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

Trial Summary

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 data supports the effectiveness of the treatment Harmony & Health program, Culturally Adapted Mindbody Intervention for mental health in Black adults?

Research shows that the Harmony & Health program, a culturally adapted mind-body intervention, is effective in improving physical activity and psychosocial well-being among African American adults. Additionally, mind-body approaches, like those used in the program, have been found to reduce stress, depressive symptoms, and anxiety, making them a promising option for improving mental health in underserved populations. ^{1 2 3 4 5}

Is the Harmony & Health program safe for Black adults?

The Harmony & Health program, a mind-body intervention, has been found to be feasible and acceptable among African American adults, with no reported safety concerns in the studies reviewed. Participants in these studies experienced improvements in physical activity and psychosocial well-being, suggesting it is generally safe for use in humans. ^{3 4 5 6 7}

How is the Harmony & Health program treatment different from other treatments for mental health in Black adults?

The Harmony & Health program is unique because it is a culturally adapted mind-body intervention that combines physical activity with spiritual and psychosocial well-being, specifically designed for Black adults. It leverages existing community structures, like churches, to make mental health support more accessible and acceptable to underserved populations. ^{1 3 4 5 6}

What is the purpose of this trial?

This community-based study will assess the efficacy of a culturally adapted, yoga-based intervention to reduce sitting time, increase physical activity, and improve psychosocial wellbeing among insufficiently active Black adults in the Houston area.

Research Team

Scherezade Mama, DRPH

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Fostering spirituality and psychosocial health through mind-body practices in underserved populations. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

A qualitative investigation to inform yoga intervention recruitment practices for racial/ethnic minority adolescents in outpatient mental health treatment. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a faith-based mind-body intervention among African American adults. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A faith-based mind-body intervention to improve psychosocial well-being among rural adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mind-Body Approaches to Treating Mental Health Symptoms Among Disadvantaged Populations: A Comprehensive Review. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evidence and Feasibility of Implementing an Integrated Wellness Program in Northeast Georgia. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based interventions among people of color: A systematic review and meta-analysis. [2023]