Severe Mental IllnessCBITNCT07887113
Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness
An observational study of Severe Mental Illness and Hospitalizations Psychiatric, run by Yale University at 1 site in United States.
Trial summary
The purpose for this research project is to successfully achieve the primary systems intervention outcome, maintaining fidelity to the intervention model and time to rehospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Mental Illness, Hospitalizations Psychiatric, Rural Healthcare-seeking Behaviour
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2026to 8 Sep 2029
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The target population is adults diagnosed with a serious mental illness living in rural areas and at risk of rehospitalization after being discharged from a psychiatric hospital. Eligible person must be currently receiving services from the County's CBIT offered program.
Who may be able to join
- The target population is adults diagnosed with a serious mental illness living in rural areas and at risk of rehospitalization after being discharged from a psychiatric hospital.
- Currently referred or receiving services from the standing CBIT program offered, age 18 years of age or older, and able to provide consent.
- Eligibility criteria for the CBIT program are aged 18 or older, who have a serious mental illness (e.g., diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder), and who need an intensive level of care.
- In addition, CBIT program participants must meet at least two of the following criteria: 1) At least two psychiatric hospitalizations in the past 12 months or lengths of stay equal to 30 days or more within a 12-month time frame, 2) unmanageable or persistent severe major symptoms (e.g., psychotic symptoms, suicidality) 3) are unhoused, living in unsafe housing, or at risk of becoming unhoused, 4) currently receiving treatment from an inpatient or supervised residential setting, but able to live independently with adequate provision of community-based intensive services. Participants must also live or receive services within the selected rural counties.
Who cannot join
- Adults not diagnosed with a serious mental illness, not at risk of rehospitalization
- Not having be hospitalized
- Not currently receiving or referred for CBIT services
- Not able to provide informed consent
- Not being 18 years of age or older
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
Yale University Program For Recovery and Community Health
New Haven, Connecticut, 06513
LUZ S OCASIO, 203-764-8692, LUZ.OCASIO@YALE.EDU
KIMBERLY D BLACKMAN, MSW, 203-444-4819, KIMBERLY.BLACKMAN@YALE.EDU
About this study
Official title: Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness Post-Psychiatric Hospitalization
The purpose for this research project is to successfully achieve the primary systems intervention outcome, maintaining fidelity to the intervention model and time to rehospitalization. In the proposed research, the plan is to build the research infrastructure to ultimately test the effectiveness of CBIT on time to rehospitalization in a sample of rural Americans with SMI and determine the effective implementation strategies to bring the program to scale to address the significant unmet needs of this population. The proposed research will improve scientific knowledge and clinical and community practice by identifying the CBIT intervention's key components associated with enhancements in overall wellness and the mechanisms through which these improvements are attained. This may also better inform the practical and logistical design of future research for CBIT.
Read the detailed description
The research design will begin with Phase I as follows:
Utilizing the Community Based Participatory Research (CBPR) process will inform the development of the research alongside the Community Advisory Board (CAB) members as co-researchers. The CAB members will serve as co-investigators and will offer guidance and support for the systems intervention needed to implement CBIT. At the project start, the CAB will define CBIT intervention components, advise on MOUs with implementation sites, and refine provider training. The CAB will also assess feasibility, acceptability, safety, and tolerability. The CAB meetings will be held monthly for years one and two. The research will utilize the RE-AIM framework; the CAB will evaluate the CBIT intervention, protocol manual, and fidelity measure. Standard survey items will be used to discuss key questions with the CAB, ensuring fidelity measure includes system-level factors.
Participants will be asked to complete pre and post the CBIT intervention interviews. The research will also conduct qualitative interviews with the participants who participated in the quantitative portion of the research. Data analysis and evaluation will inform next steps for Phase II (R33). Three benchmarks are established during Phase I that will shape next steps procedures: refined training material via the CBPR process alongside with the CAB, MOU's for the new counties, and virtual co-learning collaboratives for trainings. Aim II will set agreements, procedures, and training for CBIT implementation. A working group will include key personnel from the target counties, representatives from Magellan, local mental health authorities from Cambria and Blair Counties, and Nulton Diagnostic and Treatment Center personnel. Virtual co-learning collaboratives will train providers and stakeholders, fostering enhanced sharing, creativity, and trust. Service providers and county administrators will share their perspectives and challenges, be trained on CBIT intervention, and help refine the contextual and systemic factors for successful implementation. Co-learning collaboratives will be conducted virtually. The pilot will test these aspects rigorously with qualitative interviews also covering participants' experience with CBIT. The research will engage with Magellan Health to access medical claims for participants who consent to participate in the pilot, using claims data to calculate rehospitalization time and service utilization in Phase I. Participants will sign a release of information for the CBIT research team to receive identified data about their service use, diagnosis, and demographic information. This release of information will be signed after participant has provided consent into the study.
