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.
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.
John J Fraser, DPT PhD contact
United States1 site, 1 recruiting
- 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
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.
- Conditions
- Homeless Persons
- 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 group | Role | What they receive |
|---|---|---|
| MI-CBT | Experimental | Combination of Motivational Interviewing and Cognitive Behavioral Therapy Receives: Other: Motivational Interviewing and Cognitive Behavioral Therapy |
| Health Lifestyles | Active comparator | An 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.
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
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)
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.
- First posted5 Feb 2026
- Study start14 Sep 2026
- Primary completion14 Sep 2030 (estimated)
- Study completion14 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Homeless PersonsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Michael F Green, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Combined Psychosocial Intervention to Improve Productive Community Integration in Homeless-experienced Veterans
- ClinicalTrials.gov ID
- NCT07388641
- Acronym / sponsor ID
- MI-CBT / RRD4-008-25M
- Conditions
- Homeless Persons
- Keywords
- motivation, motivational interviewing, psychosocial intervention, work, community integration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 14 Sep 2030 (estimated)
- Study completion
- 14 Sep 2031 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Random assignment to experimental psychosocial treatment of active control.
| Arm | Type | Receives |
|---|---|---|
| MI-CBT | Experimental | Other: Motivational Interviewing and Cognitive Behavioral TherapyCombination of Motivational Interviewing and Cognitive Behavioral Therapy |
| Health Lifestyles | Active comparator | Other: Healthy Behavior TrainingAn educational program that instructs participants on important concepts in nutrition, exercise, and stress management. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral TherapyAlso: MI-CBTPsychosocial intervention to increase motivation for work and productive activities | Other | MI-CBT |
| Healthy Behavior TrainingAlso: Healthy LifestylesAn educational program on nutrition, exercise, and stress management. | Other | Health Lifestyles |
Primary outcome
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
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.
Service Use and Resource Form (SURF)
Time frame: 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
1 secondary outcome
Measure of willingness to exert effort on a cognitive task (Deck choice task)
Time frame: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John J Fraser, DPT PhD contact
Michael F Green, PhD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
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.