- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07388641
Улучшение продуктивной интеграции в сообщество у ветеранов, имевших опыт бездомности (MI-CBT)
Инновационное комбинированное психосоциальное вмешательство для улучшения продуктивной интеграции в сообщество среди ветеранов с опытом бездомности
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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Peter C Hunt, PhD MPH BA
- Номер телефона: 6113 (562) 826-8000
- Электронная почта: Peter.Hunt3@va.gov
Учебное резервное копирование контактов
- Имя: John J Fraser, DPT PhD
- Электронная почта: john.fraser@va.gov
Места учебы
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California
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West Los Angeles, California, Соединенные Штаты, 90073-1003
- Рекрутинг
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Главный следователь:
- Michael F Green, PhD
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Контакт:
- Irma Gvilia, PhD MS
- Номер телефона: 38024 (818) 891-7711
- Электронная почта: Irma.Gvilia@va.gov
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Контакт:
- Linda D Nguyen, BS
- Номер телефона: 48145 (310) 478-3711
- Электронная почта: linda.nguyen@va.gov
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: MI-CBT
Combination of Motivational Interviewing and Cognitive Behavioral Therapy |
Psychosocial intervention to increase motivation for work and productive activities
Другие имена:
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Активный компаратор: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Action subscale of the University of Rhode Island Change Assessment Scale
Временное ограничение: 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)
Временное ограничение: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks
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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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Временное ограничение: 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
|
Соавторы и исследователи
Следователи
- Главный следователь: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RRD4-008-25M
- 1I01RD000643-01A1 (Другой номер гранта/финансирования: Department of Veterans Affairs)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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