Faith-based Mind-body Intervention for Psychosocial Health

Overseen By Scherezade Mama, DRPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Yoga, Pregnancy, Moving, others

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

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

100 Participants Needed

Trial Summary

Do I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial organizers for more details.

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 idea that Faith-based Mind-body Intervention for Psychosocial Health is an effective treatment?

The available research shows that religious involvement and spirituality are generally associated with better health outcomes, such as improved mental health, greater coping skills, and enhanced quality of life. However, the specific effectiveness of Faith-based Mind-body Intervention for Psychosocial Health is not directly addressed in the studies provided. Some studies suggest that spiritual practices can lead to health benefits, but more rigorous research is needed to confirm these effects. Additionally, one study found that stronger spiritual beliefs were linked to poorer clinical outcomes, indicating that the relationship between spirituality and health is complex and not always positive. ^{1 2 3 4 5}

What data supports the effectiveness of the Faith-based Mind-body Intervention treatment for psychosocial health?

Research shows that religious and spiritual practices, like those in the Faith-based Mind-body Intervention, are linked to better health outcomes, including improved mental health and quality of life. These practices can help reduce anxiety and depression, and enhance coping skills, which suggests they may be beneficial for psychosocial health. ^{1 2 3 4 5}

What safety data exists for the faith-based mind-body intervention?

The available research does not explicitly mention safety data for the faith-based mind-body intervention. However, studies like 'Harmony & Health' suggest that such interventions are feasible, acceptable, and effective in reducing psychosocial distress in rural churchgoers. The intervention was culturally adapted and implemented in a church setting, indicating a focus on community-based approaches. While safety is not directly addressed, the positive outcomes and community acceptance imply a level of safety in these interventions. ^{6 7 8 9 10}

Is the Faith-based Mind-body Intervention safe for humans?

The Faith-based Mind-body Intervention, such as the 'Harmony & Health' program, has been found to be feasible and acceptable, suggesting it is generally safe for participants. Mind-body practices, which include relaxation and stress regulation, are well-established in healthcare and are associated with health promotion and self-care principles. ^{6 7 8 9 10}

Is the treatment Harmony & Health Intervention a promising treatment?

Yes, the Harmony & Health Intervention, which is a faith-based mind-body treatment, shows promise. Research indicates that faith-based programs can effectively promote healthy behaviors and improve mental and physical health, especially in minority communities. These interventions often integrate spiritual practices like prayer and meditation, which have been shown to enhance well-being and reduce suffering. ^{1 8 11 12 13}

How is the Faith-based Mind-body Intervention treatment different from other treatments for psychosocial health?

The Faith-based Mind-body Intervention is unique because it integrates spiritual practices like prayer and meditation with health interventions, leveraging religious teachings to promote mental and physical well-being. This approach is particularly tailored to faith communities, making it distinct from standard treatments that may not incorporate spiritual elements. ^{1 8 11 12 13}

What is the purpose of this trial?

To test a program that combines yoga and Christian spirituality (called Harmony \& Health) to learn if it can help participants exercise more.

Research Team

Scherezade Mama, DRPH

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for Black or African American adults who are over 18, have a BMI of at least 25, do less than 90 minutes of exercise per week, and sit for more than 6 hours a day. They must be able to consent, read, speak and write in English. Those who are pregnant or planning to move away from the study areas within six months cannot join.

Inclusion Criteria

Self-identify as Black or African American

I am cleared by a doctor to engage in physical activities.

Self-report doing <90 minutes/week of physical activity

Exclusion Criteria

I sit for less than 6 hours a day.

I am under 18 years old.

Practicing yoga or enrolled in another program targeting physical activity, sitting time, or weight loss

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Harmony & Health intervention or the attention control group, attending sessions twice a week for 8 weeks

8 weeks

16 visits (in-person)

Follow-up

Participants are monitored for retention and adherence, and interviews are conducted to assess acceptance and refine protocols

6 months

Treatment Details

Interventions

• Attention Control
• Fitbit
• Harmony & Health Intervention

Trial Overview The Harmony & Health program is being tested; it's a mix of yoga and Christian spirituality aimed at increasing physical activity among participants. The study will also use Fitbits to monitor activity levels compared with an attention control group.

