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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183230
• Other study ID #: 21-12024207
• Secondary ID: 1R61MH128516
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2022
• Est. completion date: September 30, 2026

Study information

• Verified date: December 2023
• Source: Weill Medical College of Cornell University
• Contact: Dimitris Kiosses, PhD
• Phone: 914-997-4381
• Email: dkiosses[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: September 30, 2026
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	New York Presbyterian Hospital/Weill Cornell Medicine	New York	New York
United States	Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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