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NCT Number: NCT05183230

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

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).

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Key information

Conditions

Suicide, Attempted Behavior Behavioral Symptoms Depression Self-Injurious Behavior Suicidal Ideation Suicide

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York Presbyterian Hospital/Weill Cornell Medicine, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WellPATH-PREVENT

Behavioral

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

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dimitris Kiosses, PhD

CONTACT

[email protected]

914-997-4381

Laurie Evans, MS

CONTACT

[email protected]

914-682-9100 ext. 1012570

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2022
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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