The results of this Phase I, (R61) study will be used to inform a future Phase II (R33 phase) study.
- Conditions
- Severe Mental Illness, Hospitalizations Psychiatric, Rural Healthcare-seeking Behaviour, Rural Health, Community Based Participatory Research, Care Coordination
- Keywords
- RE-HOSPITALIZATION, RURAL HEALTH, CARE COORDINATION, INTENSIVE OUTPATIENT TREATMEMT, RECOVERY
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community-Based Intensive Treatment (CBIT) | The target population for this research study is persons 18 years of age or older diagnosed with serious mental health challenges who live in a rural setting with uncoordinated health care, as well as poverty and societal discrimination against people with mental illness. This target population also has poor Social Determinants of Health (SDoH), such as housing, food, transportation, employment, and social support difficulties. This population must also be receiving CBIT services offered by the county. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Days to Re-hospitalization
Days in the community from discharge to re-hospitalization. Data will be gathered from administrative dataset and service use measure. Higher scores mean more days in the community. Range is 0 to 182.
Measured: Baseline and 6 months
Secondary outcomes (15)
Change in Days to first appointment.
Days to first appointment from discharge, number of appointments. Data will be gathered from administrative data set and service use measure. Higher scores mean more days until first appointment. Range is 0 to 182.
Measured: Baseline and 6 months
Change in Number outpatient visits
Number of outpatient visits. Data will be gathered from administrative data set and service use measure. Higher scores mean more days until first appointment. Range is 0 to 364.
Measured: Baseline and 6 months
Change in Screening for Social Determinants of Health: Housing Stability (SCRN-SDOH)
To assess housing instability. Total score range 0-7, higher scores indicating greater housing instability.
Measured: Baseline and 6 months
Change in Screening for Social Determinants of Health (SCRN-SDOH): food insecurity
To assess food insecurity. Total score range 0-7, higher scores indicating greater food insecurity.
Measured: Baseline and 6 months
Change in Number of days employed
Number of days employed. Data will be gathered from Quality-of-Life Scale (Endicott, 1993). Higher scores mean more days employed. Range is 0 to 180.
Measured: Baseline and 6 months
Change in Recovery Markers: Increase sense of recovery
The Recovery Markers Questionnaire was developed to provide the mental health field with a multifaceted measure that collects information on personal recovery. The RMQ includes 24 Likert Scale items regarding the recovery process and intermediate outcomes. Mean scores are used for total scores and range from 1-5. Higher scores indicate more recovery.
Measured: Baseline and 6 months
Change in Experienced Discrimination: Intersectional Discrimination Measure
44-items (with branching logic) assessing discrimination, rating scales vary by question, summary score are represented by means across items
Measured: Baseline and 6 months
Change in WHO Quality of Life (WHOQOL) Brief
26-item self-report questionnaire developed by the World Health Organization to assess an individual's perceived quality of life. Total score range 0 to 100 with higher scores indicating a higher perceived quality of life.
Measured: Baseline and 6 months
Change in Overall Wellness: Increase in overall Wellness (8-Dimensions of Wellness) - Swarbrick et al., 2025
67-item survey measuring wellness with higher scores indicating higher wellness, rating scale 1-4, summary score meaned across items
Measured: Baseline and 6 months
Change in Short Form Survey (SF-12): Physical
A short, general health questionnaire used to measure functional health and well-being from a patient's point of view. Higher scores mean better reported health. Question format and rating scale varies.
Measured: Baseline and 6 months
Change in Patient Health Questionnaire-9 (PHQ-9) to assess depression
Nine items asking about the frequency of specific depressive symptoms experienced over the past two weeks. rating scale is 0-3 (primarily); summary score is meaned across items, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline and 6 months
Change in Addiction Severity Index: Substance Use
37-item survey measuring addiction. Question format varies with some scores ranging from 0 to 1. Higher values indicate more severe problems.
