An integrative healthcare model with heartfulness meditation and care coordination improves outcomes in cyclic vomiting syndrome

Abstract

Background:

Cyclic vomiting syndrome (CVS) is associated with psychosocial comorbidity and often triggered by stress. Since the current disease-centered care model does not address psychosocial factors, we hypothesized that holistic, patient-centered care integrating meditation and addressing psychosocial needs through a care coordinator will improve healthcare outcomes in CVS.

Methods:

We conducted a prospective randomized controlled trial: 49 patients with CVS (mean age: 34 ± 14 years; 81% female) were randomized to conventional health care (controls) or Integrative Health care (IHC) (27: controls, 22: IHC). The IHC group was assigned a care coordinator and received meditation with a certified instructor. Outcomes including psychological distress, coping strategies to manage chronic stress, cognitive symptom management, and Health-Related Quality of Life (HRQoL) were measured.

Key Results:

In intention-to-treat analyses, patients receiving IHC showed significant improvement in multiple domains of coping including positive reframing, planning, and reduction in self-blame (p values ≤0.05), and physical HRQoL (p = 0.03) at 6 months. They also leaned toward spirituality/religion as a coping measure (p ≤ 0.02 at 3 and 6 months). Subgroup analysis of compliant patients showed additional benefit with significant reduction in psychological distress (p = 0.04), improvement in sleep quality (p = 0.03), reduction in stress levels (0.02), improvement in physical HRQoL (0.04), and further improvement in other domains of coping (p < 0.05).

Conclusions and Inferences:

An IHC model incorporating meditation and care co-ordination improves patient outcomes in CVS and is a useful adjunct to standard treatment. Studies to determine the independent effects of meditation and care co-ordination are warranted.

1 |. INTRODUCTION

CVS is a chronic functional disorder of gut-brain interaction (DGBI) that is characterized by episodic nausea and vomiting and is often triggered by stress.^1–4 The prevalence of CVS in adults is about 2% based on a population-based study in the United States, while other studies have shown a 10% prevalence among patients seen in a tertiary gastroenterology clinic.^5,6 Though CVS is a GI disorder, patients with CVS have multiple comorbid psychological disorders such as anxiety, depression, and panic. In contrast to these disorders which are diagnosed by medical providers, psychological distress is a useful construct to measure as it offers the advantage of being reported directly by patients and is more valid as a useful outcome measure. Of relevance, a previous study by Taranukha et al. showed that 42% of patients with CVS have high degrees of psychological distress, which can have a negative impact on outcomes in CVS, similar to other DGBIs⁷ Hence, in addition to standard pharmacological treatment for control of GI symptoms, it is likely that stress management will improve the overall health of patients with CVS.

Complementary and alternative medicine (CAM) is rapidly emerging as an adjunctive therapy for various disorders. About 42% of patients with a gastrointestinal disorder endorsed using CAM, and >80% found that it improved symptoms.⁸ One such strategy involving mindfulness-based meditation is effective in various stress-related disorders and can reduce psychological distress, anxiety, and depression.^9–11 This form of therapy has also been studied in DGBIs such as irritable bowel syndrome (IBS) where meditators had a significant improvement in quality of life and reduction in symptom severity and psychological distress.^12,13 Despite data demonstrating the efficacy of meditation in other stress-related disorders, there are no studies in CVS. Prior to this study, we surveyed CVS patients seen in our clinic on the use of complementary therapies such as meditation, and of 66 respondents, 52 (79%) felt that meditation would reduce stress, and 91% stated that they would be willing to practice meditation consistently if it were offered to them.

