- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07388641
Miglioramento dell'Integrazione Produttiva nella Comunità per Veterani con Esperienze di Senzatetto (MI-CBT)
Un intervento psicosociale combinato innovativo per migliorare l'integrazione produttiva nella comunità dei veterani con esperienza di senzatetto
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Peter C Hunt, PhD MPH BA
- Numero di telefono: 6113 (562) 826-8000
- Email: Peter.Hunt3@va.gov
Backup dei contatti dello studio
- Nome: John J Fraser, DPT PhD
- Email: john.fraser@va.gov
Luoghi di studio
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California
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West Los Angeles, California, Stati Uniti, 90073-1003
- Reclutamento
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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Investigatore principale:
- Michael F Green, PhD
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Contatto:
- Irma Gvilia, PhD MS
- Numero di telefono: 38024 (818) 891-7711
- Email: Irma.Gvilia@va.gov
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Contatto:
- Linda D Nguyen, BS
- Numero di telefono: 48145 (310) 478-3711
- Email: linda.nguyen@va.gov
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: MI-CBT
Combination of Motivational Interviewing and Cognitive Behavioral Therapy |
Psychosocial intervention to increase motivation for work and productive activities
Altri nomi:
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Comparatore attivo: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Action subscale of the University of Rhode Island Change Assessment Scale
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Lasso di tempo: 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
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- RRD4-008-25M
- 1I01RD000643-01A1 (Altro numero di sovvenzione/finanziamento: Department of Veterans Affairs)
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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