Participant Groups

Group I: Harmony & Health Intervention (Group 1) Experimental Treatment 2 Interventions

Participants randomized to the Harmony and Health intervention group will attend group-based in-person intervention sessions at FOP or COGIC. on.

Group II: Attention Control (Group 2) Experimental Treatment 2 Interventions

Participants randomized to the attention control condition will participate in in-person group-based health education sessions twice a week for 8 weeks with a trained interventionist and will receive 4 monthly newsletters (20 total contacts).

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

Transformative practices from various religious traditions, such as meditation and yoga, have been shown to enhance psychological and physical well-being, according to several well-designed studies.

Despite the challenges in defining and quantifying 'transformation,' there is a growing need for randomized trials to better understand and validate the health benefits of these spiritual practices in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transformative practices for integrating mind-body-spirit. Luskin, F.[2019]

In a study of 168 participants with chronic medical conditions and a healthy control group, it was found that physical health is positively related to the frequency of attending religious services, suggesting that better health may enable individuals to participate more in their faith communities.

Spiritual beliefs, particularly the belief in a loving higher power and maintaining a positive worldview, are associated with better health outcomes, supporting theories that link psychological and spiritual well-being to physical health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining relationships between physical health and spiritual experience, religious practices, and congregational support in a heterogeneous medical sample. Campbell, JD., Yoon, DP., Johnstone, B.[2021]

The RHIBS Taxonomy is the first comprehensive classification system for religious components in health interventions, developed through a systematic review of 12,337 papers and consensus from 19 international experts, resulting in 82 defined components across 22 categories.

This taxonomy aims to enhance the clarity and consistency of religious health interventions, facilitating better replication, implementation, and evidence synthesis in healthcare research and practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development of the Religious Health Interventions in Behavioural Science (RHIBS) Taxonomy: a scientific classification of religious practices in health. Patel, R., Jong, J., Worthington, EL., et al.[2023]

Patients often view their spiritual health as equally important as their physical health, and addressing spiritual needs can lead to better health outcomes, including improved coping skills and quality of life during illness.

Research indicates that religious involvement and spirituality are linked to positive health effects, such as reduced anxiety and depression, and that supporting patients' spiritual needs can enhance their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Religious involvement, spirituality, and medicine: implications for clinical practice. Mueller, PS., Plevak, DJ., Rummans, TA.[2022]

In a study of 250 patients followed for nine months after hospital admission, 79% reported some form of spiritual belief, but those with stronger beliefs were 2.3 times more likely to have a poor clinical outcome, indicating a potential negative impact of strong spiritual beliefs on recovery.

The research found that stronger spiritual beliefs were a more significant predictor of poor health outcomes than both physical condition and self-reported psychological state at the time of admission, suggesting that spiritual beliefs may influence recovery in unexpected ways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spiritual beliefs on outcome from illness. King, M., Speck, P., Thomas, A.[2019]

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]

The Building a Health Temple (BHT) diabetes self-management education support (DSMES) program is being tested in a cluster-randomized trial involving 360 participants from 18 churches, aiming to improve diabetic outcomes through faith-based interventions.

The primary goal of the study is to assess changes in Hemoglobin A1c (HbA1c) levels, with additional outcomes including body mass index, diabetes distress, and self-care behaviors, highlighting the potential of church settings to enhance diabetes management among Hispanics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a Healthy Temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial. Wilmoth, S., Carrillo, L., Correa, L., et al.[2021]

The Fit Body and Soul intervention, adapted from a successful diabetes prevention program, aims to promote healthy lifestyle changes within African American communities through faith-based initiatives.

