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

Last updated: October 27, 2025
Sponsor: Weill Medical College of Cornell University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Suicide

Treatment

Optimized WellPATH-PREVENT

WellPATH-PREVENT

Clinical Study ID

NCT05183230
21-12024207
R33MH128516
R61MH128516
1R61MH128516
  • Ages 50-90
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 50-90 years old

  • Diagnosis (based on a modified SCID-5 Clinical Trials Version to assess DSM-5diagnoses): Any DSM-5 except: current diagnosis of Psychotic Disorder; diagnosis ofDementia

  • Recent hospitalization for suicidal ideation or suicide attempt; at hospitaladmission, Columbia Suicide Severity Rating Scale (CSSR-S) ≥ 2, "Non-specific ActiveSuicidal Thoughts."

  • We will also include patients on psychotropics and on after-care communitypsychotherapy.

Exclusion

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 orkidney failure; major surgery; stroke or myocardial infarction during the threemonths prior to entry

  • Aphasia, sensory problems, and/or inability to speak English.

Study Design

Total Participants: 115
Treatment Group(s): 2
Primary Treatment: Optimized WellPATH-PREVENT
Phase:
Study Start date:
April 22, 2022
Estimated Completion Date:
September 30, 2026

Study Description

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.

Connect with a study center

  • New York Presbyterian Hospital/Weill Cornell Medicine

    New York, New York 10065
    United States

    Site Not Available

  • Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

    White Plains, New York 10605
    United States

    Site Not Available

  • New York Presbyterian Hospital/Weill Cornell Medicine

    New York 5128581, New York 5128638 10065
    United States

    Site Not Available

  • Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

    White Plains 5144336, New York 5128638 10605
    United States

    Active - Recruiting

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