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.
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).
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.
Single group
SanaMente
BehavioralSanaMente 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.
Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
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)
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
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
Systolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures. Change from baseline to post-program will be evaluated.
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
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.
Behavioral activation as assessed by the Behavioral Activation for Depression Scale-Short Form (BADS-SF)
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.
Disability and functioning as assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
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.
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
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.
Participant satisfaction as assessed by the Client Satisfaction Questionnaire (CSQ-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.
Program usability and acceptability
Participants will complete an investigator-developed exit survey assessing the program's usability, cultural relevance, perceived impact, and recommendations for improvement.
Participant demographic Characteristics
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.
Suicide risk as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Screener
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.
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University of Colorado, Boulder
Lead sponsor
La Clinica del Pueblo
Collaborator
