RecruitingNot Applicable

SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino/a Communities

United States40 participantsStarted 2026-03-06

Plain-language summary

The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effectiveness of the SanaMente peer-led mental health and lifestyle program for rural Latino/a adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are: * Is the SanaMente program feasible and acceptable for rural Latino/a adults with chronic medical conditions and mental health concerns? * Does participation in the SanaMente program improve mental health outcomes (depression, anxiety, and stress), healthy lifestyle behaviors (sleep, physical activity, and nutrition), and overall well-being? This is a single-arm pilot study without comparison group. Participants will: * Participate in the 6-8 week SanaMente peer-led group program. * Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction. * Complete an exit survey and have the option to participate in a focus group to provide feedback on the program's usability, acceptability, perceived impact, and suggestions for improvement.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 18 years or older. * Identify as Hispanic/Latino/a. * Patients of La Clínica del Pueblo in Carbondale, Colorado. * Spanish-speaking (bilingual Spanish-English speakers are eligible). * Interest in improving your physical and emotional well-being. * Are currently managing or are at risk for chronic medical or metabolic conditions (e.g., diabetes, cardiovascular disease, liver, or kidney conditions), but a diagnosis is not required. * Experiencing or at risk for stress, low mood, or anxiety (formal diagnosis not required) * Willingness and ability to participate in the SanaMente program. * Willing to provide a release of information authorizing study staff to communicate with La Clínica del Pueblo in the event that a participant endorses suicidality or if it becomes necessary to share relevant medical information to ensure participant safety and appropriate care. Exclusion Criteria: * Individuals who are unable to provide informed consent. * Individuals who are unwilling or unable to participate in the group-based or one-to-one SanaMente sessions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

Timeframe: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)

Timeframe: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

Body Weight

Timeframe: Baseline and Post-Program (week6-8)

Systolic Blood Pressure

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Diastolic Blood Pressure

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Resting Heart Rate

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Glycemic control as assessed by Hemoglobin A1c (HbA1c)

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Trial details

NCT IDNCT07705776

SponsorUniversity of Colorado, Boulder

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Antonella Onofrietti Magrassi, PhD

15417807253 antonella.onofrietti@colorado.edu

View on ClinicalTrials.gov More Depression and/or Anxiety in the Mild-to-moderate Range trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

Timeframe: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)

Timeframe: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

Body Weight

Timeframe: Baseline and Post-Program (week6-8)

Systolic Blood Pressure

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Diastolic Blood Pressure

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Resting Heart Rate

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated

Glycemic control as assessed by Hemoglobin A1c (HbA1c)

Timeframe: Changes from Baseline and Post-Program (week6-8) will be evaluated