Recruiting

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

ClinicalTrials.gov IDNCT07705776

PhaseNA

Enrollment40

SponsorUniversity of Colorado, Boulder

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Depression and/or Anxiety in the Mild-to-moderate Range, Stress (Psychology), Chronic Medical Illness

About this study

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.

Interventions

Behavioral: SanaMente — SanaMente is a culturally responsive, peer-led behavioral program designed to support mental health and promote healthy lifestyle behaviors among rural Latino/a adults with chronic medical conditions and mental health concerns. The program is delivered by trained bilingual peer mentors in small group sessions over 6-8 weeks and integrates evidence-based strategies to improve depression, anxiety, stress, sleep, physical activity, nutrition, and overall well-being. The intervention emphasizes culturally relevant content, peer support, and skill-building to enhance self-management and emotional wellness.

Primary outcomes

Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) (Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8))
Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) (Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8))
Body Weight (Baseline and Post-Program (week6-8))
Systolic Blood Pressure (Changes from Baseline and Post-Program (week6-8) will be evaluated)
Diastolic Blood Pressure (Changes from Baseline and Post-Program (week6-8) will be evaluated)
Resting Heart Rate (Changes from Baseline and Post-Program (week6-8) will be evaluated)
Glycemic control as assessed by Hemoglobin A1c (HbA1c) (Changes from Baseline and Post-Program (week6-8) will be evaluated)
Total Cholesterol (Changes from baseline to post-program (week 6-8) will be evaluated.)

Eligibility information

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.

Study locations

La Clinica del Pueblo, Carbondale, Colorado 81623 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.