WellPATH-PREVENT: una intervención móvil para adultos de mediana edad y mayores hospitalizados por ideación o intento de suicidio
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Dimitris Kiosses, PhD
- Número de teléfono: 914-997-4381
- Correo electrónico: dkiosses@med.cornell.edu
Copia de seguridad de contactos de estudio
- Nombre: Laurie Evans, MS
- Número de teléfono: 1012570 914-682-9100
- Correo electrónico: lad9011@med.cornell.edu
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10065
- Aún no reclutando
- New York Presbyterian Hospital/Weill Cornell Medicine
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Contacto:
- Dimitris Kiosses, PhD
- Número de teléfono: 914-997-4381
- Correo electrónico: dkiosses@med.cornell.edu
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Contacto:
- Laurie Evans, MS
- Número de teléfono: 1012570 914-682-9100
- Correo electrónico: lad9011@med.cornell.edu
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White Plains, New York, Estados Unidos, 10605
- Reclutamiento
- Weill Cornell Institute of Geriatric Psychiatry, Weill Cornell Medicine
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Contacto:
- Dimitris Kiosses, PhD
- Número de teléfono: 914-997-4381
- Correo electrónico: dkiosses@med.cornell.edu
-
Contacto:
- Laurie Evans, MS
- Número de teléfono: 1012570 914-682-9100
- Correo electrónico: lad9011@med.cornell.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Prueba de concepto WellPATH-PREVENT (R61)
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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. |
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Experimental: WellPATH-PREVENT optimizado (R33)
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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. |
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Sin intervención: Attention Control Usual Care (R33)
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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R61
Periodo de tiempo: Study Entry, Week 6, Week 12
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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
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Change in Event Related Potential - Late Positive Potential (ERP/LPP) - R33
Periodo de tiempo: Study Entry, Week 6, Week 12, Week 24
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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
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Change in Self-Reported Affect - R61
Periodo de tiempo: Study Entry, Week 6, Week 12
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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
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Change in Self-Reported Affect - R33
Periodo de tiempo: Study Entry, Week 6, Week 12, Week 24
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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
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Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R61
Periodo de tiempo: Study Entry, Week 6, Week 12
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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
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Change in Emotion Regulation (Cognitive Reappraisal Subscale of ER Questionnaire) - R33
Periodo de tiempo: Study Entry, Week 6, Week 12, Week 24
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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
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Change in Client Satisfaction with Treatment (CSQ) - R61
Periodo de tiempo: Week 6, Week 12
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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
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Change in Client Satisfaction with Treatment (CSQ) - R33
Periodo de tiempo: Week 6, Week 12, Week 24
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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
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Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R61
Periodo de tiempo: Weekly from Study Entry to Week 12 (R61)
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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)
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Change in Suicide Risk - Columbia Suicide Severity Scale (C-SSRS) - R33
Periodo de tiempo: Weekly from Study Entry to Week 24
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dimitris Kiosses, PhD, Weill Medical College of Cornell University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 21-12024207
- R61MH128516 (Subvención/contrato del NIH de EE. UU.)
- R33MH128516 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
De-identified data from this study is submitted to the National Database for Clinical Trials related to Mental Illness (NDCT). The NDCT is run by NIH and allows researchers studying mental health to collect and share information with each other. Researchers must apply to NIH in order to be allowed access to the data for 1 year's time; after which they must re-apply.
Marco de tiempo para compartir IPD
Data will be available as per NIH's data sharing policy.
Criterios de acceso compartido de IPD
Access criteria is determined by NIH and can be requested by applying online.
Información sobre medicamentos y dispositivos, documentos del estudio
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Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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