An observational study in Severe Mental Illness, Hospitalizations Psychiatric and Rural Healthcare-seeking Behaviour, sponsored by Yale University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Yale University · Observational
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.
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.
2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.
This study's planned enrollment of 25 is below the median of 200 across 488 observational studies indexed under Mental Disorders.
Browse Mental Disorders studies →Yale University is the lead sponsor of 1,763 studies on the registry; 292 are open to participants now.
Of its 217 completed or terminated interventional studies of FDA-regulated products, 128 (59%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: Baseline and 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline and 6 months
Plan to share: Yes — DATA WILL BE SHARED WITH THE NATIONAL DATA ARCHIVE (NDA)
Supporting information: Study protocol
Access criteria: VIA THE NDA
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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