Schizophrenia Spectrum DisordersNCT06138054
MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI
A study testing MI-CBTech in people with Schizophrenia Spectrum Disorders and Psychotic Affective Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Spectrum Disorders, Psychotic Affective Disorders, Psychotic Mood Disorders
- What is being tested?
- MI-CBTech
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Mark R McGee, BA, 310-478-3711 ext. 42192, Mark.McGee2@va.gov
Amy M Jimenez, PhD
About this study
Official title: Improving Community Integration in Homeless Veterans With Serious Mental Illness: A Pilot Study of MI-CBT Enhanced With Mobile Technology
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).
Read the 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.
- Conditions
- Schizophrenia Spectrum Disorders, Psychotic Affective Disorders, Psychotic Mood Disorders, Homelessness, Ill-Housed Persons
- Being tested
- MI-CBTech, Mindfulness control
- Keywords
- Community Integration, Telerehabilitation, Telemedicine, Cognitive Behavioral Therapy, Motivational Interviewing, Mobile Applications, Smartphone, Smartphone Apps
- Medical subject headings
- Affective Disorders, Psychotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI-CBTechBehavioural
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 controlBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At study completion, typically 16 weeks after randomization
Secondary outcomes (3)
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%.
Measured: At screening, prior to enrollment
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.
Measured: 8-weeks after end of treatment
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.
Measured: End of 8-week treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Apr 2024
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Amy M Jimenez, PhD, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138054
- Sponsor's protocol ID
- D4633-P
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2023
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified, anonymized dataset of all IPD that underlie results in a publication will be created and shared.
Publications
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.
PubMed 31744429Green 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.
PubMed 32517838Ayano 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.
PubMed 31775786Granholm 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.
PubMed 19628761Wong-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.
PubMed 29504450Fairburn 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.
PubMed 28110672Tsai 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.
PubMed 27075492
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Community Integration in Homeless Veterans With Serious Mental Illness: A Pilot Study of MI-CBT Enhanced With Mobile Technology
- ClinicalTrials.gov ID
- NCT06138054
- Acronym / sponsor ID
- D4633-P
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MI-CBTech | Experimental | Behavioral: MI-CBTechAn 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. |
| Mindfulness control | Active comparator | Behavioral: Mindfulness controlAn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MI-CBTechThree 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. | Behavioural | MI-CBTech |
| Mindfulness controlThree 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. | Behavioural | Mindfulness control |
Primary outcome
Baseline assessment completion rate
Time frame: At baseline, prior to randomization
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.
End of treatment assessment completion rate
Time frame: End of 8-week treatment phase
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.
Remote treatment adherence rate
Time frame: End of 8-week treatment phase
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.
Satisfaction rating index
Time frame: At study completion, typically 16 weeks after randomization
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.
3 secondary outcomes
Screen failure rate
Time frame: At screening, prior to enrollment
Follow-up assessment completion rate
Time frame: 8-weeks after end of treatment
In-person treatment completion rate
Time frame: End of 8-week treatment phase
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Background: PubMed 31744429Young 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.
- Background: PubMed 32517838Green 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.
- Background: PubMed 31775786Ayano 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.
- Background: PubMed 19628761Granholm 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.
- Background: PubMed 29504450Wong-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.
- Background: PubMed 28110672Fairburn 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.
- Background: PubMed 27075492Tsai 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.
- Individual participant dataSharing planned: Yes. A de-identified, anonymized dataset of all IPD that underlie results in a publication will be created and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy M Jimenez, PhD principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI-CBTech in people with Schizophrenia Spectrum Disorders and Psychotic Affective Disorders, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy M Jimenez, PhD ((310) 478-3711, Amy.Jimenez@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline assessment completion rate (time frame: At baseline, prior to randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06138054, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025; AzTrials last refreshed its copy on 31 Oct 2026.