Heartfulness Meditation Cyclic Vomiting Syndrome

Study Overview
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Brief Summary
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Cyclic vomiting syndrome (CVS) is a chronic disorder of gut-brain interaction (DGBI) characterized by episodes of vomiting often triggered by stress. CVS affects 2% of the population and has a disproportionate negative impact on patients and the healthcare system. Although gastrointestinal symptoms are prominent, most patients have comorbid anxiety, depression, high degrees of psychological distress, and other negative cognitive traits that adversely affect health-related quality of life (HRQoL). This is independent of typical measures of severity of CVS and warrants treatment. Recent guidelines recommend a biopsychosocial model of care incorporating techniques like meditation to mitigate stress and improve psychological outcomes in CVS. One potential approach to improve these outcomes is the use of heartfulness (HFN) meditation. Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart. It is offered virtually and is free-of charge ensuring no barriers to broad application in clinical practice. A pilot study incorporating HFN meditation in CVS significantly reduced psychological distress, perceived stress, and improved coping strategies, sleep quality, and HRQoL. Other data also show that HFN meditation improves overall well-being and reduces perceived stress. However, there are significant gaps in our understanding of the mechanism underlying HFN meditation and its effects on patient outcomes.

Official Title
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Heartfulness Meditation: Acute and Long-term Effects on the Endocannabinoid Signaling System and Correlation With Psychological Outcomes in Cyclic Vomiting Syndrome

Conditions
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Cyclic Vomiting Syndrome

Intervention / Treatment
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* Behavioral: Heartfulness meditation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 - 80 years of age Diagnosed with CVS based on Rome criteria Exclusion Criteria: Major psychiatric illness such as schizophrenia, bipolar disease, and major depression or anxiety that is not controlled with medication or requiring inpatient care within the past year History of suicidal attempt/ideation in the past year Cognitive impairment that precludes the ability to meditate Inability to sit for at least 30 minutes Severe cardiopulmonary diseases, malignancy, or renal failure on dialysis Other organic gastrointestinal diseases or systemic diseases including but not limited to inflammatory bowel disease and chronic liver diseases Pregnancy at the time of enrollment BMI < 18 or >35 Regular cannabis use (defined as daily or near-daily cannabis use) and Individuals with significant prior meditation experience (continuous meditation practice for ≥ 3 months within a year prior to the study).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HFN Meditation<br>Subjects will complete guided meditation sessions 3 x a week for six weeks delivered in the app via video, as well as pre- and post-meditation psychological state assessments. | Behavioral: Heartfulness meditation<br>* Heartfulness meditation is a secular, specific, guided meditation technique that includes progressive relaxation with a concentrated focus on the heart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute physiological effects of HFN Meditation on the endocannabinoid signaling system (ECSS) | Conduct a prospective study to elucidate the acute effects of HFN meditation on the ECSS in CVS. We will measure circulating endocannabinoids and related lipids immediately before and after HFN meditation. | 6 weeks | 
| Correlate indices of ECSS with psychological state | Measure stat anxiety with State Trait Anxiety Inventory (STAI) tool | 6 weeks | 
| Correlate indices of ECSS with psychological state | Measure state mood with Profile of Mood States (POMS) tool | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes | Measure psychological distress using Brief Symptom Inventory (BSI) questionnaire | 6 weeks | 
| Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes | Measure sleep quality using Pittsburgh Sleep Quality Index (PSQI) questionnaire | 6 weeks | 
| Long-term effects of HFN Meditation on the ECSS and correlation with psychological outcomes | Measure Health-related quality of life (HRQOL) using Patient-Reported Outcomes Measurement Information System (PROMIS) quality of life questionnaire | 6 weeks |