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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
115
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.
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.
New York Presbyterian Hospital/Weill Cornell Medicine
New York, New York, United States
NOT_YET_RECRUITINGWeill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
White Plains, New York, United States
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weekly from Study Entry to Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.