SanaMente: A Peer-Led Program for Rural Latino/a Communities

This study is testing a program called SanaMente, which is a peer-led (meaning led by people with similar experiences) program designed to help rural Latino/a adults who have chronic medical conditions and mental health concerns like depression, anxiety, or stress. The program aims to improve mental health and promote healthy lifestyle behaviors. Researchers want to see if SanaMente is practical and well-received by participants, and if it helps reduce symptoms of depression and anxiety, and affects body weight. You may be able to join if you are an adult aged 18 or older, identify as Hispanic/Latino/a, speak Spanish, are a patient at La Clínica del Pueblo in Carbondale, Colorado, and are interested in improving your well-being while managing chronic health conditions. The study's current status is unclear.

Study design
This is a single-arm pilot study, meaning all 40 participants will receive the SanaMente program without a comparison group. The study is designed to refine and evaluate the program.
What's involved
You would participate in the 6-8 week SanaMente peer-led group program. Your depression, anxiety, and body weight will be measured at the beginning, middle, and end of the program.
Compensation
Not stated in the trial record.
Follow-up
Your depression and anxiety will be measured at the end of the 6-8 week program. Body weight will also be measured at the end of the program.

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NCT07705776

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

Recruiting
NAAges 18+InterventionalSupportive care
University of Colorado, Boulder
~40 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:SanaMente

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Measured over Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
+18 more outcomes measured
Depression and/or Anxiety in the Mild-to-moderate Range
Stress (Psychology)
Chronic Medical Illness
1 sites across 1 states
Colorado1
  • Anahi Collado, PhD · PRINCIPAL_INVESTIGATOR · University of Colorado, Boulder
Antonella Onofrietti Magrassi, PhD
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Eligibility criteria

Inclusion

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

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.
  • Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

    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.

  • Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

    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.

  • Body WeightBaseline and Post-Program (week6-8)

    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.

  • Systolic Blood PressureChanges from Baseline and Post-Program (week6-8) will be evaluated

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

  • Diastolic Blood PressureChanges from Baseline and Post-Program (week6-8) will be evaluated

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

  • Resting Heart RateChanges from Baseline and Post-Program (week6-8) will be evaluated

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

  • Glycemic control as assessed by Hemoglobin A1c (HbA1c)Changes from Baseline and Post-Program (week6-8) will be evaluated

    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 (%).

  • Total CholesterolChanges from baseline to post-program (week 6-8) will be evaluated.

    Fasting total cholesterol will be measured in mg/dL.

  • LDL CholesterolChanges from Baseline and Post-Program (week6-8) will be evaluated

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

  • HDL CholesterolChanges from Baseline and Post-Program (week6-8) will be evaluated

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

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

    Fasting triglycerides will be measured in mg/dL.

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

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

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

    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.

  • Metabolic FunctionChanges from baseline to post-program (week 6-8) will be evaluated.

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

  • Aspartate aminotransferase (AST)Changes from Baseline to Post-program (week 6-8) will be evaluated

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

  • Total bilirubinChanges from Baseline to post-program (week 6-8) will be evaluated

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

  • Serum albuminChanges from Baseline to post-program (week 6-8) will be evaluated

    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.

  • Serum creatinineChanges from Baseline to post-program (week 6-8) will be evaluated

    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.

  • Blood urea nitrogen (BUN)Changes from Baseline to post-program (weeks 6-8) will be evaluated

    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.