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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 cult

Первичные конечные точки

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

Вторичные конечные точки (6)

• Perceived stress as assessed by the Perceived Stress Scale (PSS-10) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)]
• Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ) [Срок оценки: Baseline, mid program (week 3-4), post-program (week 6-8)]
• Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ) [Срок оценки: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)]
• Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS) [Срок оценки: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• La Clinica del Pueblo — Carbondale

Идентификаторы

NCT: NCT07705776 · 25-0557 · 2025*1053

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