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

NCT06859060 | Not Yet Recruiting

• 2 other identifiers: 23081594852U54MD007579-39
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Disease; Serious Mental Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Hemoglobin A1c

  baseline,6 and 12 months follow up and 6 and 12 months post intervention

• Lipid Panel

  baseline,6 and 12 months follow up and 6 and 12 months post intervention

• Basic Metabolic Panel

  baseline,6 and 12 months follow up and 6 and 12 months post intervention

• Smoking - Severity Dependence Scale

  baseline,6 and 12 months follow up and 6 and 12 months post intervention

• Physical Activity - International Physical Activity Questionnaire

  baseline,6 and 12 months follow up and 6 and 12 months post intervention

Study Arms (2)

BRIDGES Intervention

EXPERIMENTAL

Participants randomized to the experimental condition will receive the BRIDGES Healthcare Manager Intervention.

Behavioral: BRIDGES Healthcare Manager Intervention

Enhanced Treatment as Usual (ETAU)

OTHER

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)

Interventions

BRIDGES Healthcare Manager Intervention BEHAVIORAL

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.

BRIDGES Intervention

Enhanced Treatment as Usual (ETAU) OTHER

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.

Enhanced Treatment as Usual (ETAU)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (2)

Mayagüez Medical Center Primary Care Psychology Clinic

Mayagüez, Puerto Rico, 00681, Puerto Rico

Location

PHSU Wellness Center

Ponce, Puerto Rico, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Chronic Disease; Social Stigma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Central Study Contacts

Eliut Rivera-Segarra, PhD

CONTACT

787-840-2575; elrivera@psm.edu

Nelmit Tollinchi, PhD

CONTACT

939-905-0420; bridgespr@psm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): February 28, 2029
• Study Completion (Estimated): February 28, 2029
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

PR (2)