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

NCT06138054 | Recruiting

• 1 other identifier: D4633-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

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

Keywords

Community Integration; Telerehabilitation; Telemedicine; Cognitive Behavioral Therapy; Motivational Interviewing; Mobile Applications; Smartphone; Smartphone Apps

Outcome Measures

Primary Outcomes (4)

• Baseline assessment completion rate

  The investigators will assess feasibility of both MI-CBTech and mindfulness control treatment arms based on recruitment using a completion rate of at least 80% for the baseline in-person assessment.

  At baseline, prior to randomization

• End of treatment assessment completion rate

  The investigators will assess feasibility of both MI-CBTech and mindfulness control treatment arms based on retention. Specifically, at least 70% of randomized participants will complete the end of treatment assessment.

  End of 8-week treatment phase

• Remote treatment adherence rate

  The investigators will assess tolerability of MI-CBTech based on adherence. Specifically, over 80% of participants will complete at least 70% of application use for a minimum of one hour per week and homework assignments.

  End of 8-week treatment phase

• Satisfaction rating index

  The investigators will assess acceptability of MI-CBTech based on subjective satisfaction. Specifically, at least 75% will report average participant ratings (on a scale of 1 to 10) of a minimum of 7.5 on the composite satisfaction index obtained during exit interview.

  At study completion, typically 16 weeks after randomization

Secondary Outcomes (3)

• Screen failure rate

  At screening, prior to enrollment

• Follow-up assessment completion rate

  8-weeks after end of treatment

• In-person treatment completion rate

  End of 8-week treatment phase

Study Arms (2)

MI-CBTech

EXPERIMENTAL

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.

Behavioral: MI-CBTech

Mindfulness control

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness control

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.

MI-CBTech

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.

Mindfulness control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans currently residing at the VA Greater Los Angeles Mental Health Residential Rehabilitation Treatment Program (Domiciliary)
• 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).

You may not qualify if:

• history of clinically significant neurological disorder determined by medical history (e.g., epilepsy)
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073-1003, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 31744429 BACKGROUND

• 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.

  PMID: 32517838 BACKGROUND

• 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.

  PMID: 31775786 BACKGROUND

• 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.

  PMID: 19628761 BACKGROUND

• 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.

  PMID: 29504450 BACKGROUND

• 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.

  PMID: 28110672 BACKGROUND

• 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.

  PMID: 27075492 BACKGROUND

MeSH Terms

Conditions

Affective Disorders, Psychotic

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Amy M Jimenez, PhD

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy M Jimenez, PhD

CONTACT

(310) 478-3711; Amy.Jimenez@va.gov

Michael F Green, PhD

CONTACT

(310) 268-3376; Michael.Green6@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized by recruiters who are blind to condition assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned using block randomization (sequence pairs of MI-CBTech and mindfulness control in random order) to assign participants 1:1 to the two treatment conditions to ensure the treatment arms remain balanced across the course of the study.

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Data sharing requests will be reviewed by the Investigators.

Locations

US (1)