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

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Suicide, Attempted; Suicidal Ideation; Depression

Treatments: Behavioral: Optimized WellPATH-PREVENT; Behavioral: WellPATH-PREVENT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05183230

R33MH128516 (U.S. NIH Grant/Contract)

R61MH128516 (U.S. NIH Grant/Contract)

21-12024207

Details and patient eligibility

About

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).

Full 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.

Enrollment: 115 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 3 patient groups

Proof-of-Concept WellPATH-PREVENT (R61)

Experimental group

Treatment:

Behavioral: WellPATH-PREVENT

Optimized WellPATH-PREVENT (R33)

Experimental group

Treatment:

Behavioral: Optimized WellPATH-PREVENT

Attention Control Usual Care (R33)

No Intervention group

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.