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Una intervención de clubes de cuentos virtuales de vida para mejorar la soledad y la apatía en los adultos mayores que viven en la comunidad (LSC Feasible)

22 de septiembre de 2026 actualizado por: Montefiore Medical Center

Una intervención de clubes de cuentos de vida virtual para mejorar la soledad y la apatía en los adultos mayores que viven en la comunidad: un estudio de factibilidad de métodos mixtos

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Descripción detallada

The purpose of this study is to explore the feasibility of a LSC© intervention to improve loneliness and apathy in community-dwelling older adults.

This pilot study will be conducted to compare loneliness and apathy in lonely individuals without dementia at baseline who receive a virtual group reminiscence therapy intervention (vGRT). The intervention will be delivered weekly over 12 weeks. Loneliness and apathy will be assessed before and after the intervention as described in the Outcome Measures section of this registration. Feasibility will be assessed using quantitative and qualitative measures including feasibility of screening and enrollment, acceptability, and program satisfaction. Qualitative interviews will be conducted with a subset of 30 individuals to explore acceptability, barriers, and facilitators of the intervention.

This study will provide evidence for the feasibility of a virtual group reminiscence therapy for community dwelling older adults to reduce loneliness and apathy. This approach is both innovative and pragmatic because it will leverage an existing community-based service, with an established infrastructure and track record within the community to deliver the intervention. As such, the proposed research has the potential for broad implications for community-based research and aligns with multiple translational science principles.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

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: Mirnova Ceide, MD
  • Número de teléfono: 347-920-0112
  • Correo electrónico: mceide@montefiore.org

Ubicaciones de estudio

    • New York
      • The Bronx, New York, Estados Unidos, 10467
        • Reclutamiento
        • Montefiore Medical Center
        • Contacto:

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

60 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 60 and over
  • English or Spanish fluency
  • Able to provide informed consent

Exclusion Criteria:

  • Dementia based on Aging and Dementia (AD8) score of ≥4 or previous dementia diagnosis
  • Severe auditory or visual loss
  • Lack of access to internet connection or phone

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: Life Story Club

Virtual Group Reminiscence Therapy

Virtual group reminiscence therapy will be provided by the Life Story Club©. Participants will meet virtually via Zoom© with their group (6-10 people) weekly for one hour over a 12-week period to exchange life stories and share in conversation. Groups will be conducted in entirely in English or Spanish, based on participant preference. Each week, the LSC© facilitator will guide the group with question prompts to encourage participants to share personal information, build friendships & rapport, and create a sense of community. LSC© facilitators are trained in group interview techniques, technology management, and know how to respond appropriately to sensitive information that may emerge during group exchanges.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Loneliness
Periodo de tiempo: From baseline to 3 months and 6 months

Loneliness will be assessed using the University of California, Los Angeles (UCLA) Loneliness Scale questionnaire. The UCLA Loneliness Scale is a 20-item measure that assesses how often a person feels disconnected from others. Participants provide responses using a 4-point Likert scale where 1 = never; 2 = rarely; 3 = sometimes; 4 = always, for an overall possible scoring range of 20-80, such that higher scores are associated with increased loneliness. Positively worded items in the questionnaire must be reverse-coded before reporting. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of an increase in loneliness from baseline and negative values a decrease in loneliness from baseline. Group scores will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months
Change in Apathy
Periodo de tiempo: From baseline to 3 months and 6 months

Apathy will be assessed using the self-reported Apathy Evaluation Scale (AES-S). The AES-S is an 18-item questionnaire that addresses characteristics of goal directed behavior that reflects apathy including behavioral, cognitive, and emotional indicators. Participants provide responses based on a 4-point Likert scale where 1 = not at all true; 2 = slightly true; 3 = somewhat true; and 4 = very true, for an overall possible scoring range of 18-72, such that higher scores are associated with greater apathy. Positively worded items in the scale must be reverse-coded before reporting. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased apathy from baseline and negative values decreased apathy from baseline. Group scores will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in cognition
Periodo de tiempo: From baseline to 3 months and 6 months

Cognition will be assessed using a version of the Telephone-Montreal Cognitive Assessment (T-MoCA). The T-MoCA is a 22-item phone-administered exam which assesses a range of global cognitive domains including attention, memory, language, and orientation. Each item is one point yielding an overall possible scoring range of 0-22, with higher scores being indicative of better cognitive function. Scores of 18 or below are generally suggestive of Mild Cognitive Impairment (MCI). For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased cognition from baseline and negative values decreased cognition from baseline. Group scores will be summarized using basic descriptive statistics. To reduce practice effect Version (V)8.1 will be administered at baseline, V8.2 at 3 months, and V8.3 at 6 months. Scoring ranges are identical for all 3 versions.

From baseline to 3 months and 6 months
Change in Meaning and Purpose
Periodo de tiempo: From baseline to 3 months and 6 months

Meaning and purpose will be assessed as a composite measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose 4-item scale. The 4-item scale is designed to assess an individual's subjective experience of meaning and purpose in life. Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 4-20, such that higher scores are associated with greater meaning and purpose. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased experiences of meaning and purpose from baseline and negative values decreased experiences of meaning and purpose from baseline. Group results will be summarized using basic descriptive statistics

From baseline to 3 months and 6 months
Change in Depressive Symptoms
Periodo de tiempo: From baseline to 3 months and 6 months

Depressive symptoms will be assessed by administration of the Geriatric Depression Scale - Short Form (GDS-15), The GDS-15 is a 15-item questionnaire in which participants provide a dichotomous (Yes/No) response as to how they have felt over the prior week. Answers suggestive of depression are bolded/italicized on the questionnaire (may either be 'Yes' or 'No' depending on the item). A score of 1 point is assigned for each bolded/italicized response such that higher scores are associated with more depressive symptoms. A score of 0 to 5 is normal. A score greater than 5 suggests depression. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increase in depressive symptoms from baseline and negative values a decrease in depressive symptoms from baseline. Results will be summarized using basic descriptive statistics.

From baseline to 3 months and 6 months
Change in Social Support
Periodo de tiempo: From baseline to 3 months and 6 months

Social Support will be assessed using the Medical Outcomes Study (MOS) Social Support Scale. The MOS is a 19-item multidimensional, self-administered instrument that measures the availability of support, if needed. The overall social support component of the MOS Social Support scale will be used. Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 19-95, such that higher scores are associated with greater availability of social support. For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased social support and purpose from baseline and negative values decreased social support from baseline. Group results will be summarized using basic descriptive statistics

From baseline to 3 months and 6 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Mirnova Ceide, MD, Montefiore Medical Center

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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)

15 de agosto de 2025

Finalización primaria (Estimado)

31 de diciembre de 2027

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

26 de marzo de 2025

Primero enviado que cumplió con los criterios de control de calidad

2 de abril de 2025

Publicado por primera vez (Actual)

9 de abril de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025-16787
  • UM1TR004400 (Subvención/contrato del NIH de EE. UU.)
  • 2025 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

Data sharing to be determined.

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

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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