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

Primary Purpose

Suicide, Attempted, Suicidal Ideation, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WellPATH-PREVENT
Optimized WellPATH-PREVENT
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring Older Adults, Middle Aged Adults

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • New York Presbyterian Hospital/Weill Cornell Medicine
  • Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Proof-of-Concept WellPATH-PREVENT (R61)

Optimized WellPATH-PREVENT (R33)

Attention Control Usual Care (R33)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 20, 2021
Last Updated
January 14, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05183230
Brief Title
WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt
Official Title
WellPATH-PREVENT: A Mobile Intervention for Middle-Aged and Older Adults Hospitalized for Suicidal Ideation or Attempt
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
September 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicidal Ideation, Depression
Keywords
Older Adults, Middle Aged Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The research assistants administering the assessments will be blind to participant randomization in the R33 phase.
Allocation
Randomized
Enrollment
115 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proof-of-Concept WellPATH-PREVENT (R61)
Arm Type
Experimental
Arm Title
Optimized WellPATH-PREVENT (R33)
Arm Type
Experimental
Arm Title
Attention Control Usual Care (R33)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WellPATH-PREVENT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Optimized WellPATH-PREVENT
Intervention Description
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 Information:
Title
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61
Description
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Time Frame
Study Entry, Week 6, Week 12
Title
Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
Description
ERP is used to measure the amplitude (magnitude) of electrocortical activity (measured in μV) during an emotion regulation task.
Time Frame
Study Entry, Week 6, Week 12, Week 24
Title
Change in Self-Reported Affect - R61
Description
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.
Time Frame
Study Entry, Week 6, Week 12
Title
Change in Self-Reported Affect - R33
Description
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.
Time Frame
Study Entry, Week 6, Week 12, Week 24
Title
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
Description
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.
Time Frame
Study Entry, Week 6, Week 12
Title
Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
Description
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.
Time Frame
Study Entry, Week 6, Week 12, Week 24
Title
Change in Client Satisfaction with Treatment (CSQ) - R61
Description
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.
Time Frame
Week 6, Week 12
Title
Change in Client Satisfaction with Treatment (CSQ) - R33
Description
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.
Time Frame
Week 6, Week 12, Week 24
Title
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
Description
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Time Frame
Weekly from Study Entry to Week 12 (R61)
Title
Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
Description
C-SSRS is used to measure intensity of suicidal ideation. Scores range from 0-5, where higher scores indicate more severe ideation.
Time Frame
Weekly from Study Entry to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dimitris Kiosses, PhD
Phone
914-997-4381
Email
dkiosses@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Laurie Evans, MS
Phone
914-682-9100
Ext
1012570
Email
lad9011@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Kiosses, PhD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian Hospital/Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitris Kiosses, PhD
Phone
914-997-4381
Email
dkiosses@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Laurie Evans, MS
Phone
914-682-9100
Ext
1012570
Email
lad9011@med.cornell.edu
Facility Name
Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dimitris Kiosses, PhD
Phone
914-997-4381
Email
dkiosses@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Laurie Evans, MS
Phone
914-682-9100
Ext
1012570
Email
lad9011@med.cornell.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
IPD Sharing Time Frame
Data will be available as per NIH's data sharing policy.
IPD Sharing Access Criteria
Access criteria is determined by NIH and can be requested by applying online.
IPD Sharing URL
http://nda.nih.gov/

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

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