Yoga for Mental Health in Black Adults

Overseen By Scherezade Mama, DRPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Active, Yoga, Pregnancy, 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: 16

Duration: 8 weeks

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a yoga-based program can help Black adults in Houston become more active, sit less, and improve their mental well-being. Participants will join the Harmony & Health program, a culturally adapted mind-body intervention, which includes in-person group sessions twice a week for eight weeks. The trial seeks Black adults who currently sit for more than six hours a day and exercise less than 150 minutes a week. Participants should feel comfortable with group activities and be classified as overweight. The study aims to develop a more culturally relevant approach to improving mental and physical health. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance community health practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Harmony & Health program is safe?

Research shows that the Harmony & Health program is generally safe for participants. Previous studies found that participants find the program easy to follow and well-received. Most people handle it well without major issues. The program includes physical activities and mental relaxation techniques and has been used successfully in other groups. The reviewed studies reported no serious problems or safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Harmony & Health program is unique because it focuses on using yoga as a holistic approach to improving mental health specifically in Black adults. Unlike standard treatments that often rely on medication or traditional therapy, this program provides a culturally tailored practice that combines physical activity and mindfulness, which can be more engaging and empowering. Researchers are excited about this approach because it not only addresses mental health through a non-traditional, accessible method but also has the potential to improve overall well-being by promoting physical health, stress reduction, and community support.

What evidence suggests that the Harmony & Health program is effective for improving mental health in Black adults?

Research shows that the Harmony & Health program, which participants in this trial will join, combines cultural and spiritual practices with mind-body techniques to improve mental health by reducing stress, depression, and anxiety. Studies have found that similar programs focusing on spirituality can enhance both physical and mental health. For example, Harmony & Health has successfully improved well-being and increased physical activity among various groups, including those in rural areas. By blending spirituality with mind-body practices, this program offers a promising way to boost overall mental health. Early results suggest it could be especially helpful for communities seeking health solutions that respect their cultural values. ^{2 3 6 7 8}

Who Is on the Research Team?

Scherezade Mama, DRPH

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for Black or African American adults over 18 who are not very active (less than 90 minutes of moderate to vigorous physical activity per week), sit a lot (6+ hours a day), have a BMI of at least 25, and can pass a basic health check or get doctor's approval. Participants must be comfortable with group activities, speak English, and give informed consent.

Inclusion Criteria

Able to read, speak, and write in English

Self-reports sedentary time ≥6 hours/day

Comfortable participating in group-based physical activity

Exclusion Criteria

I don't have conditions that prevent me from physical activity like a recent heart attack or bone issues.

Practicing yoga or enrolled in another program targeting physical activity, sedentary behavior, or weight loss

Self-reports sedentary time <6 hours/day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take part in the Harmony & Health program, attending in-person group health education sessions 2 times a week for 8 weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for psychosocial wellbeing and physical activity outcomes

15 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Harmony & Health program

Trial Overview The Harmony & Health program aims to reduce sitting time and boost both physical activity and mental wellbeing among Black adults through culturally tailored yoga-based sessions. The study will randomly assign participants to either the intervention or a control group.

How Is the Trial Designed?

Group I: Harmony & Health program Experimental Treatment 1 Intervention

Participants will take part in the Harmony \& Health program or participants will attend in-person group health education sessions 2 times a week for 8 weeks.

Harmony & Health program is already approved in United States for the following indications:

Approved in United States as Harmony & Health program for:

• Reducing sitting time
• Increasing physical activity
• Improving psychosocial wellbeing in Black adults

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

American Cancer Society (ACS)

Collaborator

Trials

1

Recruited

250+

Published Research Related to This Trial

A literature review found strong evidence supporting integrated mind-body wellness programs, such as yoga, tai chi, and mindfulness meditation, as effective complementary approaches to improve mental health.

A survey of 73 respondents from a mental health agency in northeast Georgia revealed that 86% were interested in wellness services, highlighting a significant demand for holistic approaches to enhance mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence and Feasibility of Implementing an Integrated Wellness Program in Northeast Georgia. Flanigan, A., Salm Ward, T.[2018]

Mind-body approaches, such as meditation and yoga, are effective in improving mental health symptoms like depression and anxiety, particularly among disadvantaged populations who may not have access to conventional treatments.

The review highlights that while racial and ethnic minorities use mind-body interventions less frequently, they still show significant engagement with complementary health approaches, indicating a potential pathway to enhance mental health care accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-Body Approaches to Treating Mental Health Symptoms Among Disadvantaged Populations: A Comprehensive Review. Burnett-Zeigler, I., Schuette, S., Victorson, D., et al.[2021]

Qualitative research involving 20 interviews with racial and ethnic minority adolescents revealed that promoting free yoga classes highlighting social, physical, and mental benefits can help overcome negative perceptions and encourage participation.

