Environment for Rumination Syndrome

(RUMI Trial)

Overseen By Susan S Rodriguez, Bachelor of Arts

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Must not be taking: Cardiovascular medications

Disqualifiers: Cardiovascular disease, Pregnancy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different environments affect mental and physical responses after a challenging task. Participants will spend time in either a built (man-made) environment or a natural setting. Researchers aim to determine how these settings influence overthinking and changes in heart rate and blood pressure. The trial seeks individuals who frequently overthink after stressful situations but do not have heart problems or take medications affecting their heart. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of environments on stress responses.

Will I have to stop taking my current medications?

If you are taking medications that affect heart function, you may not be eligible for the trial. The protocol does not specify if you need to stop other medications.

What prior data suggests that these environments are safe for participants?

Research has shown that spending time in nature can help reduce anxiety and overthinking. One study found that a 90-minute walk in nature lowered both self-reported overthinking and certain brain activities related to it. This suggests that being in nature is not only safe but also beneficial for mental health.

In contrast, urban areas have been linked to higher rates of depression, especially in poorer neighborhoods. However, no specific evidence shows that short-term exposure to urban settings is harmful during studies like this one.

Overall, both natural and urban environments are common and generally considered safe for participants in this type of research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring the impact of different environments on rumination syndrome because it offers a unique, non-pharmacological approach to treatment. Unlike traditional treatments that often focus on dietary changes, medication, or therapy, this study investigates how physical surroundings—specifically built versus natural environments—can influence the condition. The hope is to find out whether exposure to natural settings can provide therapeutic benefits, potentially leading to innovative strategies that complement or even enhance current care options for patients with rumination syndrome.

What evidence suggests that this trial's environments could be effective for rumination syndrome?

This trial will compare the effects of different environments on rumination syndrome. Participants will be assigned to either a built or natural environment. Research has shown that spending time in nature can reduce repetitive negative thinking, known as rumination. One study found that people who took a 90-minute walk in nature reported less negative thinking and showed changes in brain activity linked to this pattern. Another study found that even watching nature videos can lower negative feelings and boost mood. There is less direct evidence about how built environments, like cities, affect rumination. However, some studies suggest that the design of these spaces can impact health in various ways. Overall, natural settings appear more effective at reducing rumination than built environments. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 without cardiovascular diseases, not pregnant, and not on meds that affect heart function. It's designed to see how different settings impact mental and physical reactions after a tough task.

Exclusion Criteria

I have a history of heart disease or conditions.

Individuals who are pregnant

I am on medication that could affect my heart.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Session

Participants engage in a 2.5-hour session including environment immersion, baseline measurement, challenging task, and post-task surveys

2.5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the session

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Built environment
• Natural environment

Trial Overview The study tests the effects of built (like cities) versus natural environments on the mind's tendency to overthink and body responses such as heart rate and blood pressure following a challenging task.

How Is the Trial Designed?

Group I: Natural environment Experimental Treatment 1 Intervention

Participants will complete the study session in a natural environment.

Group II: Built environment assignment Experimental Treatment 1 Intervention

Participants will complete the study session in a built environment

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

Published Research Related to This Trial

Diaphragmatic breathing (DiaB) significantly reduced the number of rumination episodes in patients with rumination syndrome (RS), indicating its efficacy as a treatment method, despite not being linked to changes in vagal tone.

Patients with RS did not show decreased vagal tone during meals compared to healthy volunteers, suggesting that the pathophysiology of RS may not be directly related to vagal tone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rumination syndrome: Assessment of vagal tone during and after meals and during diaphragmatic breathing. Hoshikawa, Y., Fitzke, H., Sweis, R., et al.[2021]

Rumination syndrome, characterized by the involuntary regurgitation of food, can affect individuals of all ages and is diagnosed using criteria established by the Rome III consensus, with additional diagnostic support from high-resolution manometry.

While the exact cause of rumination syndrome is not fully understood, it involves a rise in stomach pressure due to abdominal muscle contractions, and the primary treatment is behavioral therapy, although more controlled trials are needed to confirm the effectiveness of various proposed treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review article: the pathophysiology, differential diagnosis and management of rumination syndrome. Tack, J., Blondeau, K., Boecxstaens, V., et al.[2011]

The global prevalence of rumination syndrome is 3.1%, with the highest rates found in Brazil (5.5%) and the lowest in Singapore (1.7%), indicating it may be more common than previously thought.

Factors such as depression, anxiety, and being female are significantly associated with rumination syndrome, and individuals with multiple gastrointestinal disorders are at a much higher risk, suggesting a need for increased awareness and diagnosis in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Global Prevalence and Impact of Rumination Syndrome. Josefsson, A., Hreinsson, JP., Simrén, M., et al.[2022]

Patients with rumination syndrome show a significant increase in duodenal eosinophil counts compared to controls, indicating a potential histological change associated with the disorder.

In addition to eosinophilia, patients with rumination syndrome also have higher intraepithelial lymphocyte counts, suggesting subtle duodenal pathology that may contribute to their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duodenal Pathology in Patients with Rumination Syndrome: Duodenal Eosinophilia and Increased Intraepithelial Lymphocytes. Halland, M., Talley, NJ., Jones, M., et al.[2020]

A comprehensive Cognitive-Behavioral Therapy (CBT) protocol for treating Rumination Syndrome (RS) showed promising results, with participants experiencing large reductions in regurgitations after 5-8 sessions, indicating its efficacy.

The addition of CBT strategies beyond diaphragmatic breathing further enhanced symptom reduction, and treatment gains were maintained for most participants at a 3-month follow-up, suggesting the approach is both feasible and acceptable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive Cognitive-Behavioral Interventions Augment Diaphragmatic Breathing for Rumination Syndrome: A Proof-of-Concept Trial. Murray, HB., Zhang, F., Call, CC., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4507237/

Nature experience reduces rumination and subgenual ... We show in healthy participants that a brief nature experience, a 90-min walk in a natural setting, decreases both self-reported rumination and neural activity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9332585/

Nature-Based Meditation, Rumination and Mental Wellbeing The study results showed improvements for all groups on self-report measures at 3-month follow-up, including reduced depressive symptoms, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0013935122014086

Exploring the role of exposure to green and blue spaces in ... This review aims to explore whether exposure to green and blue spaces reduces the risk of anxiety and depression among young people aged 14–24 years living in ...

4. gastrojournal.org gastrojournal.org/article/S0016-5085(21)03730-6/fulltext

Global Prevalence and Impact of Rumination Syndrome In the largest epidemiologic study to date on rumination syndrome, we report the global prevalence (3.1%), factors associated with rumination ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/pdf/10.1111/hsc.13081

The health effect of perceived built environment on ... The results confirmed the significant association between perceived built environment and health outcomes among the aged sample. That is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8125471/

Associations between Nature Exposure and Health Exposure to natural environments has been linked with decreases in anxiety and rumination, which are associated with negative mental health outcomes, such as ...

7. cdc.gov cdc.gov/pcd/issues/2021/20_0605.htm

Association of the Neighborhood Built Environment With ... The built environment was associated with prevalence and risk of depression, and associations were stronger in high-poverty neighborhoods.

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553922/

Health Outcomes Related to Built Environments - NCBI - NIH This chapter is dedicated to understanding the conceptual differences between healthy and unhealthy built environments.

9. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1584466/full

A systematic review on the associations between built ... This comprehensive systematic review synthesizes research on the association between BE elements and the mental health (MH) of the older adult population.