An interventional study of WellPATH-PREVENT and Optimized WellPATH-PREVENT in Suicide, Attempted, Suicidal Ideation and Depression, sponsored by Weill Medical College of Cornell University. Recruiting at 2 sites in United States. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Prevention
The goal of this project is to test whether WellPATH-PREVENT (a novel, mobile psychosocial intervention) improves a specific aspect of emotion regulation, i.e., cognitive reappraisal ability, and reduces suicide risk in middle-aged and older adults (50-90 years old) who have been discharged after a suicide-related hospitalization (i.e. for suicidal ideation or suicide attempt).
R61 Phase: In this "proof-of-concept" phase, interventionists will administer 12 weeks of WellPATH-PREVENT in 40 middle-aged and older adults who have been discharged after being hospitalized for suicidal ideation or suicide attempt. The interventionist will help the patient incorporate the appropriate data (i.e., triggers, negative emotions, cognitive reappraisal techniques) into the tablet, train the patients on how to use the tablet, and coach them during the 12 weeks. There will be 4 assessments: At study entry (admission/during hospitalization), hospital discharge, 6, and 12 weeks. An EEG will be conducted upon entry into the study, at Week 6, and at Week 12.
R33 Phase: 75 middle-aged and older adults who have been recently discharged after a hospitalization for suicidal ideation or attempt will be recruited and randomized to an optimized version of WellPATH-PREVENT (Week 6 and Week 12 duration based on R61 results) or to Attention Control-Usual Care with a tablet (AC-UC). There will be 5 assessments: At study entry (admission/during hospitalization), discharge, 6, 12 and 24 weeks. Participants who exit the study prior to completion will be invited to have an assessment before termination as close to the scheduled time point as possible. Psychiatrically re-hospitalized participants will not be dropped from the study but will have an additional assessment and will continue the assessments as scheduled based on their initial hospitalization.
281 studies on the registry are indexed under Suicide, Attempted; 91 are open to participants now.
This study's planned enrollment of 115 is below the median of 129 across 224 interventional studies indexed under Suicide, Attempted.
Browse Suicide, Attempted studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: WellPATH-PREVENT
Behavioral: Optimized WellPATH-PREVENT
The AC-UC group will parallel the delivery of the WellPATH-PREVENT intervention and will also include: a) meetings during hospitalization: a non-clinical member of the team will present the control tablet and explain its use; b) scheduled or requested meetings through zoom: to parallel the delivery of WellPATH-PREVENT. The tablet will still have a link to schedule a meeting with a non-clinician member of the team. The meetings will focus on issues that the patient may have in using the tablet. There will not be any therapeutic or psychological interaction between participants in the control group and the team. The experimental and the control group will also be under usual outpatient care, which is arranged during the hospitalization by the inpatient treatment team.
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.
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
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Time frame: Study Entry, Week 6, Week 12
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Time frame: Study Entry, Week 6, Week 12, Week 24
Change in Self-Reported Affect - R61
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.
Time frame: Study Entry, Week 6, Week 12
Change in Self-Reported Affect - R33
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.
Time frame: Study Entry, Week 6, Week 12, Week 24
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
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.
Time frame: Study Entry, Week 6, Week 12
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
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.
Time frame: Study Entry, Week 6, Week 12, Week 24
Change in Client Satisfaction with Treatment (CSQ) - R61
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.
Time frame: Week 6, Week 12
Change in Client Satisfaction with Treatment (CSQ) - R33
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.
Time frame: Week 6, Week 12, Week 24
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Time frame: Weekly from Study Entry to Week 12 (R61)
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Time frame: Weekly from Study Entry to Week 24
Plan to share: Yes — De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
Time frame: Data will be available as per NIH's data sharing policy.
Access criteria: Access criteria is determined by NIH and can be requested by applying online.
Data sharing details ↗ · nda.nih.gov
No publications or documents are linked to this record.
Started Apr 2022 (actual). Primary completion is estimated for Sep 2027, 65 months after the start.
Of 145 non-industry interventional studies with no phase under Suicide, Attempted, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 56. This study's planned 65 months is above that.
Counting every sponsor, half of 147 studies reached it within 37 months; a quarter within 20 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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