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

NCT07705776 | Recruiting

• 2 other identifiers: 25-05572025*1053
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

rural; Peer-led intervention; Chronic disease; Latino/a mental health

Outcome Measures

Primary Outcomes (19)

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

  Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure of depressive symptom severity. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. Change in total score from baseline to post-program will be evaluated.

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

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

  Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item self-report measure of anxiety symptom severity. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms. Change in total score from baseline to post-program will be evaluated.

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

• Body Weight

  Body weight will be measured in kilograms (kg) using a calibrated digital scale following standardized clinical procedures. Change in body weight from baseline to post-program will be evaluated.

  Baseline and Post-Program (week6-8)

• Systolic Blood Pressure

  Systolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures. Change from baseline to post-program will be evaluated.

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

• Diastolic Blood Pressure

  Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.

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

• Resting Heart Rate

  Resting heart rate will be measured in beats per minute (bpm) using standardized clinical procedures.

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

• Glycemic control as assessed by Hemoglobin A1c (HbA1c)

  HbA1c will be measured from a blood sample as an indicator of average blood glucose over the previous 2-3 months. Values are reported as percentage (%).

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

• Total Cholesterol

  Fasting total cholesterol will be measured in mg/dL.

  Changes from baseline to post-program (week 6-8) will be evaluated.

• LDL Cholesterol

  Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg/dL.

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

• HDL Cholesterol

  Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.

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

• Triglycerides

  Fasting triglycerides will be measured in mg/dL.

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

• Alanine aminotransferase (ALT)

  Alanine aminotransferase (ALT) will be assessed in fasting blood samples and reported in U/L. ALT is a marker of hepatocellular injury.

  Changes from baseline to post-program (week 6-8) will be evaluated.

• Electrolytes

  Electrolyte balance will be assessed using serum sodium (mEq/L), potassium (mEq/L), and chloride (mEq/L), obtained from fasting blood samples. These measures reflect systemic fluid and electrolyte homeostasis.

  Changes from baseline to post-program (week 6-8) will be evaluated.

• Metabolic Function

  Metabolic function will be assessed using fasting plasma glucose (mg/dL), obtained from fasting blood samples as an indicator of glycemic status..

  Changes from baseline to post-program (week 6-8) will be evaluated.

• Aspartate aminotransferase (AST)

  Aspartate aminotransferase (AST) will be assessed in fasting blood samples and reported in U/L. AST is a marker of hepatocellular injury.

  Changes from Baseline to Post-program (week 6-8) will be evaluated

• Total bilirubin

  Total bilirubin will be assessed in fasting blood samples and reported in mg/dL. Total bilirubin is a marker of hepatic excretory function.

  Changes from Baseline to post-program (week 6-8) will be evaluated

• Serum albumin

  Serum albumin will be assessed in fasting blood samples and reported in g/dL. Serum albumin is a marker of hepatic synthetic function and nutritional status.

  Changes from Baseline to post-program (week 6-8) will be evaluated

• Serum creatinine

  Serum creatinine will be assessed in fasting blood samples and reported in mg/dL. Serum creatinine is a marker of glomerular filtration and renal function.

  Changes from Baseline to post-program (week 6-8) will be evaluated

• Blood urea nitrogen (BUN)

  Blood urea nitrogen (BUN) will be assessed in fasting blood samples and reported in mg/dL. BUN is a marker of renal function and protein metabolism.

  Changes from Baseline to post-program (weeks 6-8) will be evaluated

Secondary Outcomes (6)

• Perceived stress as assessed by the Perceived Stress Scale (PSS-10)

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

• Behavioral activation as assessed by the Behavioral Activation for Depression Scale-Short Form (BADS-SF)

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

• Disability and functioning as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

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

• Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)

  Baseline, mid program (week 3-4), post-program (week 6-8)

• Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)

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

Other Outcomes (7)

• Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)

  Post-program (weeks 6-8)

• Program usability and acceptability

  Post-program (week 6-8)

• Participant demographic Characteristics

  baseline

Study Arms (1)

SanaMente Program

EXPERIMENTAL

This is a single-arm, open-label study in which all participants receive the SanaMente intervention. Participants will be enrolled into peer-led groups of approximately 6-10 individuals and will complete the 6-8 week program.

Behavioral: SanaMente

Interventions

SanaMente BEHAVIORAL

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.

SanaMente Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• La Clinica del Pueblo: collaborator

Study Sites (1)

La Clinica del Pueblo

Carbondale, Colorado, 81623, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Anahi Collado, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonella Onofrietti Magrassi, PhD

CONTACT

15417807253; antonella.onofrietti@colorado.edu

Anahi Collado, PhD

CONTACT

3052835243; anahi.collado@colorado.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: This is a single-arm, open-label feasibility and pilot study in which all participants receive the SanaMente intervention. Participants will be enrolled into peer-led groups of approximately 6-10 individuals and will complete the 6-8 week program. The study is designed to evaluate feasibility, acceptability, and preliminary effectiveness; therefore, no randomization or comparison group is included.

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 15, 2026
• Study Start: March 6, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)