MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI

Part of paid clinical trials in West Los Angeles, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06138054
Status
Recruiting
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Conditions

  • Homelessness
  • Ill-Housed Persons
  • Psychotic Affective Disorders
  • Psychotic Mood Disorders
  • Schizophrenia Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MI-CBTech — BEHAVIORAL
    Three in-person MI sessions focused on identifying goals for community integration (in the areas of vocational, recreational, social, or independent living activities) and unhelpful thinking that tends to get in the way of those goals, building motivation for goals, introducing participants to the CBT model and its potential benefits, and downloading and orienting them to the mobile phone application. Six weeks of mobile phone application use to guide participants through CBT. Weekly content will be provided to learn and practice CBT skills to address unhelpful thinking and problem solving to address obstacles to goal attainment. There will be brief content pages worksheets to guide participants through practice. The worksheets will be tailored to each participant, framing the skills around their pre-identified goals and unhelpful thinking patterns. The application will also include access to crisis resources.
  • Mindfulness control — BEHAVIORAL
    Three in-person supportive therapy sessions focused on empathic listening during client-led discussions of presenting concerns, introducing participants to mindfulness (defined as noticing and paying attention to the present moment without judgment), and downloading and orienting them to the mobile phone application. Participants will be informed of potential benefits of mindfulness, including stress reduction and increased self-awareness. Six weeks of mindfulness training mobile application use to help participants learn to practice mindfulness through a gradual, self-guided training program. The application offers a library of information about mindfulness, 12 different audio-guided mindfulness exercises, goal-setting and tracking, customizable reminders, and access to crisis resources.

Study Details

This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone (together called MI-CBTech). The goal of the intervention is to improve community integration in Veterans with serious mental illness (SMI) who have experienced homelessness. A time- and format-matched control arm will include remote mindfulness training. 50 Veterans with SMI experiencing homelessness will be randomized to one of the two arms (25 per arm).

Key Dates

Start date
Apr 1, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: MI-CBTech
    An 8-week experimental intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT). The format of the intervention will be a combination of in-person sessions and remote elements (together called MI-CBTech) delivered via mobile phone or other smart device.
  • Active Comparator: Mindfulness control
    An 8-week active control intervention that combines supportive therapy and mindfulness training. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone or other smart device.

Primary Outcome Measure

Baseline assessment completion rate [ Time Frame: At baseline, prior to randomization ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los AngelesCalifornia90073-1003
Mark R McGee, BA
[email protected]
310-478-3711
Amy M Jimenez, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA· West Los Angeles, CA

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