Lifestyle and Mindfulness Interventions for Mental Health Wellness

Recruiting at 1 trial location

Overseen By Nicole Clark, RDN

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Colorado State University

Disqualifiers: Severe emotional-behavioral disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

175 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve mental health and overall wellness for teens and their families in rural Southwest Colorado. It features a 12-session program called Health without Barriers/Salud sin Barreras, which includes nutrition and cooking classes, physical fitness activities, and mindfulness training. The goal is to help prevent chronic conditions like Type 2 Diabetes and support healthy lifestyle habits within the family. Families with at least one teenager aged 11-19 living in La Plata, Montezuma, or Archuleta Counties may be eligible to join. As an unphased trial, this study offers families a unique opportunity to enhance their well-being through innovative lifestyle programs.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on lifestyle and mindfulness interventions for mental health wellness.

What prior data suggests that this lifestyle and mindfulness intervention is safe for adolescents and their families?

Research has shown that lifestyle and mindfulness programs like Health Without Barriers/Salud Sin Barreras are generally safe and easy to follow. This program helps families enhance their mental and physical health by promoting healthy habits, managing stress, and reducing the risk of long-term illnesses like Type 2 Diabetes.

Participants in similar programs have experienced better overall health without major side effects. Because this program emphasizes lifestyle changes over medication, it typically presents fewer safety concerns. Participants often see positive outcomes, such as improved mental health and healthier living, with minimal risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Health without Barriers/Salud Sin Barreras" intervention because it offers a holistic, family-centered approach to mental health and chronic disease prevention, setting it apart from standard treatments like individual therapy or medication. This program uniquely integrates community-delivered sessions that combine nutrition education, cooking classes, physical fitness, and mindfulness training, targeting the whole family rather than just the individual. By tailoring the intervention to adolescents at risk for depression and chronic conditions, it addresses both mental and physical wellness in a culturally relevant way. This comprehensive approach has the potential to create lasting lifestyle changes and improve overall health outcomes.

What evidence suggests that the Health Without Barriers/Salud Sin Barreras program is effective for adolescent mental health and healthy weight?

Research has shown that community programs like Health Without Barriers/Salud Sin Barreras, which participants in this trial will experience, can improve teen mental health. Studies find that when families join programs focusing on healthy eating, exercise, and mindfulness, teens are less likely to face depression and long-term health issues like Type 2 Diabetes. Mindfulness activities link to better emotional health in teens. Additionally, involving parents and siblings creates a supportive environment that encourages healthy habits. This approach aims to foster positive changes that enhance both mental and physical health. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for families with at least one teenager aged 11-19 living in specific Colorado counties. It's not suitable for those with medical or psychological conditions that may pose a safety risk or hinder program benefits, such as severe emotional disturbances or substance abuse during sessions.

Inclusion Criteria

I have a teen aged 11-19 and we live in La Plata, Montezuma, or Archuleta Counties.

Exclusion Criteria

Adolescents will not take part in the program and/or research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the Colorado State University/Extension program team, could interfere with safety for themselves or others or interfere with the capability of the youth or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions).

Parents/guardians will not take part in the program and/or research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the CSU/Extension program team, could interfere with safety for themselves or others or interfere with the capability of their family or other participating families to potentially benefit from the program (e.g., using drugs or alcohol or under the use of drugs/alcohol during program sessions, aggressive or inappropriate behavior toward other participants).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-session community-delivered, family-based lifestyle intervention over 6 weeks, including nutrition/cooking sessions, physical fitness classes, and mindfulness training.

6 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for changes in mental/physical health and health behaviors, including eating behavior, glucose patterns, and physical activity.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Health without Barriers/Salud sin Barreras

Trial Overview

The study tests a family-based lifestyle and stress management program aimed at preventing chronic health issues like Type 2 Diabetes. It includes physical activities, nutritional education, parent guidance, and mindfulness techniques tailored to rural Southwest Colorado adolescents and their families.

How Is the Trial Designed?

Group I: Health without Barriers/ Salud Sin Barreras Experimental Treatment 6 Interventions

Health Without Barriers/Salud Sin Barreras is 12-session community-delivered, family-based lifestyle intervention to reduction the risk of for chronic diseases (i.e., T2D) in adolescence and to improve whole family health and wellness. The program is based upon a lifestyle intervention called the Healthy Living Program (HeLP), which includes 6 weekly 2 hour nutrition/cooking sessions through Cooking Matters and 6 weekly 2 hour Multidisciplinary Sessions that include parent education, a teen and sibling (ages 6-10 years) group physical fitness class, preschool curriculum for children 2-5 years of age, and a teen mindfulness curriculum called Learning 2 BREATHE. Health Without Barriers/Salud Sin Barreras has been tailored for adolescents at risk for depression and chronic diseases (i.e., T2D) in Southwest Colorado based on community input.

Health without Barriers/Salud sin Barreras is already approved in United States for the following indications:

Approved in United States as Health Without Barriers/Salud Sin Barreras for:

• Prevention of chronic health conditions (e.g., Type 2 Diabetes)
• Adolescent mental health support
• Healthy weight management

Who Is Running the Clinical Trial?

