Recruiting

WellPATH-PREVENT

Sponsor:

Weill Medical College of Cornell University

Code:

NCT05183230

Conditions

Suicide, Attempted

Suicidal Ideation

Depression

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

WellPATH-PREVENT

Optimized WellPATH-PREVENT

Study Details

Brief summary:

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).

Conditions

Suicide, Attempted

Suicidal Ideation

Depression

Study ID

NCT05183230

Start date

Apr 22, 2022

Status verified date

Oct, 2025

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 50-90 years old
  • Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5 diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis of Dementia
  • Recent hospitalization for suicidal ideation or suicide attempt; at hospital admission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific Active Suicidal Thoughts."
  • We will also include patients on psychotropics and on after-care community psychotherapy.

Exclusion Criteria:

  • Current diagnosis of Psychotic Disorders; Diagnosis of Dementia
  • Cognitive Impairment (MMSE ≤ 24)
  • Acute or severe medical illness (i.e., delirium; decompensated cardiac, liver or kidney failure; major surgery; stroke or myocardial infarction during the three months prior to entry
  • Aphasia, sensory problems, and/or inability to speak English.

Study Design

Enrollment

115 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Proof-of-Concept WellPATH-PREVENT (R61)

experimental: Optimized WellPATH-PREVENT (R33)

no intervention: Attention Control Usual Care (R33)

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.

Interventions

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.

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.

Primary outcome measure

  • Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61 [ Time Frame: Study Entry, Week 6, Week 12 ]
  • Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33 [ Time Frame: Study Entry, Week 6, Week 12, Week 24 ]
  • Change in Self-Reported Affect - R61 [ Time Frame: Study Entry, Week 6, Week 12 ]
  • Change in Self-Reported Affect - R33 [ Time Frame: Study Entry, Week 6, Week 12, Week 24 ]
  • Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61 [ Time Frame: Study Entry, Week 6, Week 12 ]
  • Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33 [ Time Frame: Study Entry, Week 6, Week 12, Week 24 ]
  • Change in Client Satisfaction with Treatment (CSQ) - R61 [ Time Frame: Week 6, Week 12 ]
  • Change in Client Satisfaction with Treatment (CSQ) - R33 [ Time Frame: Week 6, Week 12, Week 24 ]
  • Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61 [ Time Frame: Weekly from Study Entry to Week 12 (R61) ]
  • Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33 [ Time Frame: Weekly from Study Entry to Week 24 ]

Central Contacts and Locations

Central contacts

Dimitris Kiosses, PhD

914-997-4381dkiosses@med.cornell.edu

Laurie Evans, MS

914-682-9100lad9011@med.cornell.edu

Locations

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

Recruiting

White Plains, New York, United States, 10605

Contacts

Dimitris Kiosses, PhD

914-997-4381dkiosses@med.cornell.edu

Laurie Evans, MS

914-682-9100lad9011@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

Keywords

  • Older Adults
  • Middle Aged Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-10-29.