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Att förbättra produktiv samhällsintegration för hemlöshetsdrabbade veteraner (MI-CBT)

25 september 2026 uppdaterad av: VA Office of Research and Development

En innovativ kombinerad psykosocial intervention för att förbättra produktiv samhällsintegration hos veteraner med erfarenhet av hemlöshet

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

106

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studera Kontakt Backup

Studieorter

    • California
      • West Los Angeles, California, Förenta staterna, 90073-1003
        • Rekrytering
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • Huvudutredare:
          • Michael F Green, PhD
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MI-CBT

Combination of Motivational Interviewing and Cognitive Behavioral Therapy

Psychosocial intervention to increase motivation for work and productive activities

Andra namn:
  • 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.

Andra namn:
  • Hälsosamma Livsstilar

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Action subscale of the University of Rhode Island Change Assessment Scale
Tidsram: 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)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 september 2026

Primärt slutförande (Beräknad)

14 september 2030

Avslutad studie (Beräknad)

14 september 2031

Studieregistreringsdatum

Först inskickad

28 januari 2026

Först inskickad som uppfyllde QC-kriterierna

28 januari 2026

Första postat (Faktisk)

5 februari 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

30 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

25 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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