Harmony & Health Program for Mental Health

Overseen By Scherezade Mama, DRPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Physically active, Not sedentary, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

54 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.

What data supports the effectiveness of the Harmony & Health Program for Mental Health treatment?

Research shows that yoga, a component of the Harmony & Health Program, can help manage anxiety and improve mood and mental health. Studies also suggest that integrated mind-body wellness programs, which include yoga, are effective in enhancing mental well-being. ^{1 2 3 4 5}

Is the Harmony & Health Program for Mental Health safe for humans?

Research on yoga, which is a component of the Harmony & Health Program, shows that it is generally safe for humans. A review of 94 studies with over 8,000 participants found no significant differences in serious or nonserious adverse events when comparing yoga to usual care or exercise. ^{6 7 8 9 10}

How is the Harmony & Health Program for Mental Health different from other treatments for mental health?

The Harmony & Health Program is unique because it combines yoga and Christian spirituality, offering a holistic mind-body approach that integrates physical exercises, breathing, meditation, and spiritual elements to improve mental health and well-being. ^{1 5 7 8 11}

What is the purpose of this trial?

To test the feasibility and acceptability of a program that combines yoga practices and Christian spirituality (called Harmony \& Health) amongst insufficiently active Black adults.

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 years old, living in Northeast Texas who are not very active (less than 75 minutes of exercise per week), tend to sit a lot (6+ hours a day), and have a BMI of at least 25. They must be able to read and write in English, pass a health readiness survey or get doctor's approval, and can't plan on moving or becoming pregnant soon.

Inclusion Criteria

Able to pass the Physical Activity Readiness Questionnaire (PARQ) or provide physician's clearance to participate

Primary residence in the Northeast Texas area (Public Health Region 4/5N)

Self-identify as Black or African American

Exclusion Criteria

I have no health conditions that prevent me from exercising on my own.

BMI <25.0 kg/m2

Do not self-identify as Black or African American

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Harmony & Health program or health education sessions for 9 weeks

9 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in sitting time and LPA, and interviews are conducted to assess program satisfaction

15 weeks

Post-intervention and follow-up assessments

Treatment Details

Interventions

• Harmony & Health

Trial Overview The study is looking into the Harmony & Health program which combines yoga with Christian spirituality to see if it's something people will do and like. It targets Black adults who don't move much to help improve their mental wellbeing.

Participant Groups

Group I: Health and Harmony Experimental Treatment 2 Interventions

Participants will take part in a program combining yoga practices and Christian spirituality.

Group II: Health Education (Control) Experimental Treatment 2 Interventions

Participants will take part in a series of health education sessions.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Duncan Family Institute (DFI) Seed Funding Program

Collaborator

Trials

1

Recruited

50+

Findings from Research

In a study involving adults in a locked psychiatric unit, participating in Hatha yoga three times a week led to a significant reduction in anxiety symptoms, with improvements noted after just two classes.

Patients reported yoga and meditation as effective new coping strategies upon discharge, indicating that these practices can provide sustained benefits in managing anxiety, even though there was no change in sleep hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

East meets west in psychiatry: Yoga as an adjunct therapy for management of anxiety. Bukar, NK., Eberhardt, LM., Davidson, J.[2020]

A single-session group yoga intervention for 104 patients in a partial hospital program led to significant short-term improvements in mood, as measured by changes in positive and negative affect.

While the yoga participants did not show greater reductions in anxiety or depression symptoms compared to those who did not attend the session, they reported higher satisfaction with the quality of care received.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a brief adjunctive yoga intervention for short-term mood and psychiatric symptom change during partial hospitalization. Chad-Friedman, S., Forgeard, M., McHugh, K., et al.[2019]

The study will evaluate the effectiveness of the Yoga of Stress Resilience program, which combines yoga and psychotherapy, in improving mental health and reducing burnout among adults experiencing anxiety and burnout.

Using a before-after interventional trial design, the study will assess various mental health outcomes, including anxiety, depression, and functional impairment, to determine the program's impact over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. Alvarez, E., Sutton, A., Barton, B., et al.[2021]

An 8-week mindfulness intervention for healthcare professionals led to sustained improvements in burnout and mindfulness skills, with benefits maintained at a 3-month follow-up for 35 participants.

The study found that two specific mindfulness skills, acting with awareness and nonjudging of inner experience, were negatively correlated with distress and impairment, suggesting they may help protect against stress and burnout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of Effects and Correlates of Changes Following Mindfulness for Interdisciplinary Health Care Professional Students. Braun, SE., Mladen, SN., Luberto, CM., et al.[2022]

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]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

A scoping review of eight studies found that yoga programs in U.S. medical schools positively impact medical students' psychological well-being and stress levels, suggesting that yoga can be an effective tool for resilience during their training.

Yoga is offered in medical schools through recreational, research, and educational models, indicating a growing recognition of its benefits in enhancing both student well-being and medical education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Approaches to Yoga in U.S. Medical Schools: Scoping Review of the Literature. Horiuchi, S., Flusberg, Y., Peterson, CT., et al.[2022]

A systematic review of various studies indicates that yoga can significantly improve mental health outcomes, such as reducing anxiety and depression, particularly in specific populations like veterans and adolescents exposed to trauma.

Yoga interventions have shown positive effects on physical health, including improved quality of life, reduced distress, and better management of conditions like arthritis and heart disease, suggesting its efficacy as a complementary therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

2013 SYR Accepted Poster Abstracts. [2018]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

A significant portion of young adults (43.9%) reported experiencing adverse childhood events, which were linked to higher stress levels, highlighting a critical public health concern.

Despite the challenges faced, 12.7% of the young adults practiced yoga for at least 30 minutes a week, with those exposed to adverse events practicing yoga at equal or greater rates than their peers, suggesting yoga could be a beneficial coping strategy for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. Neumark-Sztainer, D., Wall, MM., Choi, J., et al.[2020]

The study developed a spiritually-based holistic health measure called the QE Health Scale (QEHS), which showed high reliability (Cronbach's alpha = 0.92) and validity in a sample of 233 participants with chronic physical conditions.

The QEHS correlated significantly with established measures of health, indicating its potential effectiveness in assessing holistic health in individuals with chronic conditions, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A spiritually-based measure of holistic health for those with disabilities: development, preliminary reliability and validity assessment. Faull, K., Hills, MD.[2019]

References

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

East meets west in psychiatry: Yoga as an adjunct therapy for management of anxiety. [2020]

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

Effectiveness of a brief adjunctive yoga intervention for short-term mood and psychiatric symptom change during partial hospitalization. [2019]

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

Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. [2021]

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

Maintenance of Effects and Correlates of Changes Following Mindfulness for Interdisciplinary Health Care Professional Students. [2022]

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

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

6. England pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. [2022]

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

Current Approaches to Yoga in U.S. Medical Schools: Scoping Review of the Literature. [2022]

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

2013 SYR Accepted Poster Abstracts. [2018]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

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

Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. [2020]

11. England pubmed.ncbi.nlm.nih.gov

A spiritually-based measure of holistic health for those with disabilities: development, preliminary reliability and validity assessment. [2019]