencing. The possible range is 0-27. Minimal depression (0-4). ≤ 4 The score suggests the patient may not need depression treatment. Mild depression (5-9). Moderate depression (10-14). 5 - 14 Physician uses clinical judgment about treatment, based on patient's duration of symptoms and functional impairment. Moderately severe depression (15-19). Severe depression (20-27). > 14 Warrants treatment for depression, using antidepressant, psychotherapy and/or a combination of treatment.

Full Information

First Posted
March 2, 2020
Last Updated
April 18, 2022
Sponsor
Oui Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04295382
Brief Title
Feasibility Study of a Software Application for Patients Hospitalized After Suicidal Ideation or Suicide Attempts
Official Title
An Open-Label, Study of the Feasibility and the Usability of a Software Application to Deliver Targeted Interactive Exercises, in Addition to Treatment as Usual, to Patients Recently Hospitalized for Suicidal Ideation or Suicide Attempts
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oui Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Software Application
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Software Application
Intervention Description
A software application targeting suicidal ideation via interactive exercises.
Primary Outcome Measure Information:
Title
System Usability Scale (SUS)
Description
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.
Time Frame
16 weeks
Title
User Feedback Interview Questions
Description
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?
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Suicidal ideation
Description
The Beck Scale for Suicidal Ideation (BSS) is a 21-item self or clinician administered instrument used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.
Time Frame
16 weeks
Title
Suicide attempts and other behaviors
Description
This outcome will be assessed via the Columbia Suicide Severity Rating Scale (CSSRS), which was designed to classify suicide attempts, aborted suicide attempts, and other suicidal behaviors. Intensity of Ideation Subscale - includes 5 questions about the Frequency, Duration, Controllability, Deterrents, and Reasons for Ideation for the most severe level of ideation endorsed on the Severity subscale (i.e., highest endorsed from 1 to 5). The total score ranges from 2 to 25, with a higher number indicating more intense ideation and greater risk. Suicidal Behavior Lethality inquires about the level of actual medical damage or potential for it. Greater lethality or potential lethality of the behavior (endorsed on the Behavior subscale) indicates increased risk.
Time Frame
16 weeks
Title
Diagnostic interview
Description
The Mini International Neuropsychiatric Interview Neurocognitive (MINI) (40): this is a widely used, structured diagnostic interview that will be used to verify diagnosis at the screening visit.
Time Frame
1 week
Title
Adverse events
Description
The Systematic Assessment for Treatment Emergent Effects-Systematic Inquiry (SAFTEE-SI): This is a self-rated questionnaire assessing possible adverse events during the course of the trial. The purpose of the SAFTEE-SI is analytical and evaluates adverse events on a study level.
Time Frame
16 weeks
Title
Depressive symptoms
Description
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report form to assess the severity of depressive symptoms that has been widely used in practice and research. This will be used throughout the study to assess severity of any depressive symptoms each participants is experiencing. The possible range is 0-27. Minimal depression (0-4). ≤ 4 The score suggests the patient may not need depression treatment. Mild depression (5-9). Moderate depression (10-14). 5 - 14 Physician uses clinical judgment about treatment, based on patient's duration of symptoms and functional impairment. Moderately severe depression (15-19). Severe depression (20-27). > 14 Warrants treatment for depression, using antidepressant, psychotherapy and/or a combination of treatment.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sam Wilkinson, M.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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