SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino/a Communities
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
时间窗: 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)
时间窗: 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 Weight
时间窗: 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.
Systolic Blood Pressure
时间窗: 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.
Diastolic Blood Pressure
时间窗: 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.
Resting Heart Rate
时间窗: 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.
Glycemic control as assessed by Hemoglobin A1c (HbA1c)
时间窗: 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 Cholesterol
时间窗: Changes from baseline to post-program (week 6-8) will be evaluated.
Fasting total cholesterol will be measured in mg/dL.
LDL Cholesterol
时间窗: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg/dL.
HDL Cholesterol
时间窗: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
Triglycerides
时间窗: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting triglycerides will be measured in mg/dL.
Alanine aminotransferase (ALT)
时间窗: 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.
Electrolytes
时间窗: 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.
Metabolic Function
时间窗: 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..
Aspartate aminotransferase (AST)
时间窗: 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 bilirubin
时间窗: 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.
Serum albumin
时间窗: 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.
Serum creatinine
时间窗: 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.
Blood urea nitrogen (BUN)
时间窗: 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.
次要结局
- 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))
- Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)(Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8))
研究者
Anahí Collado
Assistant Research Professor
University of Colorado, Boulder