WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt

BEHAVIORAL

WellPATH-PREVENT

WellPATH-PREVENT is a novel personalized, easy to use, mainly stand-alone mobile intervention which focuses on the exclusive use of the WellPATH tablet app and includes training meetings during hospitalization, and virtual post-discharge coaching meetings. The meetings aim to: a) identify stressors and triggers of negative emotions associated with increased suicidal ideation or with suicidal behavior; b) develop techniques (text or video) to increase cognitive reappraisal ability; c) incorporate the techniques into the WellPATH app and promote the use of WellPATH during stressful incidents, triggers of negative emotions, or scheduled brief training sessions; and d) remotely update the triggers, negative emotions, and techniques in the app.

BEHAVIORAL

Optimized WellPATH-PREVENT

The Optimized WellPATH-PREVENT intervention will be as described above, but based on the results of the Proof-of-Concept (R61) Phase, an expert committee will help select the duration (6 or 12 weeks) that shows greater improvement in cognitive reappraisal.

Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61

Time frame: Study Entry, Week 6, Week 12

ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.

Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33

Time frame: Study Entry, Week 6, Week 12, Week 24

ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.

Change in Self-Reported Affect - R61

Time frame: Study Entry, Week 6, Week 12

Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.

Change in Self-Reported Affect - R33

Time frame: Study Entry, Week 6, Week 12, Week 24

Self-reported affect is used to study changes in negative emotions during an EEG emotion regulation task. It is based on a participant's rating of negative emotions (Likert scale: 1-5; 5 most negative) during the task.

Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61

Time frame: Study Entry, Week 6, Week 12

ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.

Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33

Time frame: Study Entry, Week 6, Week 12, Week 24

ERQ is an interviewer-administered instrument to evaluate cognitive reappraisal ability. Scores can range from 1-7, where higher scores indicate greater use of emotion regulation strategies and lower scores indicate less frequent use of such strategies.

Change in Client Satisfaction with Treatment (CSQ) - R61

Time frame: Week 6, Week 12

Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.

Change in Client Satisfaction with Treatment (CSQ) - R33

Time frame: Week 6, Week 12, Week 24

Client Satisfaction Questionnaire is a self-report that measures patient satisfaction with intervention/treatment. Scores can range from 3-12, where higher values indicate higher satisfaction.

Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61

Time frame: Weekly from Study Entry to Week 12 (R61)

C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.

Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33

Time frame: Weekly from Study Entry to Week 24

C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.