Community-Based Intensive Treatment (CBIT): Meeting the Complex Needs of Rural Adults With Serious Mental Illness

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.

Primary outcomes

• Change in Days to Re-hospitalization [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.

Secondary outcomes

• Change in Days to first appointment. [Baseline and 6 months]: 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.
• Change in Number outpatient visits [Baseline and 6 months]: 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.
• Change in Screening for Social Determinants of Health: Housing Stability (SCRN-SDOH) [Baseline and 6 months]: To assess housing instability. Total score range 0-7, higher scores indicating greater housing instability.
• Change in Screening for Social Determinants of Health (SCRN-SDOH): food insecurity [Baseline and 6 months]: To assess food insecurity. Total score range 0-7, higher scores indicating greater food insecurity.
• Change in Number of days employed [Baseline and 6 months]: 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.
• Change in Recovery Markers: Increase sense of recovery [Baseline and 6 months]: 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.
• Change in Experienced Discrimination: Intersectional Discrimination Measure [Baseline and 6 months]: 44-items (with branching logic) assessing discrimination, rating scales vary by question, summary score are represented by means across items
• Change in WHO Quality of Life (WHOQOL) Brief [Baseline and 6 months]: 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.
• Change in Overall Wellness: Increase in overall Wellness (8-Dimensions of Wellness) - Swarbrick et al., 2025 [Baseline and 6 months]: 67-item survey measuring wellness with higher scores indicating higher wellness, rating scale 1-4, summary score meaned across items
• Change in Short Form Survey (SF-12): Physical [Baseline and 6 months]: 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.
• Change in Patient Health Questionnaire-9 (PHQ-9) to assess depression [Baseline and 6 months]: 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.
• Change in Addiction Severity Index: Substance Use [Baseline and 6 months]: 37-item survey measuring addiction. Question format varies with some scores ranging from 0 to 1. Higher values indicate more severe problems.
• Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) [Baseline and 6 months]: To assess functioning and disability. Total score range 0-48 with higher scores indicating more difficulty.
• Change in Access To Health Services (from Phenx Toolkit) [Baseline and 6 months]: 10 questions measuring access to healthcare services, answer format varies (nominal categories, yes/no, various rating scales).
• Change in General Self-Efficacy Scale (GSE) [Baseline and 6 months]: 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.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

• ELIZABETH FLANAGAN, Ph.D., Principal investigator, Yale University
• MARK COSTA, M.D., M.P.H., Principal investigator, Yale University

NIH grants: R61MH144505