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

10. Juli 2026 aktualisiert von: Anahí Collado, University of Colorado, Boulder

SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino/a Communities

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

This Stage IB feasibility and pilot study is designed to refine and evaluate the SanaMente program, a culturally tailored, peer-led intervention developed to address the intersecting mental and physical health needs of rural Latinx adults living with chronic medical conditions. The study will assess implementation processes and generate preliminary evidence to inform a future, fully powered efficacy trial.

The intervention will be delivered by bilingual peer mentors who will receive standardized training prior to facilitating small group sessions. Throughout the study, implementation outcomes-including recruitment, retention, attendance, intervention fidelity, and participant engagement-will be monitored to evaluate the practicality of delivering the program in rural community settings.

A mixed-methods evaluation will be used to examine both implementation and participant outcomes. Quantitative analyses will estimate changes in mental health symptoms, health behaviors, and overall well-being over the course of the intervention, with effect size estimates used to inform the design and sample size of future studies. Qualitative data collected from participant feedback will be analyzed to identify factors influencing program engagement, perceived benefits, barriers to participation, and recommendations for improving program content and delivery.

Study findings will be used to optimize the SanaMente intervention, enhance its cultural relevance and implementation strategies, and establish the feasibility of conducting a larger randomized controlled trial to evaluate its effectiveness.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Vereinigte Staaten
    • Colorado
      • Carbondale, Colorado, Vereinigte Staaten, 81623
        • Rekrutierung
        • La Clinica del Pueblo
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: SanaMente Program
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.
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Zeitfenster: 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.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Zeitfenster: 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.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Body Weight
Zeitfenster: Baseline 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.
Baseline and Post-Program (week6-8)
Systolic Blood Pressure
Zeitfenster: Changes 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.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Diastolic Blood Pressure
Zeitfenster: Changes 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.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Resting Heart Rate
Zeitfenster: Changes 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.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Glycemic control as assessed by Hemoglobin A1c (HbA1c)
Zeitfenster: 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 (%).
Changes from Baseline and Post-Program (week6-8) will be evaluated
Total Cholesterol
Zeitfenster: Changes from baseline to post-program (week 6-8) will be evaluated.
Fasting total cholesterol will be measured in mg/dL.
Changes from baseline to post-program (week 6-8) will be evaluated.
LDL Cholesterol
Zeitfenster: Changes from Baseline and Post-Program (week6-8) will be evaluated
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
Zeitfenster: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Triglycerides
Zeitfenster: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting triglycerides will be measured in mg/dL.
Changes from Baseline and Post-Program (week6-8) will be evaluated
Alanine aminotransferase (ALT)
Zeitfenster: 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.
Changes from baseline to post-program (week 6-8) will be evaluated.
Electrolytes
Zeitfenster: Changes 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.
Changes from baseline to post-program (week 6-8) will be evaluated.
Metabolic Function
Zeitfenster: Changes 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..
Changes from baseline to post-program (week 6-8) will be evaluated.
Aspartate aminotransferase (AST)
Zeitfenster: 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.
Changes from Baseline to Post-program (week 6-8) will be evaluated
Total bilirubin
Zeitfenster: Changes 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.
Changes from Baseline to post-program (week 6-8) will be evaluated
Serum albumin
Zeitfenster: Changes 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.
Changes from Baseline to post-program (week 6-8) will be evaluated
Serum creatinine
Zeitfenster: Changes 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.
Changes from Baseline to post-program (week 6-8) will be evaluated
Blood urea nitrogen (BUN)
Zeitfenster: 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.
Changes from Baseline to post-program (weeks 6-8) will be evaluated

