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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorWeill Medical College of Cornell University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

115 Participants
are divided into 3 treatment groups
Group A: Proof-of-Concept WellPATH-PREVENT (R61)Experimental treatment 1 intervention
Group B: Optimized WellPATH-PREVENT (R33)Experimental treatment 1 intervention
Group C: Attention Control Usual Care (R33)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Study Entry, Week 6, Week 12
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weill Medical College of Cornell University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator