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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Disease; Serious Mental Illness
• Intervention / Treatment: Behavioral: BRIDGES Healthcare Manager Intervention; Other: Enhanced Treatment as Usual (ETAU)

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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eliut Rivera-Segarra, PhD; Phone Number: 787-840-2575; Email: elrivera@psm.edu
• Study Contact Backup: Name: Nelmit Tollinchi, PhD; Phone Number: 939-905-0420; Email: bridgespr@psm.edu

Study Locations

• Puerto Rico
  • Puerto Rico
    • Mayagüez, Puerto Rico, Puerto Rico, 00681
      • Recruiting
      • Mayagüez Medical Center Primary Care Psychology Clinic
      • Principal Investigator: Eliut Rivera-Segarra, PhD
      • Contact: Nelmit Tollinchi, PhD; Phone Number: 939-905-0420; Email: bridgespr@psm.edu
    • Ponce, Puerto Rico, Puerto Rico, 00716
      • Recruiting
      • PHSU Wellness Center
      • Principal Investigator: Eliut Rivera-Segarra, PhD
      • Contact: Nelmit Tollinchi, PhD; Phone Number: 939-905-0420; Email: bridgespr@psm.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BRIDGES Intervention; Participants randomized to the experimental condition will receive the BRIDGES Healthcare Manager Intervention.	Behavioral: BRIDGES 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.
Other: Enhanced Treatment as Usual (ETAU); Participants randomized to the control condition will receive standard psychiatric care with an informational brochure on accessing primary care providers.	Other: Enhanced Treatment as Usual (ETAU); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recipt of Preventive Primary Care	29-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.	baseline,6 and 12 months follow up and 6 and 12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin A1c	The A1C test is a simple common blood test used to measure blood sugar levels over the past 3 months.	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Lipid Panel	The 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.	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Basic Metabolic Panel	It 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.	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Smoking - Severity Dependence Scale	Five-item scale, used to assess severity of smoking.	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Physical Activity - International Physical Activity Questionnaire	This is a 7-item measure widely used to examine 4 types of physical activity: 1) vigorous, 2) moderate, 3) walking and 4) sitting.	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Health Literacy - Test of Functional Health Literacy for Adults	Questionnaire with 12 items measuring adult functional health literacy in the health care setting.	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Self-Stigma - Self-Stigma of Mental Illness Scale	This 40-item measure examines self stigma's four dimensions (awareness, agreement, self-application and self esteem).	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Provider Stigma - The Mental Health Stigma Scale for Health Professionals	12-item measure examining provider stigma dimensions (social distance, negative character attributions and self-sufficiency).	baseline,6 and 12 months follow up and 6 and 12 months post intervention
Patient-Provider Relationship - Patient Assessment of Chronic Illness Care	20-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.	baseline,6 and 12 months follow up and 6 and 12 months post intervention

Collaborators and Investigators

• Sponsor: Ponce Medical School Foundation, Inc.
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 5, 2025

Study Record Updates

• Last Update Posted (Actual): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Stigma; Wellness; Bridges; Preventive Primary Care; Healthcare Managers
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Social Behavior; Chronic Disease; Social Stigma
• Other Study ID Numbers: 2308159485; 2U54MD007579-39 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No