54 Participants Needed

Harmony & Health Program for Mental Health

SM
Overseen ByScherezade Mama, DRPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.678910

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.157811

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

SM

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
See 5 more

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
See 8 more

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
2Treatment groups
Experimental Treatment
Group I: Health and HarmonyExperimental Treatment2 Interventions
Participants will take part in a program combining yoga practices and Christian spirituality.
Group II: Health Education (Control)Experimental Treatment2 Interventions
Participants will take part in a series of health education sessions.

Find a Clinic Near You

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.
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.
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.
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]

References

East meets west in psychiatry: Yoga as an adjunct therapy for management of anxiety. [2020]
Effectiveness of a brief adjunctive yoga intervention for short-term mood and psychiatric symptom change during partial hospitalization. [2019]
Evaluating a group-based Yoga of Stress Resilience programme: a pragmatic before-after interventional study protocol. [2021]
Maintenance of Effects and Correlates of Changes Following Mindfulness for Interdisciplinary Health Care Professional Students. [2022]
Evidence and Feasibility of Implementing an Integrated Wellness Program in Northeast Georgia. [2018]
A large-scale survey of adverse events experienced in yoga classes. [2022]
Current Approaches to Yoga in U.S. Medical Schools: Scoping Review of the Literature. [2022]
2013 SYR Accepted Poster Abstracts. [2018]
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]
10.United Statespubmed.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]
A spiritually-based measure of holistic health for those with disabilities: development, preliminary reliability and validity assessment. [2019]
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