Emphasizing inclusivity in recruitment materials—addressing all genders and physical abilities—was identified as a key factor in facilitating engagement in yoga, which could ultimately improve mental health outcomes for underserved adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative investigation to inform yoga intervention recruitment practices for racial/ethnic minority adolescents in outpatient mental health treatment. Spadola, CE., Varga, LM., Fernandez, SB., et al.[2021]

The 'Harmony & Health' (HH) intervention, a mind-body program adapted for rural churchgoers, was found to be feasible and acceptable, effectively reducing perceived stress, depressive symptoms, and negative affect after an 8-week program involving overweight or obese adults.

Participants in the study, primarily women with a mean age of 49, showed significant improvements in mental health outcomes, indicating that integrating spirituality with mind-body practices can enhance psychosocial well-being in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A faith-based mind-body intervention to improve psychosocial well-being among rural adults. Mama, SK., Bhuiyan, N., Bopp, MJ., et al.[2022]

Participation in a culturally-adapted mind-body intervention significantly increased spirituality among urban African American adults, particularly those who attended at least 75% of the sessions, indicating the intervention's efficacy in enhancing spiritual well-being.

The study highlights the need for further adaptations of the intervention to better support spirituality and psychosocial health in rural populations, suggesting that different approaches may be necessary for diverse communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fostering spirituality and psychosocial health through mind-body practices in underserved populations. Bhuiyan, N., McNeill, LH., Bopp, M., et al.[2023]

The Harmony & Health (HH) intervention, a culturally adapted mind-body program, was feasible and acceptable for 50 overweight/obese African American adults, with 80% completing the study and 61.5% attending at least 10 sessions.

Participants in the HH intervention reported greater improvements in physical activity and psychosocial well-being compared to those in the waitlist control group, suggesting that mind-body practices can effectively promote health and help reduce cancer disparities in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a faith-based mind-body intervention among African American adults. Mama, SK., Bhuiyan, N., Chaoul, A., et al.[2022]

Mindfulness-based interventions (MBIs) show small but statistically significant benefits for predominantly people of color (POC) populations, with an average of 94.4% POC participants in the analyzed studies, totaling 2,156 individuals.

MBIs were more effective than both active and inactive control groups, particularly in non-clinical populations with higher proportions of POC, suggesting that these interventions may be beneficial for improving well-being in these communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions among people of color: A systematic review and meta-analysis. Sun, S., Goldberg, SB., Loucks, EB., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7753004/

Feasibility and acceptability of a faith-based mind-body ... Harmony & Health was developed as a culturally adapted mind-body intervention to promote physical activity, psychosocial well-being, and quality ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2213422021000421

Fostering spirituality and psychosocial health through mind ... Culturally-tailored, spiritualty-based interventions have shown promising results for improving mental health outcomes, such as stress, depression, and anxiety.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7413187/

A faith-based mind–body intervention to improve ... HH reflects an innovative approach to intertwining spirituality and MB practices to improve physical and psychological health in rural adults, ...

4. researchgate.net researchgate.net/figure/Demographic-characteristics-of-Harmony-Health-participants-by-race-ethnicity_tbl1_343518353

Demographic characteristics of Harmony & Health ... Background This study examined changes spirituality and psychosocial outcomes among African American and rural adults participating in a culturally-adapted mind ...

5. withpower.com withpower.com/trial/phase-psychosocial-6-2023-ee7bc

Faith-based Mind-body Intervention for Psychosocial Health However, studies like 'Harmony & Health' suggest that such interventions are feasible, acceptable, and effective in reducing psychosocial distress in rural ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30476343/

Feasibility and acceptability of a faith-based mind-body ... Harmony & Health (HH) was developed as a culturally adapted mind-body intervention to promote physical activity, psychosocial well-being, and quality of life.

7. researchgate.net researchgate.net/publication/329189409_Feasibility_and_acceptability_of_a_faith-based_mind-body_intervention_among_African_American_adults

Feasibility and acceptability of a faith-based mind-body ... "Harmony & Health" (HH), a culturally adapted MB intervention, was developed in partnership with a faith-based organization to promote physical activity, ...

8. researchgate.net researchgate.net/publication/343518353_A_faith-based_mind-body_intervention_to_improve_psychosocial_well-being_among_rural_adults

(PDF) A faith-based mind–body intervention to improve ... Harmony & Health (HH) was developed as a culturally adapted mind-body intervention to promote physical activity, psychosocial well-being, and quality of life ...