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Forbedring af produktiv samfundsintegration for veteraner med hjemløshedserfaring (MI-CBT)

25. september 2026 opdateret af: VA Office of Research and Development

En innovativ kombineret psykosocial intervention til at forbedre produktiv samfundsintegration for hjemløse-veteraner

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

106

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Peter C Hunt, PhD MPH BA
  • Telefonnummer: 6113 (562) 826-8000
  • E-mail: Peter.Hunt3@va.gov

Undersøgelse Kontakt Backup

Studiesteder

    • California
      • West Los Angeles, California, Forenede Stater, 90073-1003
        • Rekruttering
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • Ledende efterforsker:
          • Michael F Green, PhD
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MI-CBT

Combination of Motivational Interviewing and Cognitive Behavioral Therapy

Psychosocial intervention to increase motivation for work and productive activities

Andre navne:
  • MI-CBT
Aktiv komparator: 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.

Andre navne:
  • Sunde Livsstile

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Action subscale of the University of Rhode Island Change Assessment Scale
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. september 2026

Primær færdiggørelse (Anslået)

14. september 2030

Studieafslutning (Anslået)

14. september 2031

Datoer for studieregistrering

Først indsendt

28. januar 2026

Først indsendt, der opfyldte QC-kriterier

28. januar 2026

Først opslået (Faktiske)

5. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • RRD4-008-25M
  • 1I01RD000643-01A1 (Andet bevillings-/finansieringsnummer: Department of Veterans Affairs)

Plan for individuelle deltagerdata (IPD)

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