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Improving Health and Wellness for People With Serious Mental Illness in Puerto Rico

Testing Bridges to Better Health and Wellness for People Living With Serious Mental Illness in Puerto Rico

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06859060
Acronym
BRIDGES
Enrollment
300
Registered
2025-03-05
Start date
2025-09-01
Completion date
2029-02-28
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Disease, Serious Mental Illness

Keywords

Bridges, Stigma, Preventive Primary Care, Healthcare Managers, Wellness

Brief summary

This study evaluates the effectiveness of a culturally tailored intervention, Bridges to Better Health and Wellness (BRIDGES), aimed at reducing chronic disease disparities among Puerto Ricans with serious mental illness (SMI). Participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.

Detailed description

BRIDGES is a multi-level Healthcare Manager Intervention (HMI) that addresses both patient and provider barriers to healthcare. It includes culturally adapted modules to reduce stigma and promote chronic disease prevention. The study uses a hybrid type 1 effectiveness-implementation randomised controlled trial to test its impact on primary care service use, chronic disease outcomes and stigma reduction over 12 months.

Interventions

BEHAVIORALBRIDGES Healthcare Manager Intervention

A culturally adapted, multilevel intervention consisting of monthly 60-minute sessions over a 12-month period. Sessions will be conducted by graduate clinical psychology students acting as healthcare managers. The intervention focuses on care coordination, patient activation, and reducing provider stigma to improve access to preventive primary care services.

Participants will continue to receive standard psychiatric care, including routine visits with their mental health providers at the designated clinical sites. They will also receive a booklet with information on how best to link with primary care providers. This ensures that participants are aware of available resources and basic health care recommendations, but does not include any active follow-up or intervention components.

Sponsors

Ponce Medical School Foundation, Inc.
Lead SponsorINDUSTRY
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults receiving psychiatric or psychological services at the Wellness Center or the Mayaguez Medical Center - Primary Care Diagnosed with at least one serious mental illness SMI (e.g., schizophrenia, bipolar disorder, major depression, etc.) Have at least one risk factor or a diagnosis of a chronic health condition (e.g., diabetes, overweight, hypertension, etc.). Be willing to receive or continue preventive medical care with a primary care physician.

Exclusion criteria

Have started psychiatric or mental health services at least one month before Have been diagnosed with a general mental health condition (e.g., Depression or Anxiety).

Design outcomes

Primary

MeasureTime frameDescription
Recipt of Preventive Primary Carebaseline,6 and 12 months follow up and 6 and 12 months post intervention29-item questionnaire developed by team members. It uses preventive primary care indicators from the US Preventive Service Task Force Guidelines extracted from medical records and examines the use of physical health services over the past 6-months.Indicators are grouped into six categories: physical examinations, screenings for women, screenings for men, laboratory tests, vaccinations, and education. An aggregate preventive primary score is calculated representing the proportion of services for which each participant was eligible depending on age and gender.

Secondary

MeasureTime frameDescription
Self-Stigma - Self-Stigma of Mental Illness Scalebaseline,6 and 12 months follow up and 6 and 12 months post interventionThis 40-item measure examines self stigma's four dimensions (awareness, agreement, self-application and self esteem).
Provider Stigma - The Mental Health Stigma Scale for Health Professionalsbaseline,6 and 12 months follow up and 6 and 12 months post intervention12-item measure examining provider stigma dimensions (social distance, negative character attributions and self-sufficiency).
Patient-Provider Relationship - Patient Assessment of Chronic Illness Carebaseline,6 and 12 months follow up and 6 and 12 months post intervention20-item scale used to assess participants' perspectives on the quality and patient-centeredness of chronic illness care received during the past 6 months from their primary care provider.
Hemoglobin A1cbaseline,6 and 12 months follow up and 6 and 12 months post interventionThe A1C test is a simple common blood test used to measure blood sugar levels over the past 3 months.
Lipid Panelbaseline,6 and 12 months follow up and 6 and 12 months post interventionThe Lipid panel is a simple common blood test used to examine cardiovascular health by analyzing cholesterol in the blood. This test examines four types of lipids in the blood, namely: 1) Total cholesterol, 2 Low-density lipoprotein (LDL), 3) High-density lipoprotein (HDL), and 4) Triglycerides.
Basic Metabolic Panelbaseline,6 and 12 months follow up and 6 and 12 months post interventionIt is a simple common blood group of tests used to examine different naturally occurring chemicals in the blood. The tests can give information heart, kidneys, and liver function. It includes Blood urine nitrogen (BUN), carbon dioxide (C02), Creatinine, Glucose, Serum chloride, Serum potassium, Serum sodium, and Serum Calcium.
Smoking - Severity Dependence Scalebaseline,6 and 12 months follow up and 6 and 12 months post interventionFive-item scale, used to assess severity of smoking.
Health Literacy - Test of Functional Health Literacy for Adultsbaseline,6 and 12 months follow up and 6 and 12 months post interventionQuestionnaire with 12 items measuring adult functional health literacy in the health care setting.
Physical Activity - International Physical Activity Questionnairebaseline,6 and 12 months follow up and 6 and 12 months post interventionThis is a 7-item measure widely used to examine 4 types of physical activity: 1) vigorous, 2) moderate, 3) walking and 4) sitting.

Countries

Puerto Rico

Contacts

CONTACTEliut Rivera-Segarra, PhD
elrivera@psm.edu787-840-2575
CONTACTNelmit Tollinchi, PhD
bridgespr@psm.edu939-905-0420

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026