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- Ensaio Clínico NCT07388641
Melhorar a Integração Comunitária Produtiva em Veteranos com Experiência de Sem-Abrigo (MI-CBT)
Uma Intervenção Psicossocial Combinada Inovadora para Melhorar a Integração Produtiva na Comunidade em Veteranos com Experiência de Sem-Abrigo
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Peter C Hunt, PhD MPH BA
- Número de telefone: 6113 (562) 826-8000
- E-mail: Peter.Hunt3@va.gov
Estude backup de contato
- Nome: John J Fraser, DPT PhD
- E-mail: john.fraser@va.gov
Locais de estudo
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California
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West Los Angeles, California, Estados Unidos, 90073-1003
- Recrutamento
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Investigador principal:
- Michael F Green, PhD
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Contato:
- Irma Gvilia, PhD MS
- Número de telefone: 38024 (818) 891-7711
- E-mail: Irma.Gvilia@va.gov
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Contato:
- Linda D Nguyen, BS
- Número de telefone: 48145 (310) 478-3711
- E-mail: linda.nguyen@va.gov
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: MI-CBT
Combination of Motivational Interviewing and Cognitive Behavioral Therapy |
Psychosocial intervention to increase motivation for work and productive activities
Outros nomes:
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Comparador Ativo: 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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Action subscale of the University of Rhode Island Change Assessment Scale
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Prazo: 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
Patrocinador
Investigadores
- Investigador principal: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- RRD4-008-25M
- 1I01RD000643-01A1 (Número de outro subsídio/financiamento: Department of Veterans Affairs)
Plano para dados de participantes individuais (IPD)
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