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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
A software application targeting suicidal ideation via interactive exercises.
Yale-New Haven Hospital
New Haven, Connecticut, United States
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.
Time frame: 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?
Time frame: 16 weeks
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.
Time frame: 16 weeks
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 16 weeks
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.
Time frame: 1 week
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.
Time frame: 16 weeks
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.
Time frame: 16 weeks