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
Zeitfenster: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Perceived Stress Scale-10 (PSS-10). The PSS-10 is a 10-item self-report measure that assesses the degree to which situations in one's life are appraised as stressful during the past month. Total scores range from 0 to 40, with higher scores indicating greater perceived stress. Change in total PSS-10 score from baseline to post-program will be evaluated.
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)
Zeitfenster: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Behavioral Activation for Depression Scale-Short Form (BADS-SF). The BADS-SF is a self-report measure of behavioral activation and avoidance associated with depression. Total scores range from 0 to 54, with higher scores indicating greater behavioral activation. Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
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)
Zeitfenster: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; 12-item, self-administered version). The WHODAS 2.0 is a 12-item self-report measure assessing disability and functioning across six domains of daily life. Total scores range from 0 to 48 using simple scoring, with higher scores indicating greater disability. Measurements will be obtained at baseline, mid-program, and post-program, and changes in total score over time will be evaluated.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
Zeitfenster: Baseline, mid program (week 3-4), post-program (week 6-8)
International Physical Activity Questionnaire (IPAQ; Short Form). The IPAQ is a validated self-report instrument designed to assess health-related physical activity across countries. The short form includes 4 items assessing frequency and duration of vigorous activity, moderate activity, walking, and sitting during the last 7 days. Physical activity will be summarized as total metabolic equivalent (MET)-minutes per week. Higher values indicate greater physical activity.
Baseline, mid program (week 3-4), post-program (week 6-8)
Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)
Zeitfenster: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Dietary Screener Questionnaire (DSQ). The DSQ is a self-report instrument developed to assess dietary intake patterns over the past 30 days, including frequency of consumption of fruits, vegetables, fiber, whole grains, dairy, added sugars, and other dietary components. The DSQ is used to estimate intake of specific food groups rather than generate a single total score. Higher estimated values indicate greater consumption of the respective dietary components being assessed.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)
Zeitfenster: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Everyday Discrimination Scale (EDS). The EDS is a self-report measure assessing the frequency of routine experiences of unfair treatment and discrimination in daily life. The standard scale includes multiple items rated on a Likert-type frequency scale, with response options typically ranging from "never" to "almost every day." Total scores are calculated by summing item responses, with higher scores indicating greater perceived discrimination.
Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)
Zeitfenster: Post-program (weeks 6-8)
Participant satisfaction with the SanaMente program will be assessed using the Client Satisfaction Questionnaire (CSQ-8). Higher scores indicate greater satisfaction with the program and services received.
Post-program (weeks 6-8)
Program usability and acceptability
Zeitfenster: Post-program (week 6-8)
Participants will complete an investigator-developed exit survey assessing the program's usability, cultural relevance, perceived impact, and recommendations for improvement.
Post-program (week 6-8)
Participant demographic Characteristics
Zeitfenster: baseline
Demographic information, including age, sex, gender identity, education, country of origin, language preference, employment status, and other background characteristics, will be collected to describe the study population and explore associations with study outcomes.
baseline
Suicide risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Screener
Zeitfenster: As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
Suicide risk will be assessed using the Columbia Suicide Severity Rating Scale (C-SSRS) Screener to identify suicidal ideation and behaviors and facilitate appropriate safety referrals when indicated. This is a safety assessment and not an efficacy outcome.
As clinically indicated throughout study participation (baseline, mid-program week 3-4, and post-program week 6-8)
Alcohol Use Disorders Identification Test (AUDIT)
Zeitfenster: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Alcohol use will be assessed among participants who endorse current alcohol use using the Alcohol Use Disorders Identification Test (AUDIT). The AUDIT is a validated 10-item self-report questionnaire that assesses hazardous and harmful alcohol consumption and alcohol-related problems.
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Drug Use Disorders Identification Test (DUDIT)
Zeitfenster: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Drug use will be assessed among participants who endorse current drug use using the Drug Use Disorders Identification Test (DUDIT). The DUDIT is a validated self-report questionnaire that assesses the frequency and severity of drug use and drug-related problems.
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Fagerström Test for Nicotine Dependence (FTND)
Zeitfenster: Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.
Nicotine dependence will be assessed among participants who endorse current tobacco or nicotine use using the Fagerström Test for Nicotine Dependence (FTND). The FTND is a validated self-report questionnaire that assesses the severity of nicotine dependence.
Baseline, Mid-program (weeks 3-4) and Post-Program (weeks 6-8) as applicable. Changes in substance use behaviors from baseline to mid- program and post-program will be evaluated among participants who complete the applicable assessments.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Colorado, Boulder

Mitarbeiter

La Clinica del Pueblo

Ermittler

  • Hauptermittler: Anahi Collado, PhD, University of Colorado, Boulder

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. März 2026

Primärer Abschluss (Geschätzt)

30. September 2026

Studienabschluss (Geschätzt)

10. Dezember 2026

Studienanmeldedaten

Zuerst eingereicht

29. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juli 2026

Zuerst gepostet (Tatsächlich)

15. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25-0557
  • 2025*1053 (Andere Zuschuss-/Finanzierungsnummer: Colorado Department of Public Health and Environment Health Disparities and Community Grant Program)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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