Clinical trial NCT05183230: 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
Overall status: RECRUITING
Phase: NA
Conditions: Suicide, Attempted
Suicidal Ideation
Depression
Keywords: Older Adults
Middle Aged Adults
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-01-10
Enrollment: 115
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61
timeFrame: Study Entry, Week 6, Week 12
measure: Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
timeFrame: Study Entry, Week 6, Week 12, Week 24
measure: Change in Self-Reported Affect - R61
timeFrame: Study Entry, Week 6, Week 12
measure: Change in Self-Reported Affect - R33
timeFrame: Study Entry, Week 6, Week 12, Week 24
measure: Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
timeFrame: Study Entry, Week 6, Week 12
measure: Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
timeFrame: Study Entry, Week 6, Week 12, Week 24
measure: Change in Client Satisfaction with Treatment (CSQ) - R61
timeFrame: Week 6, Week 12
measure: Change in Client Satisfaction with Treatment (CSQ) - R33
timeFrame: Week 6, Week 12, Week 24
measure: Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
timeFrame: Weekly from Study Entry to Week 12 (R61)
measure: Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
timeFrame: Weekly from Study Entry to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital/Weill Cornell Medicine
state: New York
city: White Plains
country: United States
facility: Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Dimitris Kiosses, PhD
role: PRINCIPAL_INVESTIGATOR
References: