- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388641
Improving Productive Community Integration in Homeless-experienced Veterans (MI-CBT)
An Innovative Combined Psychosocial Intervention to Improve Productive Community Integration in Homeless-experienced Veterans
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter C Hunt, PhD MPH BA
- Phone Number: 6113 (562) 826-8000
- Email: Peter.Hunt3@va.gov
Study Contact Backup
- Name: John J Fraser, DPT PhD
- Email: john.fraser@va.gov
Study Locations
-
-
California
-
West Los Angeles, California, United States, 90073-1003
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
Principal Investigator:
- Michael F Green, PhD
-
Contact:
- Irma Gvilia, PhD MS
- Phone Number: 38024 (818) 891-7711
- Email: Irma.Gvilia@va.gov
-
Contact:
- Linda D Nguyen, BS
- Phone Number: 48145 (310) 478-3711
- Email: linda.nguyen@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veteran
- fluent in English
- history of homelessness and currently housed through VA 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: MI-CBT
Combination of Motivational Interviewing and Cognitive Behavioral Therapy
|
Psychosocial intervention to increase motivation for work and productive activities
Other Names:
|
|
Active Comparator: 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks
|
|
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.
|
baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
measure of effort allocation on a cognitive choice task
|
baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Michael F Green, PhD, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RRD4-008-25M
- 1I01RD000643-01A1 (Other Grant/Funding Number: Department of Veterans Affairs)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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