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Mejorando la Integración Comunitaria Productiva en Veteranos con Experiencia de Sinhogarismo (MI-CBT)

25 de septiembre de 2026 actualizado por: VA Office of Research and Development

Una Intervención Psicosocial Combinada Innovadora para Mejorar la Integración Comunitaria Productiva en Veteranos con Experiencia de Sinhogarismo

The VA has been focused on reducing the number of homeless Veterans nationally. However, it has been very difficult to increase the level of productive activities--including work, school, and training--for homeless-experienced Veterans (HEVs), even when the VA provides substantial case management and support services in addition to housing. The overarching aim of this proposed treatment project is to validate an innovative psychosocial intervention (a combination of Motivational Interviewing and Cognitive Behavioral Therapy; MI-CBT) that is designed to enhance motivation and increase productive community integration in Veterans who have experienced homelessness. The efficacy of this new intervention will be evaluated in a randomized control trial that includes 24 weeks of active treatment, and a follow up assessment, compared with a control condition. The results of the proposed study will have clinical and functional impact for Veterans by helping HEVs to achieve fuller community integration.

Descripción general del estudio

Descripción detallada

Significance to the VA: The VA has been heavily focused on reducing the number of homeless Veterans nationally. However, it has been very difficult to increase the level of productive activities--including work, school, and training--for homeless-experienced Veterans (HEVs), even when the VA provides substantial case management and support services in addition to housing. The overarching aim of this proposed project is to validate a recovery-oriented psychosocial intervention that is designed to reduce motivational impairments and increase productive community integration in Veterans who have experienced homelessness and are now housed.

Innovation and Impact: The work in two randomized controlled trials (RCT) has shown that an innovative psychosocial intervention, Motivational Interviewing combined with Cognitive Behavioral Therapy (MI-CBT), significantly increases motivation to achieve personally-relevant functional goals compared with a control procedure. However, the investigators do not know whether this new psychosocial intervention can specifically improve productive aspects of community integration which tend to be most resistant to change. Further, the investigators do not understand the mechanisms through which treatments achieve their benefits. The results of the proposed study will have substantial clinical and functional impact for Veterans by helping HEVs to achieve fuller community integration. The findings will also have the potential to influence the types of psychosocial interventions that are being used in Homeless Programs throughout the VA.

Specific Aims: The proposed project has two aims. Aim 1 is to examine the effects of MI-CBT versus a Healthy Lifestyles control intervention on two primary measures (a proximal outcome of motivation and more distal outcome of behavior) related to productive community integration in HEVs over the 24 weeks of active treatment (i.e., 12 weeks of weekly treatment and 12 weeks of monthly boosters). Aim 2 is to examine the treatment effects of MI-CBT versus the control intervention on a secondary outcome measure of effort allocation. The project has Exploratory Aims to assess whether effort allocation is a mediator of observed changes in motivation and productive behavior and to evaluate whether baseline length of housing is a moderator of the treatment effects.

Methodology: The aims will be evaluated in an RCT that includes 24 weeks of active treatment (group sessions weekly for the first half and boosters every 4 weeks thereafter). A follow up assessment will be conducted at 36 weeks to assess durability. The study will include a total of 106 HEVs who are not involved in jobs, school, or training at their baseline assessment. Participants will be randomly assigned 1:1 to MI-CBT or to an active control condition. There will be two primary outcome measures: the proximal treatment target will be motivation for productive activities; the distal target will be community integration based on average hours of productive activity per week. A secondary outcome will be a measure of effort allocation based on performance on an effort-based decision-making task.

Path to Translation / Implementation: In the proposed RCT, HEVs will be randomly assigned to an innovative psychosocial intervention to improve their productive community activities. It is an efficacy study and is considered a T2-A: Phase II trial which is intended to determine the efficacy of therapy in patients. If the proposed project is successful, the subsequent study would be a larger, multi-site RCT in a broader sample of HEVs. That would move the aims into T2-B: Phase III larger clinical trials to establish efficacy and optimal use in humans.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

106

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: Peter C Hunt, PhD MPH BA
  • Número de teléfono: 6113 (562) 826-8000
  • Correo electrónico: Peter.Hunt3@va.gov

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

    • California
      • West Los Angeles, California, Estados Unidos, 90073-1003
        • Reclutamiento
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • Investigador principal:
          • Michael F Green, PhD
        • Contacto:
          • Irma Gvilia, PhD MS
          • Número de teléfono: 38024 (818) 891-7711
          • Correo electrónico: Irma.Gvilia@va.gov
        • Contacto:
          • Linda D Nguyen, BS
          • Número de teléfono: 48145 (310) 478-3711
          • Correo electrónico: linda.nguyen@va.gov

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

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Veteran
  • fluent in English
  • history of homelessness and currently housed through VA Housing and Urban Development-VA Supportive Housing (HUD-VASH) housing programs
  • expressed willingness to work on a school, work, or training goals

Exclusion Criteria:

  • no clinically significant medical, neurological, or physical condition that would interfere with providing informed consent or valid assessments
  • no visible sign of intoxication on the laboratory assessment visits

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: MI-CBT

Combination of Motivational Interviewing and Cognitive Behavioral Therapy

Psychosocial intervention to increase motivation for work and productive activities

Otros nombres:
  • MI-CBT
Comparador activo: Health Lifestyles

An educational program that instructs participants on important concepts in nutrition, exercise, and stress management.

An educational program on nutrition, exercise, and stress management.

Otros nombres:
  • Estilos de Vida Saludables

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Action subscale of the University of Rhode Island Change Assessment Scale
Periodo de tiempo: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Measure of attitudes and activities related to motivation for productive activities. The range is 8-40 in which higher scores indicate more willingness to change.

baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks
Service Use and Resource Form (SURF)
Periodo de tiempo: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Average number of hours of productive activities per week for past month

baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Periodo de tiempo: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Measure of effort allocation on a cognitive choice task. The range is 0-18 with higher scores indicated more accuracy and effort allocation.

baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

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)

14 de septiembre de 2026

Finalización primaria (Estimado)

14 de septiembre de 2030

Finalización del estudio (Estimado)

14 de septiembre de 2031

Fechas de registro del estudio

Enviado por primera vez

28 de enero de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de enero de 2026

Publicado por primera vez (Actual)

5 de febrero de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de septiembre de 2026

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

25 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

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

producto fabricado y exportado desde los EE. UU.

No

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