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

2026年7月10日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Colorado
      • Carbondale、Colorado、美国、81623
        • 招聘中
        • La Clinica del Pueblo
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
行为的：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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)

其他结果措施

结果测量
措施说明
大体时间
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-8)
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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)
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Colorado, Boulder

合作者

La Clinica del Pueblo

调查人员

  • 首席研究员：Anahi Collado, PhD、University of Colorado, Boulder

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月6日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年12月10日

研究注册日期

首次提交

2026年6月29日

首先提交符合 QC 标准的

2026年7月10日

首次发布 (实际的)

2026年7月15日

研究记录更新

最后更新发布 (实际的)

2026年7月15日

上次提交的符合 QC 标准的更新

2026年7月10日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 25-0557
  • 2025*1053 (其他赠款/资助编号：Colorado Department of Public Health and Environment Health Disparities and Community Grant Program)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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