Colorado State University

Lead Sponsor

Trials

138

Recruited

38,200+

Colorado Health Foundation

Collaborator

Trials

3

Recruited

610+

Colorado State University Extension-La Plata County

Collaborator

Trials

2

Recruited

320+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Published Research Related to This Trial

Participants in a self-directed mental health care program showed a significant reduction in median monthly outpatient costs after implementing self-direction, indicating improved cost efficiency in mental health service utilization.

On average, participants used $182 per month from their 'Freedom Funds' to purchase nonclinical goods and services that supported their recovery, demonstrating a shift towards more personalized and individualized care without increasing overall costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service costs and mental health self-direction: Findings from consumer recovery investment fund self-directed care. Croft, B., Battis, K., Ostrow, L., et al.[2020]

Mindfulness-Based Interventions (MBIs) have been shown to be effective for patients with both psychiatric issues and chronic physical health conditions, highlighting their versatility in healthcare.

Despite their proven benefits, the adoption of MBIs in clinical settings is slow, necessitating better integration into medical education, more qualified instructors, and further research on their effectiveness and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How can mindfulness contribute to health care?] Speckens, AEM., Cillessen, L.[2021]

This study is testing the effectiveness of an 8-week mindfulness-based intervention (MBI) for adolescents with chronic health conditions, comparing in-person delivery to eHealth delivery, with a focus on improving mindfulness skills, mood, anxiety, self-esteem, and stress levels.

The research aims to show that both delivery methods will be equally effective and feasible, potentially increasing access to MBIs for teens with mobility issues or those living in areas without in-person programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In-Person Versus eHealth Mindfulness-Based Intervention for Adolescents With Chronic Illness: Protocol for a Randomized Controlled Trial. Chadi, N., Kaufman, M., Weisbaum, E., et al.[2020]

The health fair in Calexico, California, served 293 participants, primarily monolingual Spanish speakers, revealing significant health concerns: 91.1% were overweight or obese, and 37.8% had hypertension, highlighting the urgent need for health interventions in underserved communities.

This project demonstrates a successful model for interdisciplinary collaboration between medical and pharmacy students and community partners, which can be replicated in other areas to address border health issues and improve access to local health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and Evaluation of a Recurring Interdisciplinary Community Health Fair in a Remote U.S.-Mexico Border Community. Lee, J., McKennett, M., Rodriguez, X., et al.[2021]

A community needs assessment involving 31 overweight/obese Mexicans in New York City identified key themes for a culturally-tailored weight loss program, SANOS, emphasizing the importance of family support and group motivation for behavior change.

The study highlighted ecological factors, such as acculturation and socioenvironmental barriers, that should be considered when designing effective dietary and lifestyle interventions for Mexican Americans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Culturally Responsive Lifestyle Intervention for Overweight/Obese U.S. Mexicans. Leng, J., Lui, F., Narang, B., et al.[2023]

Over 50% of adults in Chile face high cardiovascular risk, highlighting an urgent need for effective prevention and treatment strategies for chronic diseases.

Improving patient compliance with treatment can be achieved by simplifying medication regimens and implementing complex behavioral interventions, as demonstrated by the promising results of the 'Mírame' program in Chile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention and patient's compliance. Two key factors to deal with non communicable chronic diseases]. Téllez, A.[2019]

A lifestyle and weight loss intervention was successfully adapted for individuals with serious mental health conditions, incorporating specific content and additional support to meet their unique needs.

The program was implemented consistently across various settings, showing good adherence to the protocol, which suggests that such interventions can be effectively delivered in mental health environments despite some challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering a lifestyle and weight loss intervention to individuals in real-world mental health settings: Lessons and opportunities. Yarborough, BJ., Janoff, SL., Stevens, VJ., et al.[2021]

A community-wide campaign (CWC) called Tu Salud ¡Sí Cuenta! significantly increased physical activity levels among Mexican Americans, with participants exposed to community health worker discussions and radio messages being 3.83 times more likely to meet physical activity guidelines.

Participants exposed to both radio and TV messages consumed 30% more portions of fruits and vegetables daily compared to those with no exposure, highlighting the campaign's effectiveness in promoting healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tu Salud, ¡Si Cuenta!: Exposure to a community-wide campaign and its associations with physical activity and fruit and vegetable consumption among individuals of Mexican descent. Reininger, BM., Mitchell-Bennett, L., Lee, M., et al.[2022]

The Wellness Recovery Action Planning (WRAP) intervention significantly reduced the self-reported need for and use of mental health services over time compared to a nutrition education course, based on a study of 143 participants over 8 months.

Both WRAP and nutrition education led to improvements in symptoms and recovery outcomes, but WRAP was particularly effective in promoting self-management and reducing reliance on formal mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Wellness Recovery Action Planning on service utilization and need in a randomized controlled trial. Cook, JA., Jonikas, JA., Hamilton, MM., et al.[2019]

The Healthy Amistad program effectively improved health behaviors among individuals with serious mental illnesses, leading to significant weight loss (150 pounds total among 11 members) and increased physical activity.

