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

Suicidal Ideation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04295382
• Other study ID #: OUI-AVI-BT3
• Status: Completed
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: April 2022
• Source: Oui Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Device:
• Software Application
A software application targeting suicidal ideation via interactive exercises.

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Oui Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	16 weeks
Secondary	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.	16 weeks
Secondary	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.	1 week
Secondary	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.	16 weeks
Secondary	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.	16 weeks