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

Not Applicable

Completed

• Conditions: Suicidal Ideation; Suicide, Attempted
• Interventions: Device: Software Application

• Registration Number: NCT04295382
• Lead Sponsor: Oui Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-02
• Study First Posted: 2020-03-04
• Study Start: 2020-05-12
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-18
• Last Update Posted: 2022-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Software Application	Software Application	-

Primary Outcome Measures

Name	Time	Method
System Usability Scale (SUS)	16 weeks	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	16 weeks	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

Name	Time	Method
Suicidal ideation	16 weeks	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	16 weeks	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	1 week	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	16 weeks	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	16 weeks	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.

Trial Locations

Locations (1)

Yale-New Haven Hospital; 🇺🇸 New Haven, Connecticut, United States