[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07705776":3,"trial-entities:NCT07705776":181,"trial-summary:NCT07705776":188},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":41,"secondary_outcomes":106,"sex":126,"minimum_age":127,"maximum_age":128,"healthy_volunteers":129,"eligibility_criteria":130,"std_ages":145,"locations":148,"central_contacts":164,"overall_officials":173,"references":176,"see_also_links":177},"NCT07705776","25-0557","SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino\u002Fa Communities","SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino\u002Fa Communities","RECRUITING","2026-12-10","2026-07","2026-07-15","2026-03-06","University of Colorado, Boulder","OTHER",false,"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\u002Fa adults with chronic medical conditions and mental health concerns. The main questions it aims to answer are:\n\n* Is the SanaMente program feasible and acceptable for rural Latino\u002Fa adults with chronic medical conditions and mental health concerns?\n* 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?\n\nThis is a single-arm pilot study without comparison group.\n\nParticipants will:\n\n* Participate in the 6-8 week SanaMente peer-led group program.\n* Complete surveys at baseline, mid-program, and post-program assessing mental health, lifestyle behaviors, overall well-being, and program satisfaction.\n* 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.","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.\n\nThe 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.\n\nA 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.\n\nStudy 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.",[19,20,21],"Depression and\u002For Anxiety in the Mild-to-moderate Range","Stress (Psychology)","Chronic Medical Illness",[23,24,25,26],"rural","Peer-led intervention","Chronic disease","Latino\u002Fa mental health","INTERVENTIONAL","SUPPORTIVE_CARE",[30],"NA",{"count":32,"type":33},40,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","SanaMente","SanaMente is a culturally responsive, peer-led behavioral program designed to support mental health and promote healthy lifestyle behaviors among rural Latino\u002Fa 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.",[40],"SanaMente Program",[42,46,49,53,57,60,63,66,70,73,76,79,82,85,88,92,96,99,102],{"measure":43,"description":44,"timeFrame":45},"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.","Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)",{"measure":47,"description":48,"timeFrame":45},"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.",{"measure":50,"description":51,"timeFrame":52},"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.","Baseline and Post-Program (week6-8)",{"measure":54,"description":55,"timeFrame":56},"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.","Changes from Baseline and Post-Program (week6-8) will be evaluated",{"measure":58,"description":59,"timeFrame":56},"Diastolic Blood Pressure","Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.",{"measure":61,"description":62,"timeFrame":56},"Resting Heart Rate","Resting heart rate will be measured in beats per minute (bpm) using standardized clinical procedures.",{"measure":64,"description":65,"timeFrame":56},"Glycemic control as assessed by Hemoglobin A1c (HbA1c)","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 (%).",{"measure":67,"description":68,"timeFrame":69},"Total Cholesterol","Fasting total cholesterol will be measured in mg\u002FdL.","Changes from baseline to post-program (week 6-8) will be evaluated.",{"measure":71,"description":72,"timeFrame":56},"LDL Cholesterol","Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg\u002FdL.",{"measure":74,"description":75,"timeFrame":56},"HDL Cholesterol","Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg\u002FdL.",{"measure":77,"description":78,"timeFrame":56},"Triglycerides","Fasting triglycerides will be measured in mg\u002FdL.",{"measure":80,"description":81,"timeFrame":69},"Alanine aminotransferase (ALT)","Alanine aminotransferase (ALT) will be assessed in fasting blood samples and reported in U\u002FL. ALT is a marker of hepatocellular injury.",{"measure":83,"description":84,"timeFrame":69},"Electrolytes","Electrolyte balance will be assessed using serum sodium (mEq\u002FL), potassium (mEq\u002FL), and chloride (mEq\u002FL), obtained from fasting blood samples. These measures reflect systemic fluid and electrolyte homeostasis.",{"measure":86,"description":87,"timeFrame":69},"Metabolic Function","Metabolic function will be assessed using fasting plasma glucose (mg\u002FdL), obtained from fasting blood samples as an indicator of glycemic status..",{"measure":89,"description":90,"timeFrame":91},"Aspartate aminotransferase (AST)","Aspartate aminotransferase (AST) will be assessed in fasting blood samples and reported in U\u002FL. AST is a marker of hepatocellular injury.","Changes from Baseline to Post-program (week 6-8) will be evaluated",{"measure":93,"description":94,"timeFrame":95},"Total bilirubin","Total bilirubin will be assessed in fasting blood samples and reported in mg\u002FdL. Total bilirubin is a marker of hepatic excretory function.","Changes from Baseline to post-program (week 6-8) will be evaluated",{"measure":97,"description":98,"timeFrame":95},"Serum