Clinical trial NCT06138054: MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
Official title: Improving Community Integration in Homeless Veterans With Serious Mental Illness: A Pilot Study of MI-CBT Enhanced With Mobile Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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).

Detailed description: For Veterans experiencing homelessness, permanent housing is only the first step in achieving stability and improved quality of life. Even after attaining permanent housing, many Veterans continue to struggle with many aspects of functioning and day-to-day living. In addition, as Veterans move from temporary to permanent housing, they are at risk of falling out of mental healthcare and other VA services. One of the reasons this transition is so challenging is that in-person interventions, while well-suited for residential treatment programs, are less suitable for Veterans as they leave the VA campus and acquire housing at widely distributed locations. However, few behavioral treatments designed to improve daily functioning, including community integration, have been applied and tested during this transitional period. Whether this kind of treatment could be effective in improving engagement and increasing continuity of care for these Veterans is not known. Furthermore, remote interventions can overcome the disadvantages associated with long distance transportation challenges for therapy appointments and scheduling difficulties.

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Baseline assessment completion rate
timeFrame: At baseline, prior to randomization
measure: End of treatment assessment completion rate
timeFrame: End of 8-week treatment phase
measure: Remote treatment adherence rate
timeFrame: End of 8-week treatment phase
measure: Satisfaction rating index
timeFrame: At study completion, typically 16 weeks after randomization
Secondary outcomes:
measure: Screen failure rate
timeFrame: At screening, prior to enrollment
measure: Follow-up assessment completion rate
timeFrame: 8-weeks after end of treatment
measure: In-person treatment completion rate
timeFrame: End of 8-week treatment phase
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Amy M Jimenez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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