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

NCT07887113 | Not Yet Recruiting DMC

• 2 other identifiers: 20000427701R61MH144505-01
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Severe Mental Illness; Hospitalizations Psychiatric; Rural Healthcare-seeking Behaviour; Rural Health; Community Based Participatory Research; Care Coordination; Recovery

Keywords

RE-HOSPITALIZATION; RURAL HEALTH; CARE COORDINATION; INTENSIVE OUTPATIENT TREATMEMT; RECOVERY

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 months

Secondary Outcomes (15)

• Change in Days to first appointment.

  Baseline and 6 months

• Change in Number outpatient visits

  Baseline and 6 months

• Change in Screening for Social Determinants of Health: Housing Stability (SCRN-SDOH)

  Baseline and 6 months

• Change in Screening for Social Determinants of Health (SCRN-SDOH): food insecurity

  Baseline and 6 months

• Change in Number of days employed

  Baseline and 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University Program For Recovery and Community Health

New Haven, Connecticut, 06513, United States

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• ELIZABETH FLANAGAN, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• MARK COSTA, M.D., M.P.H.

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELIZABETH FLANAGAN, Ph.D.

CONTACT

203-444-8034; ELIZABETH.FLANAGAN@YALE.EDU

LUZ S OCASIO

CONTACT

203-764-8692; LUZ.OCASIO@YALE.EDU

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: October 4, 2026
• Primary Completion (Estimated): September 7, 2028
• Study Completion (Estimated): September 8, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: VIA THE NDA

Locations

US (1)