Participants reported better health outcomes, including a decrease in emergency room visits from 58% to 37% and an increase in life satisfaction from 76% to 88%, demonstrating the program's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Amistad: improving the health of people with severe mental illness. Martin, MB., Martin, SL.[2019]

Mindfulness-based programs (MBPs) significantly improve mental health outcomes such as anxiety, depression, and psychological distress compared to no intervention, based on a review of 136 trials involving 11,605 participants.

While MBPs show promise in promoting mental health, their effectiveness varies across different settings and populations, and there is no strong evidence of superiority over other active interventions, highlighting the need for further research to identify optimal conditions for their implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based programmes for mental health promotion in adults in nonclinical settings: A systematic review and meta-analysis of randomised controlled trials. Galante, J., Friedrich, C., Dawson, AF., et al.[2023]

A study involving 158 participants with severe and persistent mental illnesses identified 512 individualized health-related goals, which were categorized into five domains, demonstrating the diversity of health behaviors targeted in goal planning.

The existing goal taxonomy was successfully refined and validated, showing significant overlap with participant goals, indicating its applicability across various mental health conditions and enhancing the support provided by community pharmacists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Refining a taxonomy of goals planned between mental health consumers and community pharmacists. Stewart, V., McMillan, SS., Hu, J., et al.[2023]

The KoSiM program, which provided lifestyle interventions to mental health staff, led to positive changes in clinicians' approaches to physical health care and improved attitudes towards self-care and family wellbeing among participants.

The program was well-accepted by staff and resulted in a shift in workplace culture towards better integration of physical health care within mental health services, suggesting its potential for broader application in similar settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tackling change in mental health service delivery: A qualitative evaluation of a lifestyle program targeting mental health staff - Keeping our Staff in Mind (KoSiM). Watkins, A., Stein-Parbury, J., Curtis, J., et al.[2023]

A mindfulness-based mobile health intervention significantly reduced anxiety symptoms among young adult students during quarantine, showing a superior effect compared to a social support-based intervention (p = .024, between-group d = 0.72).

Both interventions improved depression symptoms, but mindfulness showed a trend towards greater benefit, and it was found to be more feasible and acceptable for participants, with high retention rates (>80%) in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based mobile health (mHealth) intervention among psychologically distressed university students in quarantine during the COVID-19 pandemic: A randomized controlled trial. Sun, S., Lin, D., Goldberg, S., et al.[2023]

A review of 16 studies involving Web-based mindfulness-based interventions (MBIs) for people with chronic physical health conditions showed positive effects on outcomes like pain acceptance and depressive symptoms compared to usual care.

Condition-specific symptoms, such as cancer-related fatigue and irritable bowel syndrome (IBS) symptoms, showed the largest improvements, indicating that tailored Web-based MBIs may effectively alleviate symptom burden for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for People With Physical Health Conditions: Systematic Review. Toivonen, KI., Zernicke, K., Carlson, LE.[2018]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06052943?term=clarity%20extension&viewType=Table&rank=8

NCT06052943 | Health Without Barriers/Salud Sin Barreras

Details for study NCT06052943, | ClinicalTrials.gov.

2.

learn.colostate.edu

learn.colostate.edu/health-without-barriers/

Health Without Barriers - Learn | CSU's Office Of ...

Health Without Barriers is a 6-week family program aimed at helping youth, ages 11-19 years old, and their family members feel happier and healthier.

3.

who.int

who.int/news-room/fact-sheets/detail/mental-health-strengthening-our-response

Mental health

Protective factors similarly occur throughout our lives and help build resilience. They include individual social and emotional skills, positive ...

4.

frontiersin.org

frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1241469/full

Community-based programs for youth with mental health ...

Background: approximately 14% of all adolescents globally cope with mental health conditions. However, community-based psychosocial services ...

5.

aamc.org

aamc.org/about-us/mission-areas/health-care/exploring-barriers-mental-health-care-us

Exploring Barriers to Mental Health Care in the U.S.

This brief looks at the mental health crisis — including workforce shortages, lack of insurance parity, and how to fix it.

6.

peearz.com

peearz.com/trialsindex?nctid=NCT06052943

Health Without Barriers/Salud Sin Barreras

The intervention is a lifestyle program that addresses healthy lifestyle habits within the family context to support adolescent mental health (mindfulness ...

7.

app.trialscreen.org

app.trialscreen.org/trials/health-barriers-salud-sin-barreras-trial-nct06052943

Health Without Barriers/Salud Sin Barreras

Participation in the program may lead to improved mental and physical health, healthier lifestyle habits, better stress management, and reduced risk of chronic ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03527641

United for Health: Type 2 Diabetes Prevention in Latino ...

This study pilots the feasibility and acceptability of a family-based lifestyle intervention for decreasing diabetes risk called "Salud sin Barreras" ...