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Homeless PersonsMI-CBTNCT07388641

Improving Productive Community Integration in Homeless-experienced Veterans

A study testing Motivational Interviewing and Cognitive Behavioral Therapy and Healthy Behavior Training in people with Homeless Persons, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Homeless Persons
What is being tested?
Motivational Interviewing and Cognitive Behavioral Therapy and Healthy Behavior Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteUnited States
Study dates
14 Sep 2026to 14 Sep 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peter C Hunt, PhD MPH BA contact

(562) 826-8000 ext. 6113

Peter.Hunt3@va.gov

John J Fraser, DPT PhD contact

john.fraser@va.gov

United States1 site, 1 recruiting
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    West Los Angeles, California, 90073-1003

    Irma Gvilia, PhD MS, (818) 891-7711 ext. 38024, Irma.Gvilia@va.gov

    Linda D Nguyen, BS, (310) 478-3711 ext. 48145, linda.nguyen@va.gov

    Recruiting

Other trials in United States

About this study

Official title: An Innovative Combined Psychosocial Intervention to Improve Productive Community Integration in Homeless-experienced Veterans

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.

Read the detailed description

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.

Being tested
Motivational Interviewing and Cognitive Behavioral Therapy, Healthy Behavior Training
Keywords
motivation, motivational interviewing, psychosocial intervention, work, community integration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational Interviewing and Cognitive Behavioral TherapyOther

    Also called MI-CBT

    Psychosocial intervention to increase motivation for work and productive activities

  • Healthy Behavior TrainingOther

    Also called Healthy Lifestyles

    An educational program on nutrition, exercise, and stress management.

Study groups in NCT07388641
Study groupRoleWhat they receive
MI-CBTExperimentalCombination of Motivational Interviewing and Cognitive Behavioral Therapy
Receives: Other: Motivational Interviewing and Cognitive Behavioral Therapy
Health LifestylesActive comparatorAn educational program that instructs participants on important concepts in nutrition, exercise, and stress management.
Receives: Other: Healthy Behavior Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Action subscale of the University of Rhode Island Change Assessment Scale

    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.

    Measured: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

  2. Service Use and Resource Form (SURF)

    Average number of hours of productive activities per week for past month

    Measured: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Secondary outcomes (1)
  1. Measure of willingness to exert effort on a cognitive task (Deck choice task)

    Measure of effort allocation on a cognitive choice task. The range is 0-18 with higher scores indicated more accuracy and effort allocation.

    Measured: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start14 Sep 2026
  3. Primary completion14 Sep 2030 (estimated)
  4. Study completion14 Sep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random assignment to experimental psychosocial treatment of active control.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388641
Sponsor's protocol ID
RRD4-008-25M
Other IDs
1I01RD000643-01A1
Acronym
MI-CBT
Status last verified
Sep 2026
First submitted
28 Jan 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Motivational Interviewing and Cognitive Behavioral Therapy and Healthy Behavior Training in people with Homeless Persons, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter C Hunt, PhD MPH BA ((562) 826-8000 ext. 6113, Peter.Hunt3@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Action subscale of the University of Rhode Island Change Assessment Scale (time frame: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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