albumin","Serum albumin will be assessed in fasting blood samples and reported in g\u002FdL. Serum albumin is a marker of hepatic synthetic function and nutritional status.",{"measure":100,"description":101,"timeFrame":95},"Serum creatinine","Serum creatinine will be assessed in fasting blood samples and reported in mg\u002FdL. Serum creatinine is a marker of glomerular filtration and renal function.",{"measure":103,"description":104,"timeFrame":105},"Blood urea nitrogen (BUN)","Blood urea nitrogen (BUN) will be assessed in fasting blood samples and reported in mg\u002FdL. BUN is a marker of renal function and protein metabolism.","Changes from Baseline to post-program (weeks 6-8) will be evaluated",[107,110,113,116,120,123],{"measure":108,"description":109,"timeFrame":45},"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.",{"measure":111,"description":112,"timeFrame":45},"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.",{"measure":114,"description":115,"timeFrame":45},"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.",{"measure":117,"description":118,"timeFrame":119},"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.","Baseline, mid program (week 3-4), post-program (week 6-8)",{"measure":121,"description":122,"timeFrame":45},"Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)","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.",{"measure":124,"description":125,"timeFrame":45},"Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)","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.","ALL","18 Years",null,true,{"inclusion":131,"exclusion":141,"raw_text":144},[132,133,134,135,136,137,138,139,140],"Adults aged 18 years or older.","Identify as Hispanic\u002FLatino\u002Fa.","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.",[142,143],"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.","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Identify as Hispanic\u002FLatino\u002Fa.\n* Patients of La Clínica del Pueblo in Carbondale, Colorado.\n* Spanish-speaking (bilingual Spanish-English speakers are eligible).\n* Interest in improving your physical and emotional well-being.\n* 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.\n* Experiencing or at risk for stress, low mood, or anxiety (formal diagnosis not required)\n* Willingness and ability to participate in the SanaMente program.\n* 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.\n\nExclusion Criteria:\n\n* Individuals who are unable to provide informed consent.\n* Individuals who are unwilling or unable to participate in the group-based or one-to-one SanaMente sessions.",[146,147],"ADULT","OLDER_ADULT",[149],{"facility":150,"status":8,"city":151,"state":152,"zip":153,"country":154,"contacts":155,"geoPoint":161},"La Clinica del Pueblo","Carbondale","Colorado","81623","United States",[156],{"name":157,"role":158,"phone":159,"email":160},"Jenny Lang, Clinical Director, FNP","CONTACT","9706183841","jenny@peoplesclinic.care",{"lat":162,"lon":163},39.40221,-107.21116,[165,169],{"name":166,"role":158,"phone":167,"email":168},"Antonella Onofrietti Magrassi, PhD","15417807253","antonella.onofrietti@colorado.edu",{"name":170,"role":158,"phone":171,"email":172},"Anahi Collado, PhD","3052835243","anahi.collado@colorado.edu",[174],{"name":170,"affiliation":13,"role":175},"PRINCIPAL_INVESTIGATOR",[],[178],{"label":179,"url":180},"Related Info","https:\u002F\u002Fcrowninstitute.colorado.edu\u002Fresearch-projects\u002Fsanamente",{"nct_id":4,"conditions":182,"biomarkers":187},[183,184,185,186],"Anxiety","Chronic mental disorder","Depression","Stress",[],{"nct_id":4,"found":129,"summary":189,"prompt_version":199},{"design":190,"status":191,"heading":192,"summary":193,"follow_up":194,"word_count":195,"commitments":196,"compensation":197,"drugs_mentioned":198},"This is a single-arm pilot study, meaning all 40 participants will receive the SanaMente program without a comparison group. The study is designed to refine and evaluate the program.","completed","SanaMente: A Peer-Led Program for Rural Latino\u002Fa Communities","This study is testing a program called SanaMente, which is a peer-led (meaning led by people with similar experiences) program designed to help rural Latino\u002Fa adults who have chronic medical conditions and mental health concerns like depression, anxiety, or stress. The program aims to improve mental health and promote healthy lifestyle behaviors. Researchers want to see if SanaMente is practical and well-received by participants, and if it helps reduce symptoms of depression and anxiety, and affects body weight. You may be able to join if you are an adult aged 18 or older, identify as Hispanic\u002FLatino\u002Fa, speak Spanish, are a patient at La Clínica del Pueblo in Carbondale, Colorado, and are interested in improving your well-being while managing chronic health conditions. The study's current status is unclear.","Your depression and anxiety will be measured at the end of the 6-8 week program. Body weight will also be measured at the end of the program.",127,"You would participate in the 6-8 week SanaMente peer-led group program. Your depression, anxiety, and body weight will be measured at the beginning, middle, and end of the program.","Not stated in the trial record.",[37],"v2"]