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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: MI-CBTechExperimental treatment 1 intervention
Group B: Mindfulness controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline, prior to randomization
2

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.

Time frame
End of 8-week treatment phase
3

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.

Time frame
End of 8-week treatment phase
4

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.

Time frame
At study completion, typically 16 weeks after randomization

Secondary outcomes

1

Screen failure rate

The investigators will assess feasibility of both MI-CBTech and mindfulness control treatment arms based on recruitment using a screening failure rate (fraction of potential participants who complete the consent process but are deemed ineligible) of no more than 40%.

Time frame
At screening, prior to enrollment
2

Follow-up 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 follow-up assessment.

Time frame
8-weeks after end of treatment
3

In-person treatment completion rate

The investigators will assess tolerability of MI-CBTech based on adherence using a completion rate of at least 80% for the in-person treatment sessions.

Time frame
End of 8-week treatment phase

Other outcomes

Sponsors and contacts

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