Pilot Study of a Behavioral Program for Resident Depression in Skilled Nursing Facilities (BRISK-I)
15 de junio de 2026 actualizado por: Evan Plys, Massachusetts General Hospital
Building Resilience in Skilled Nursing Care: Open Pilot for a Behavioral Health Intervention
The goal of this clinical trial is to test a behavioral health program (Interventions for Stressful Transitions in Later Life, InSTILL, for Individuals) for skilled nursing facility residents.
The main questions it aims to answer is whether the program is program is feasible, satisfactory, and helpful.
Participants will join 6 bi-weekly sessions of the InSTILL program.
Participants will complete assessments at three timepoints (all) and a brief-exit interview.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: BRISK Study Coordinator
- Número de teléfono: 617-643-9406
- Correo electrónico: brisk@mgb.org
Ubicaciones de estudio
-
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Reclutamiento
- Massachusetts General Hospital
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Contacto:
- BRISK Study Coordinator
- Número de teléfono: 617-643-9406
- Correo electrónico: brisk@mgb.org
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Psychological distress, as indicated by a score Patient Health Questionnaire- 2 ≥ 2 OR Patient Health Questionnaire-9 ≥ 5
- 5+ chronic conditions based on Elixhauser Comorbidity Index
- Aged ≥ 18 years
- Able and willing to participate in the study
Exclusion Criteria:
- Intended length of SNF stay < 7 days
- More than mild cognitive impairment, as indicted by Brief Interview for Mental Status (BIMS) <13
- Participant's roommate is already enrolled in study/intervention
- High risk of suicide/active documented SI per the PHQ-9, item 9 or otherwise
- Participation in newly initiated psychotherapy
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: InSTILL for Individuals
Participants in this arm will participate in the Interventions for Stressful Transitions in Later Life (InSTILL), a behavioral health intervention tailored to the needs of short stay nursing facility residents.
InSTILL for Individuals includes 6 sessions (2x per week for about 3 weeks) delivered in person or remotely.
|
The Interventions for Stressful Transitions in Later Life (InSTILL) intervention is for skilled nursing facility residents experiencing elevated levels of psychological distress.
The intervention is designed to improve life management skills and emotion regulation skill with the goal of reducing depression symptoms.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Mean Total Score Treatment Credibility
Periodo de tiempo: After session 1 of intervention, an average of 1 week after baseline
|
3-item self-report measure of participant's belief regarding how helpful the intervention will be for them.
Higher scores (min = 0, max = 30) scores indicate greater credibility.
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After session 1 of intervention, an average of 1 week after baseline
|
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Mean Total Score Client Satisfaction Questionnaire
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
|
3-item self-report measure assessing patient satisfaction with the program.
Higher total scores (min = 3, max = 12) indicate greater satisfaction.
|
Post intervention, an average of 4 weeks after baseline
|
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Percentage of Eligible Participants Enrolled
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
|
Percentage of eligible approached individuals that are enrolled into the study.
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Post intervention, an average of 4 weeks after baseline
|
|
Percentage of Participants with Missing Data
Periodo de tiempo: 4 weeks after post-intervention
|
Percentage of all participants with no measure fully missing at 4-week follow-up.
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4 weeks after post-intervention
|
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Attendance Rate
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
|
Percentage of participants completing 4/6 sessions of the intervention.
|
Post intervention, an average of 4 weeks after baseline
|
|
Clinician Fidelity
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
|
Percentage of InSTILL sessions delivered with 100% adherence on a study-specific Fidelity Checklist, based on those randomly sampled to be assessed.
|
Post intervention, an average of 4 weeks after baseline
|
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Number of Adverse Events
Periodo de tiempo: 4 weeks after post-intervention
|
Number of adverse events related to participation in the study.
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4 weeks after post-intervention
|
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Treatment Acceptability Survey
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
|
Percentage of participants scoring above the scale midpoint on all Treatment Acceptability Survey items (developed for the current study).
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Post intervention, an average of 4 weeks after baseline
|
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Percentage of Participants Meeting Participant Comprehension Criterion
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
|
Percentage of participants scoring 7+ on a single-item cognitive load question (min=0, max=10)
|
Post intervention, an average of 4 weeks after baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Health Questionnaire-9
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
9-item self-report measure of depression symptoms.
Higher scores (min=0, max=27) indicate greater depressive symptoms.
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
Selection, Optimization, and Compensation (SOC) in Everyday Use
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
4-item self-report measure of the application of selection, optimization, and compensation strategies in daily life.
Items are averaged for a composite score, with higher scores indicate greater SOC strategy use (Range = 1-6).
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
|
Committed Action Questionnaire
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
8-item self-report measure of pursuit of valued goals despite challenges and difficulties.
Higher scores indicate greater use and effectiveness of emotional regulation skills (Range = 0-48).
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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General Anxiety Disorder-7
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
7-item self-report measure of anxiety symptoms.
Higher scores indicate higher levels of anxiety symptoms (Range = 0-21).
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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Euro QoL-5D 5L
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
6-item self-report measure of subjective health-related quality of life.
Higher scores indicate worse health-related quality of life (Range = 5-25).
The scale also includes a separately scored single-item global health indicator, asked on a 0-100 scale with higher scores indicate higher subjective health-related quality of life.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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COREQ
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline
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4-item self-report of nursing facility satisfaction.
Higher averaged scores indicate greater facility satisfaction (Range = 1-5).
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Post intervention, an average of 4 weeks after baseline
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University of Washington Resilience Scale Short Form
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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4-item self-report of an individual's perceived resilience.
Summed scores will be converted to T-scores using a conversion table.
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Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
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Psychotropic medication use
Periodo de tiempo: Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
|
Chart or self reported psychotropic medication use.
Patients will self-report changes to medication, including dosage, at post-intervention and follow-up
|
Baseline; Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Re-hospitalization
Periodo de tiempo: Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Resident re-hospitalization during the study period
|
Post intervention, an average of 4 weeks after baseline; 4 weeks after post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Evan Plys, PhD, Massachusetts General Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de noviembre de 2025
Finalización primaria (Estimado)
1 de octubre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
9 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2026
Publicado por primera vez (Actual)
17 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024P001945B
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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