Measured: Baseline and 6 months
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
To assess functioning and disability. Total score range 0-48 with higher scores indicating more difficulty.
Measured: Baseline and 6 months
Change in Access To Health Services (from Phenx Toolkit)
10 questions measuring access to healthcare services, answer format varies (nominal categories, yes/no, various rating scales).
Measured: Baseline and 6 months
Change in General Self-Efficacy Scale (GSE)
10-item self-report questionnaire to assess a person's belief in their ability to handle difficult demands and cope with stress. Total score range. Total score range 10 to 40 points with higher scores indicating stronger self-efficacy and better confidence in overcoming obstacles.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start4 Oct 2026 (estimated)
- Primary completion7 Sep 2028 (estimated)
- Study completion8 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- ELIZABETH FLANAGAN, Ph.D., Principal investigator, Yale UniversityMARK COSTA, M.D., M.P.H., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887113
- Sponsor's protocol ID
- 2000042770
- Other IDs
- 1R61MH144505-01
- Acronym
- CBIT
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: DATA WILL BE SHARED WITH THE NATIONAL DATA ARCHIVE (NDA)
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness Post-Psychiatric Hospitalization
- ClinicalTrials.gov ID
- NCT07887113
- Acronym / sponsor ID
- CBIT / 2000042770
- Conditions
- Severe Mental Illness, Hospitalizations Psychiatric, Rural Healthcare-seeking Behaviour, Rural Health, Community Based Participatory Research, Care Coordination
- Keywords
- RE-HOSPITALIZATION, RURAL HEALTH, CARE COORDINATION, INTENSIVE OUTPATIENT TREATMEMT, RECOVERY
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Oct 2026 (estimated)
- Primary completion
- 7 Sep 2028 (estimated)
- Study completion
- 8 Sep 2029 (estimated)
- First posted
- 21 Oct 2026 (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.
The purpose for this research project is to successfully achieve the primary systems intervention outcome, maintaining fidelity to the intervention model and time to rehospitalization. In the proposed research, the plan is to build the research infrastructure to ultimately test the effectiveness of CBIT on time to rehospitalization in a sample of rural Americans with SMI and determine the effective implementation strategies to bring the program to scale to address the significant unmet needs of this population. The proposed research will improve scientific knowledge and clinical and community practice by identifying the CBIT intervention's key components associated with enhancements in overall wellness and the mechanisms through which these improvements are attained. This may also better inform the practical and logistical design of future research for CBIT.
Detailed description
The research design will begin with Phase I as follows:
Utilizing the Community Based Participatory Research (CBPR) process will inform the development of the research alongside the Community Advisory Board (CAB) members as co-researchers. The CAB members will serve as co-investigators and will offer guidance and support for the systems intervention needed to implement CBIT. At the project start, the CAB will define CBIT intervention components, advise on MOUs with implementation sites, and refine provider training. The CAB will also assess feasibility, acceptability, safety, and tolerability. The CAB meetings will be held monthly for years one and two. The research will utilize the RE-AIM framework; the CAB will evaluate the CBIT intervention, protocol manual, and fidelity measure. Standard survey items will be used to discuss key questions with the CAB, ensuring fidelity measure includes system-level factors.
Participants will be asked to complete pre and post the CBIT intervention interviews. The research will also conduct qualitative interviews with the participants who participated in the quantitative portion of the research. Data analysis and evaluation will inform next steps for Phase II (R33). Three benchmarks are established during Phase I that will shape next steps procedures: refined training material via the CBPR process alongside with the CAB, MOU's for the new counties, and virtual co-learning collaboratives for trainings. Aim II will set agreements, procedures, and training for CBIT implementation. A working group will include key personnel from the target counties, representatives from Magellan, local mental health authorities from Cambria and Blair Counties, and Nulton Diagnostic and Treatment Center personnel. Virtual co-learning collaboratives will train providers and stakeholders, fostering enhanced sharing, creativity, and trust. Service providers and county administrators will share their perspectives and challenges, be trained on CBIT intervention, and help refine the contextual and systemic factors for successful implementation. Co-learning collaboratives will be conducted virtually. The pilot will test these aspects rigorously with qualitative interviews also covering participants' experience with CBIT. The research will engage with Magellan Health to access medical claims for participants who consent to participate in the pilot, using claims data to calculate rehospitalization time and service utilization in Phase I. Participants will sign a release of information for the CBIT research team to receive identified data about their service use, diagnosis, and demographic information. This release of information will be signed after participant has provided consent into the study.