This 12-session program incorporates church missions and biblical scripture, leveraging the strong participation of African Americans in faith communities to influence health behaviors and practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fit body and soul: a church-based behavioral lifestyle program for diabetes prevention in African Americans. Dodani, S., Kramer, MK., Williams, L., et al.[2022]

Mind-body medicine (MBM) leverages the connection between the brain, mind, body, and behavior to promote health, focusing on techniques like exercise, relaxation, and nutrition, and is well-established in the US healthcare system.

MBM is effective in addressing chronic lifestyle-related diseases by enhancing individual resilience and reducing stress, and it operates on principles similar to the placebo effect, making it a valuable approach for self-healing and self-care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-healing in health-care: Using the example of mind-body medicine]. Esch, T.[2020]

Faith-based weight management interventions (WMIs) targeting African American women show promise in addressing obesity, but there is a lack of systematic evaluation of these programs, highlighting the need for better assessment criteria.

The review emphasizes the importance of robust research methodologies, including randomization and appropriate intervention design, to ensure the effectiveness and feasibility of faith-based WMIs in church settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review and evaluation of faith-based weight management interventions that target African American women. Timmons, SM.[2022]

A review of 36 studies on faith-based interventions (FBIs) from 2007 to 2017 showed that these studies had moderate and inconsistent integration of faith concepts with health outcomes, indicating a need for better measurement of faith-related factors.

Despite the inconsistent integration of faith, the interventions still led to beneficial outcomes, suggesting that FBIs can be effective, but further research is needed to clarify how faith integration impacts these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of a faith-based integration tool to assess mental and physical health interventions. Saunders, DM., Leak, J., Carver, ME., et al.[2022]

The study developed the '3R' model to create religiously-tailored health messages aimed at improving mammography intentions among Muslim women, based on insights from focus groups and interviews with 25 participants.

The model addresses negative beliefs about health behaviors by reframing, reprioritizing, and reforming these beliefs within a religious context, highlighting both the potential benefits and ethical considerations of using faith-based approaches in health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing religiously-tailored health messages for behavioral change: Introducing the reframe, reprioritize, and reform ("3R") model. Padela, AI., Malik, S., Vu, M., et al.[2018]

A community-based participatory research (CBPR) intervention in 74 African Methodist Episcopal churches involving 1257 members led to significant increases in self-reported moderate- to vigorous-intensity physical activity (MVPA) after 15 months, indicating the intervention's effectiveness in promoting physical health.

The intervention also positively impacted self-reported fruit and vegetable consumption, suggesting that faith-based approaches can successfully encourage healthier lifestyle choices in ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Faith, Activity, and Nutrition program: a randomized controlled trial in African-American churches. Wilcox, S., Parrott, A., Baruth, M., et al.[2022]

References

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

Transformative practices for integrating mind-body-spirit. [2019]

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

Determining relationships between physical health and spiritual experience, religious practices, and congregational support in a heterogeneous medical sample. [2021]

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

The development of the Religious Health Interventions in Behavioural Science (RHIBS) Taxonomy: a scientific classification of religious practices in health. [2023]

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

Religious involvement, spirituality, and medicine: implications for clinical practice. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The effect of spiritual beliefs on outcome from illness. [2019]

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

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

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

Building a Healthy Temple diabetes self-management education support program in Hispanic faith community settings: A cluster randomized controlled trial. [2021]

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

Fit body and soul: a church-based behavioral lifestyle program for diabetes prevention in African Americans. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Self-healing in health-care: Using the example of mind-body medicine]. [2020]

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

Review and evaluation of faith-based weight management interventions that target African American women. [2022]

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

Application of a faith-based integration tool to assess mental and physical health interventions. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Developing religiously-tailored health messages for behavioral change: Introducing the reframe, reprioritize, and reform ("3R") model. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

The Faith, Activity, and Nutrition program: a randomized controlled trial in African-American churches. [2022]