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

Study Overview
=================
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.

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

Conditions
-----------------
Suicide, Attempted, Suicidal Ideation, Depression

Intervention / Treatment
-----------------
* Behavioral: WellPATH-PREVENT
* Behavioral: Optimized WellPATH-PREVENT


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proof-of-Concept WellPATH-PREVENT (R61)<br> | Behavioral: WellPATH-PREVENT<br>* 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.<br>|
| Experimental: Optimized WellPATH-PREVENT (R33)<br> | Behavioral: Optimized WellPATH-PREVENT<br>* 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.<br>|
| No Intervention: Attention Control Usual Care (R33)<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Older Adults, Middle Aged Adults