The results of this Phase I, (R61) study will be used to inform a future Phase II (R33 phase) study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-Based Intensive Treatment (CBIT) | – | –The target population for this research study is persons 18 years of age or older diagnosed with serious mental health challenges who live in a rural setting with uncoordinated health care, as well as poverty and societal discrimination against people with mental illness. This target population also has poor Social Determinants of Health (SDoH), such as housing, food, transportation, employment, and social support difficulties. This population must also be receiving CBIT services offered by the county. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population is adults diagnosed with a serious mental illness living in rural areas and at risk of rehospitalization after being discharged from a psychiatric hospital. Eligible person must be currently receiving services from the County's CBIT offered program.
Key inclusion criteria (4 listed)
- The target population is adults diagnosed with a serious mental illness living in rural areas and at risk of rehospitalization after being discharged from a psychiatric hospital.
- Currently referred or receiving services from the standing CBIT program offered, age 18 years of age or older, and able to provide consent.
- Eligibility criteria for the CBIT program are aged 18 or older, who have a serious mental illness (e.g., diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder), and who need an intensive level of care.
- In addition, CBIT program participants must meet at least two of the following criteria: 1) At least two psychiatric hospitalizations in the past 12 months or lengths of stay equal to 30 days or more within a 12-month time frame, 2) unmanageable or persistent severe major symptoms (e.g., psychotic symptoms, suicidality) 3) are unhoused, living in unsafe housing, or at risk of becoming unhoused, 4) currently receiving treatment from an inpatient or supervised residential setting, but able to live independently with adequate provision of community-based intensive services. Participants must also live or receive services within the selected rural counties.
Key exclusion criteria (5 listed)
- Adults not diagnosed with a serious mental illness, not at risk of rehospitalization
- Not having be hospitalized
- Not currently receiving or referred for CBIT services
- Not able to provide informed consent
- Not being 18 years of age or older
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Days to Re-hospitalization
Time frame: Baseline and 6 months
Days in the community from discharge to re-hospitalization. Data will be gathered from administrative dataset and service use measure. Higher scores mean more days in the community. Range is 0 to 182.
15 secondary outcomes
Change in Days to first appointment.
Time frame: Baseline and 6 months
Change in Number outpatient visits
Time frame: Baseline and 6 months
Change in Screening for Social Determinants of Health: Housing Stability (SCRN-SDOH)
Time frame: Baseline and 6 months
Change in Screening for Social Determinants of Health (SCRN-SDOH): food insecurity
Time frame: Baseline and 6 months
Change in Number of days employed
Time frame: Baseline and 6 months
Change in Recovery Markers: Increase sense of recovery
Time frame: Baseline and 6 months
Change in Experienced Discrimination: Intersectional Discrimination Measure
Time frame: Baseline and 6 months
Change in WHO Quality of Life (WHOQOL) Brief
Time frame: Baseline and 6 months
Change in Overall Wellness: Increase in overall Wellness (8-Dimensions of Wellness) - Swarbrick et al., 2025
Time frame: Baseline and 6 months
Change in Short Form Survey (SF-12): Physical
Time frame: Baseline and 6 months
Change in Patient Health Questionnaire-9 (PHQ-9) to assess depression
Time frame: Baseline and 6 months
Change in Addiction Severity Index: Substance Use
Time frame: Baseline and 6 months
Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Baseline and 6 months
Change in Access To Health Services (from Phenx Toolkit)
Time frame: Baseline and 6 months
Change in General Self-Efficacy Scale (GSE)
Time frame: Baseline and 6 months
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 21 Oct 2026.
- Individual participant dataSharing planned: Yes. DATA WILL BE SHARED WITH THE NATIONAL DATA ARCHIVE (NDA)
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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.
ELIZABETH FLANAGAN, Ph.D. principal investigator
Yale University
MARK COSTA, M.D., M.P.H. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Illness and Hospitalizations Psychiatric, run by Yale University 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 21 Oct 2026. 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 ELIZABETH FLANAGAN, Ph.D. (203-444-8034, ELIZABETH.FLANAGAN@YALE.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Days to Re-hospitalization (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.