Chronic DiseaseBRIDGESNCT06859060
Improving Health and Wellness for People With Serious Mental Illness in Puerto Rico
A study testing BRIDGES Healthcare Manager Intervention and Enhanced Treatment as Usual (ETAU) in people with Chronic Disease and Serious Mental Illness, run by Ponce Medical School Foundation, Inc. at 2 sites in Puerto Rico.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Disease, Serious Mental Illness
- What is being tested?
- BRIDGES Healthcare Manager Intervention and Enhanced Treatment as Usual (ETAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesPuerto Rico
- Study dates
- 1 Sep 2025to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Puerto Rico2 sites, 2 recruiting
- Recruiting
Mayagüez Medical Center Primary Care Psychology Clinic
Mayagüez, Puerto Rico, 00681
Nelmit Tollinchi, PhD, 939-905-0420, bridgespr@psm.edu
Eliut Rivera-Segarra, PhD
- Recruiting
PHSU Wellness Center
Ponce, Puerto Rico, 00716
Nelmit Tollinchi, PhD, 939-905-0420, bridgespr@psm.edu
Eliut Rivera-Segarra, PhD
About this study
Official title: 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.
Read the 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
- Being tested
- BRIDGES Healthcare Manager Intervention, Enhanced Treatment as Usual (ETAU)
- Keywords
- Bridges, Stigma, Preventive Primary Care, Healthcare Managers, Wellness
- Medical subject headings
- Chronic Disease, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRIDGES Healthcare Manager InterventionBehavioural
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)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.
| Study group | Role | What they receive |
|---|---|---|
| BRIDGES Intervention | Experimental | Participants randomized to the experimental condition will receive the BRIDGES Healthcare Manager Intervention. Receives: 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. Receives: Other: Enhanced Treatment as Usual (ETAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Secondary outcomes (9)
Hemoglobin A1c
The A1C test is a simple common blood test used to measure blood sugar levels over the past 3 months.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Sep 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ponce Medical School Foundation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859060
- Sponsor's protocol ID
- 2308159485
- Other IDs
- 2U54MD007579-39
- Acronym
- BRIDGES
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Bridges to Better Health and Wellness for People Living With Serious Mental Illness in Puerto Rico
- ClinicalTrials.gov ID
- NCT06859060
- Acronym / sponsor ID
- BRIDGES / 2308159485
- Conditions
- Chronic Disease, Serious Mental Illness
- Keywords
- Bridges, Stigma, Preventive Primary Care, Healthcare Managers, Wellness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ponce Medical School Foundation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRIDGES Intervention | Experimental | Behavioral: BRIDGES Healthcare Manager InterventionParticipants randomized to the experimental condition will receive the BRIDGES Healthcare Manager Intervention. |
| Enhanced Treatment as Usual (ETAU) | Other | 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRIDGES Healthcare Manager InterventionA 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. | Behavioural | BRIDGES Intervention |
| 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. | Other | Enhanced Treatment as Usual (ETAU) |
Primary outcome
Recipt of Preventive Primary Care
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
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.
9 secondary outcomes
Hemoglobin A1c
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Lipid Panel
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Basic Metabolic Panel
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Smoking - Severity Dependence Scale
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Physical Activity - International Physical Activity Questionnaire
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Health Literacy - Test of Functional Health Literacy for Adults
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Self-Stigma - Self-Stigma of Mental Illness Scale
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Provider Stigma - The Mental Health Stigma Scale for Health Professionals
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Patient-Provider Relationship - Patient Assessment of Chronic Illness Care
Time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BRIDGES Healthcare Manager Intervention and Enhanced Treatment as Usual (ETAU) in people with Chronic Disease and Serious Mental Illness, run by Ponce Medical School Foundation, Inc. at 2 sites in Puerto Rico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliut Rivera-Segarra, PhD (787-840-2575, elrivera@psm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recipt of Preventive Primary Care (time frame: baseline,6 and 12 months follow up and 6 and 12 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.