Recruiting

SanaMente

Sponsor:

University of Colorado, Boulder

Code:

NCT07705776

Conditions

Depression and/or Anxiety in the Mild-to-moderate Range

Stress (Psychology)

Chronic Medical Illness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SanaMente

Study Details

Brief summary:

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.

Conditions

Depression and/or Anxiety in the Mild-to-moderate Range

Stress (Psychology)

Chronic Medical Illness

Study ID

NCT07705776

Start date

Mar 6, 2026

Status verified date

Jul, 2026

Completion date

Dec 10, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8) ]
  • Anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) [ Time Frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8) ]
  • Body Weight [ Time Frame: Baseline and Post-Program (week6-8) ]
  • Systolic Blood Pressure [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • Diastolic Blood Pressure [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • Resting Heart Rate [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • Glycemic control as assessed by Hemoglobin A1c (HbA1c) [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • Total Cholesterol [ Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated. ]
  • LDL Cholesterol [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • HDL Cholesterol [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • Triglycerides [ Time Frame: Changes from Baseline and Post-Program (week6-8) will be evaluated ]
  • Alanine aminotransferase (ALT) [ Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated. ]
  • Electrolytes [ Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated. ]
  • Metabolic Function [ Time Frame: Changes from baseline to post-program (week 6-8) will be evaluated. ]
  • Aspartate aminotransferase (AST) [ Time Frame: Changes from Baseline to Post-program (week 6-8) will be evaluated ]
  • Total bilirubin [ Time Frame: Changes from Baseline to post-program (week 6-8) will be evaluated ]
  • Serum albumin [ Time Frame: Changes from Baseline to post-program (week 6-8) will be evaluated ]
  • Serum creatinine [ Time Frame: Changes from Baseline to post-program (week 6-8) will be evaluated ]
  • Blood urea nitrogen (BUN) [ Time Frame: Changes from Baseline to post-program (weeks 6-8) will be evaluated ]

Central Contacts and Locations

Central contacts

Antonella Onofrietti Magrassi, PhD

15417807253antonella.onofrietti@colorado.edu

Anahi Collado, PhD

3052835243anahi.collado@colorado.edu

Locations

La Clinica del Pueblo

Recruiting

Carbondale, Colorado, United States, 81623

Contacts

Jenny Lang, Clinical Director, FNP

9706183841jenny@peoplesclinic.care

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • rural
  • Peer-led intervention
  • Chronic disease
  • Latino/a mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2026-07-15.