MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
NCT ID: NCT06138054
Last Updated: 2025-11-10
Study Results
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Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-01
2026-12-31
Brief Summary
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Detailed Description
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Digital technology can provide innovative solutions to these treatment barriers and help close the access gap to meet the needs of previously homeless Veterans with serious mental illness (SMI). Technology-based treatments administered remotely via mobile smartphone applications have proven popular and successful in helping people build psychotherapy skills and manage mental health symptoms in real-world settings. Technology-based interventions can be easily disseminated, increasing access while reducing costs associated with face-to-face clinical care. Among homeless and SMI populations, smartphone use is quite high and research data indicate a willingness to use mobile applications for healthcare, whether in a clinical or research setting.
Cognitive behavioral therapy (CBT) is a structured, time-limited treatment that focuses on changing maladaptive thoughts and problematic behaviors that interfere with functioning. Goals for therapy can focus on improved functioning in several aspects of daily living, including community integration. While CBT shows promise in improving community integration in individuals with SMI experiencing homelessness, individuals may still have low motivation to engage with and adhere to treatment. Studies integrating Motivational Interviewing (MI) with CBT have shown positive results for a variety of disorders, including serious mental illness. MI increases initiation and maintenance of behavioral change. Brief application of MI prior to CBT (MI-CBT) has been shown to enhance treatment engagement and improve outcomes.
Importantly, the efficacy of augmenting individualized MI-CBT with digital tools in a homeless SMI Veteran population has not been evaluated. Therefore, it is not known whether administration of some aspects of an MI-CBT intervention via remote smartphone application might improve engagement and maintain therapeutic gains in this population. This study will test the feasibility and acceptability of an 8-week MI-CBT intervention enhanced with mobile technology (MI-CBTech) to improve community integration in homeless Veterans with SMI. 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).
Participants will be administered interviews (symptom ratings and community functioning), and performance-based assessments of cognitive ability at an in-person baseline visit. Participants will then be randomly assigned to one of two intervention arms: MI-CBTech or a mindfulness control, by recruiters who are blind to condition assignment. Both treatment arms will consist of 8 weeks of active intervention, including three individual in-person sessions occurring over the first 2 week period (3 MI sessions for MI-CBTech and 3 supportive therapy sessions for the control arm) followed by 6 weeks of mobile phone application use. During the period of remote application use, both arms will have phone check-ins during weeks 2, 4, and 6 to obtain information on application use and troubleshoot any potential problems with compliance or completion. Following completion of active treatment, participants will undergo a repeat assessment of symptom ratings and community functioning (8-week end of treatment assessment). Participants will then complete a final evaluation of symptoms ratings and community functioning as well as an exit interview (follow-up assessment 16 weeks after baseline). Total assessment time is 4 hrs for the baseline assessment and 2 hrs for the end of treatment and follow-up assessments. Both the end of treatment and follow-up assessments may be completed in-person or remotely via telephone or videoconference depending on participant preference. The remote portions of both intervention arms will be administered via participant's own smartphones. For otherwise eligible Veterans who do not own a smartphone, iPad, tablet, or other device, the investigators will help them obtain one.
This study has the potential to fill key gaps in treatment options for this high priority population during a critical transition period and will help guide a future large-scale randomized controlled trial utilizing these interventions.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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.
MI-CBTech
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
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.
Mindfulness control
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.
Interventions
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MI-CBTech
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
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.
Eligibility Criteria
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Inclusion Criteria
* age 18-65 years
* diagnosis of non-affective or affective psychotic illness as confirmed by chart review
* history of homelessness
* sufficiently fluent in English to consent, understand procedures, and complete assessments and intervention
* medically and clinically stable (i.e. able to participate in and complete assessments and intervention).
Exclusion Criteria
* history of serious head injury (i.e., loss of consciousness \> 1 hr, neuropsychological sequelae, cognitive rehabilitation post head injury)
* evidence of IQ \< 70 or developmental disability
* moderate or severe substance use disorder in the past month based on chart review
18 Years
65 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Amy M Jimenez, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Locations
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VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Mark R McGee, BA
Role: primary
References
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Young AS, Cohen AN, Niv N, Nowlin-Finch N, Oberman RS, Olmos-Ochoa TT, Goldberg RW, Whelan F. Mobile Phone and Smartphone Use by People With Serious Mental Illness. Psychiatr Serv. 2020 Mar 1;71(3):280-283. doi: 10.1176/appi.ps.201900203. Epub 2019 Nov 20.
Green MF, Wynn JK, Gabrielian S, Hellemann G, Horan WP, Kern RS, Lee J, Marder SR, Sugar CA. Motivational and cognitive factors linked to community integration in homeless veterans: study 1 - individuals with psychotic disorders. Psychol Med. 2022 Jan;52(1):169-177. doi: 10.1017/S0033291720001889. Epub 2020 Jun 10.
Ayano G, Tesfaw G, Shumet S. The prevalence of schizophrenia and other psychotic disorders among homeless people: a systematic review and meta-analysis. BMC Psychiatry. 2019 Nov 27;19(1):370. doi: 10.1186/s12888-019-2361-7.
Granholm E, Ben-Zeev D, Link PC. Social disinterest attitudes and group cognitive-behavioral social skills training for functional disability in schizophrenia. Schizophr Bull. 2009 Sep;35(5):874-83. doi: 10.1093/schbul/sbp072. Epub 2009 Jul 23.
Wong-Anuchit C, Chantamit-O-Pas C, Schneider JK, Mills AC. Motivational Interviewing-Based Compliance/Adherence Therapy Interventions to Improve Psychiatric Symptoms of People With Severe Mental Illness: Meta-Analysis. J Am Psychiatr Nurses Assoc. 2019 Mar/Apr;25(2):122-133. doi: 10.1177/1078390318761790. Epub 2018 Mar 5.
Fairburn CG, Patel V. The impact of digital technology on psychological treatments and their dissemination. Behav Res Ther. 2017 Jan;88:19-25. doi: 10.1016/j.brat.2016.08.012.
Tsai J, Link B, Rosenheck RA, Pietrzak RH. Homelessness among a nationally representative sample of US veterans: prevalence, service utilization, and correlates. Soc Psychiatry Psychiatr Epidemiol. 2016 Jun;51(6):907-16. doi: 10.1007/s00127-016-1210-y. Epub 2016 Apr 13.
Other Identifiers
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D4633-P
Identifier Type: -
Identifier Source: org_study_id