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

NCT ID: NCT06859060

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-02-28

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.

Conditions

Chronic Disease; Serious Mental Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

BRIDGES Intervention

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

Group Type: EXPERIMENTAL

BRIDGES Healthcare Manager Intervention

Intervention Type: 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.

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.

Group Type: OTHER

Enhanced Treatment as Usual (ETAU)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Ponce Medical School Foundation, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mayagüez Medical Center Primary Care Psychology Clinic

Mayagüez, Puerto Rico, Puerto Rico

PHSU Wellness Center

Ponce, Puerto Rico, Puerto Rico

Countries

Puerto Rico

Central Contacts

Eliut Rivera-Segarra, PhD

Role: CONTACT

elrivera@psm.edu

787-840-2575

Nelmit Tollinchi, PhD

Role: CONTACT

bridgespr@psm.edu

939-905-0420

Facility Contacts

Nelmit Tollinchi, PhD

Role: primary

bridgespr@psm.edu

939-905-0420

Nelmit Tollinchi, PhD

Role: primary

bridgespr@psm.edu

939-905-0420

Other Identifiers

2U54MD007579-39

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2308159485

Identifier Type: -

Identifier Source: org_study_id