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

95 Participants Needed

Trial Summary

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.

How does the treatment 'Built environment, Natural environment' differ from other treatments for rumination syndrome?

The treatment 'Built environment, Natural environment' for rumination syndrome is unique because it focuses on modifying the physical surroundings to potentially influence the condition, unlike traditional treatments that often involve behavioral therapies like diaphragmatic breathing. This approach may offer a novel way to address the disorder by altering environmental factors rather than relying solely on patient behavior changes. ^{1 2 3 4 5}

What is the purpose of this trial?

The main goal of this study is to understand how different environments influence both mental responses, like overthinking (rumination), and physical reactions, such as heart rate and blood pressure, after a challenging task.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Review article: the pathophysiology, differential diagnosis and management of rumination syndrome. [2011]

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

Comprehensive Cognitive-Behavioral Interventions Augment Diaphragmatic Breathing for Rumination Syndrome: A Proof-of-Concept Trial. [2022]

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

Duodenal Pathology in Patients with Rumination Syndrome: Duodenal Eosinophilia and Increased Intraepithelial Lymphocytes. [2020]

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

Rumination syndrome: Assessment of vagal tone during and after meals and during diaphragmatic breathing. [2021]

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

Global Prevalence and Impact of Rumination Syndrome. [2022]