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

NCT05183230 | Recruiting DMC

• 3 other identifiers: 21-12024207R61MH128516R33MH128516
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 2

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

Keywords

Older Adults; Middle Aged Adults

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Weekly from Study Entry to Week 24

Study Arms (3)

Proof-of-Concept WellPATH-PREVENT (R61)

EXPERIMENTAL

Behavioral: WellPATH-PREVENT

Optimized WellPATH-PREVENT (R33)

EXPERIMENTAL

Behavioral: Optimized WellPATH-PREVENT

Attention Control Usual Care (R33)

NO INTERVENTION

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 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.

Proof-of-Concept WellPATH-PREVENT (R61)

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.

Optimized WellPATH-PREVENT (R33)

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

New York Presbyterian Hospital/Weill Cornell Medicine

New York, New York, 10065, United States

NOT YET RECRUITING

Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine

White Plains, New York, 10605, United States

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Dimitris Kiosses, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitris Kiosses, PhD

CONTACT

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

Laurie Evans, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistants administering the assessments will be blind to participant randomization in the R33 phase.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (2)