Depression and/or Anxiety in the Mild-to-moderate RangeSanaMenteNCT07705776
SanaMente: A Peer-Led Program to Reduce Health Disparities in Rural Latino/a Communities
A study testing SanaMente in people with Depression and/or Anxiety in the Mild-to-moderate Range and Stress (Psychology), run by University of Colorado, Boulder at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression and/or Anxiety in the Mild-to-moderate Range, Stress (Psychology), Chronic Medical Illness
- What is being tested?
- SanaMente
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2026to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
La Clinica del Pueblo
Carbondale, Colorado, 81623
Jenny Lang, Clinical Director, FNP, 9706183841, jenny@peoplesclinic.care
About this study
Official title: SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino/a Communities
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Depression and/or Anxiety in the Mild-to-moderate Range, Stress (Psychology), Chronic Medical Illness
- Being tested
- SanaMente
- Keywords
- rural, Peer-led intervention, Chronic disease, Latino/a mental health
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SanaMenteBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| SanaMente Program | Experimental | 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. Receives: Behavioral: SanaMente |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
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.
Measured: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
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.
Measured: Baseline and Post-Program (week6-8)
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.
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
Diastolic Blood Pressure
Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using standardized clinical procedures.
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
Resting Heart Rate
Resting heart rate will be measured in beats per minute (bpm) using standardized clinical procedures.
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
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 (%).
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
Total Cholesterol
Fasting total cholesterol will be measured in mg/dL.
Measured: Changes from baseline to post-program (week 6-8) will be evaluated.
LDL Cholesterol
Fasting low-density lipoprotein (LDL) cholesterol will be measured in mg/dL.
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
HDL Cholesterol
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
Triglycerides
Fasting triglycerides will be measured in mg/dL.
Measured: Changes from Baseline and Post-Program (week6-8) will be evaluated
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT) will be assessed in fasting blood samples and reported in U/L. ALT is a marker of hepatocellular injury.
Measured: Changes from baseline to post-program (week 6-8) will be evaluated.
Electrolytes
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.
Measured: Changes from baseline to post-program (week 6-8) will be evaluated.
Metabolic Function
Metabolic function will be assessed using fasting plasma glucose (mg/dL), obtained from fasting blood samples as an indicator of glycemic status..
Measured: Changes from baseline to post-program (week 6-8) will be evaluated.
Aspartate aminotransferase (AST)
Aspartate aminotransferase (AST) will be assessed in fasting blood samples and reported in U/L. AST is a marker of hepatocellular injury.
Measured: Changes from Baseline to Post-program (week 6-8) will be evaluated
Total bilirubin
Total bilirubin will be assessed in fasting blood samples and reported in mg/dL. Total bilirubin is a marker of hepatic excretory function.
Measured: Changes from Baseline to post-program (week 6-8) will be evaluated
Serum albumin
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.
Measured: Changes from Baseline to post-program (week 6-8) will be evaluated
Serum creatinine
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.
Measured: Changes from Baseline to post-program (week 6-8) will be evaluated
Blood urea nitrogen (BUN)
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.
Measured: Changes from Baseline to post-program (weeks 6-8) will be evaluated
Secondary outcomes (6)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
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.
Measured: Baseline, mid program (week 3-4), post-program (week 6-8)
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.
Measured: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
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.
Measured: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start6 Mar 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression and/or Anxiety in the Mild-to-moderate RangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label feasibility and pilot 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. The study is designed to evaluate feasibility, acceptability, and preliminary effectiveness; therefore, no randomization or comparison group is included.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- La Clinica del Pueblo
- Responsible party
- Principal investigator, Anahí Collado, University of Colorado, Boulder
- Investigators
- Anahi Collado, PhD, Principal investigator, University of Colorado, Boulder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705776
- Sponsor's protocol ID
- 25-0557
- Other IDs
- 2025*1053
- Acronym
- SanaMente
- Status last verified
- Jul 2026
- First submitted
- 29 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SanaMente: A Peer-Led, Evidence-Based Mental Health and Lifestyle Program to Reduce Health Disparities in Rural Latino/a Communities
- ClinicalTrials.gov ID
- NCT07705776
- Acronym / sponsor ID
- SanaMente / 25-0557
- Conditions
- Depression and/or Anxiety in the Mild-to-moderate Range, Stress (Psychology), Chronic Medical Illness
- Keywords
- rural, Peer-led intervention, Chronic disease, Latino/a mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- La Clinica del Pueblo
- Study start
- 6 Mar 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label feasibility and pilot 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. The study is designed to evaluate feasibility, acceptability, and preliminary effectiveness; therefore, no randomization or comparison group is included.
| Arm | Type | Receives |
|---|---|---|
| SanaMente Program | Experimental | Behavioral: SanaMenteThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SanaMenteSanaMente 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. | Behavioural | SanaMente Program |
Primary outcome
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)
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Changes from baseline to post-program (week 6-8) will be evaluated.
Fasting total cholesterol will be measured in mg/dL.
LDL Cholesterol
Time frame: 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
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting high-density lipoprotein (HDL) cholesterol will be measured in mg/dL.
Triglycerides
Time frame: Changes from Baseline and Post-Program (week6-8) will be evaluated
Fasting triglycerides will be measured in mg/dL.
Alanine aminotransferase (ALT)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
6 secondary outcomes
Perceived stress as assessed by the Perceived Stress Scale (PSS-10)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Physical activity as assessed by the International Physical Activity Questionnaire (IPAQ)
Time frame: Baseline, mid program (week 3-4), post-program (week 6-8)
Dietary habits as assessed by the Dietary Screener Questionnaire (DSQ)
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Experiences of discrimination as assessed by the Everyday Discrimination Scale (EDS)
Time frame: Baseline, Mid-Program (Week 3-4), and Post-Program (Week 6-8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anahi Collado, PhD principal investigator
University of Colorado, Boulder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SanaMente in people with Depression and/or Anxiety in the Mild-to-moderate Range and Stress (Psychology), run by University of Colorado, Boulder at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonella Onofrietti Magrassi, PhD (15417807253, antonella.onofrietti@colorado.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.