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Not yet recruiting NCT07388641

Improving Productive Community Integration in Homeless-experienced Veterans

No phase Interventional Homeless Persons

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Motivational Interviewing and Cognitive Behavioral Therapy, Healthy Behavior Training.
Who it may be relevant to
Registry conditions: Homeless Persons. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Motivational Interviewing and Cognitive Behavioral Therapy
    Psychosocial intervention to increase motivation for work and productive activities
  • Other Healthy Behavior Training
    An educational program on nutrition, exercise, and stress management.

Primary outcome measures

  • 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]
  • Service Use and Resource Form (SURF) [Time frame: baseline, midpoint at 12 weeks, post-treatment at 24 weeks, and follow-up at 36 weeks]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA — West Los Angeles

Identifiers

NCT: NCT07388641 · RRD4-008-25M · 1I01RD000643-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