Currently, therapy in CVS is often acute and episodic; psychosocial determinants of health in modulation of symptoms are largely ignored due to constraints related to time and resources. Integrative health care, which is broadly defined as a model of care that integrates Western Medicine with complementary therapies and focuses on the patient as a whole, can improve healthcare outcomes in CVS by addressing various psychosocial barriers to health. However, there are limited data studying these models of care in gastrointestinal disorders. Though the different aspects of integrative health care can vary widely, it is this very flexibility that can help address aspects of different disorders and tailor the model based on the needs of a specific patient population. Given the high degrees of psychosocial problems and psychological distress in CVS and the benefits of meditation in mitigating this, we hypothesized that an integrative healthcare model incorporating meditation to reduce psychological distress and adding a care coordinator to identify and address unmet psychosocial barriers to health will significantly improve the overall health of this population. The aim of our study was to determine the effects of an integrative healthcare model using heartfulness meditation and a care coordinator on psychological outcomes, quality of life, and healthcare utilization in patients with CVS and also demonstrate feasibility. This novel study aligns both community partners and healthcare professionals to redesign the healthcare delivery system. (Figure 1) Our model specifically addresses psychosocial determinates of health which contribute to severity of DGBIs. Both clinical and translational data clearly support the implementation of such programs to improve the overall health of a population.

FIGURE 1.

Integrative HealthCare model. Based on the Chronic Care model proposed by Wagner et al.1999. The meditation logo was reproduced with permission from the Heartfulness Institute. CVSA, Cyclic Vomiting Syndrome Association; REDCap Research Electronic Data Capture

2 |. METHODS

2.1 |. Model of care

We conducted a prospective, clinical intervention trial in which patients were randomized to either standard care or the IHC model. In addition to standard care, the IHC model addressed psychosocial well-being and coping skills, and chronic disease management. This was achieved with meditation practice and a care coordinator. Approval was obtained from the Institutional Review Board (Medical College of Wisconsin) prior to the study, and the trial was registered with Clinicaltrials.gov (NCT04329637).

2.2 |. Standard of medical care

All patients who are seen in the specialized CVS clinic are assessed and treatment is based on standard guidelines. Those who have moderate-severe disease are offered prophylactic treatment for CVS, which includes the use of amitriptyline, the current first-line treatment for CVS. Other options include topiramate or aprepitant, and the final choice of medication is made based on individual patient characteristics, preference, and cost. All patients are also offered abortive medications to terminate episodes: these include the use of antiemetics such as ondansetron, triptans, and sedatives such as diphenhydramine. If patients have underlying comorbid conditions such as anxiety or depression, they are advised to see a psychiatrist/psychologist or their primary care physician. They are also counseled about adopting lifestyle measures such as sleep hygiene and gentle, graded exercise to combat stress. All subjects were able to email the treating team via “MyChart,” which is an online portal available to all patients or call the nursing line with questions pertaining to their health. Any changes in medications were managed by the treatment team which consisted of nurses and nurse practitioners who are specifically trained and are familiar with the management of patients with CVS. There were no differences in the standard management of patients in either group.

2.3 |. Heartfulness meditation

All subjects received guided meditation, referred to as Heartfulness meditation, through certified trainers from the Heartfulness Institute (HI). HI is a non-profit organization that offers instruction and lifetime support in meditation practices free-of-charge. The heart-based meditation is based on an ancient yogic technique called “Pranahuti” which involves transmission of subtle cosmic or divine energy. Heart-based meditation is focused on resting awareness in the heart and is distinct from commonly employed meditation practices like mindfulness. More details on heartfulness meditation and differences to mindfulness-based meditation can be found in File S1.

There were a total of five HI Instructors who worked with subjects. All instructors were familiar with the study protocol and followed standard procedures. While most subjects worked with a single instructor during the course of the study, some subjects worked with at least two instructors, due to availability and logistics. All subjects were also given access to a free meditation app designed by HI. Subjects were encouraged to use this daily or as often as possible. In addition to receiving instruction on medication practices and one-on-one sessions by the HI instructors, subjects in the IHC group were also directed to the Heartfulness website (heart-fulness.org). This website provided teaching material and additional resources, which helped them meditate at home on their own. The subjects clarified any doubts with the instructors, or the care coordinator who was familiar with the meditation practice. The meditation practice itself consisted of a period of relaxation, followed by meditation and cleaning (rejuvenation).

Subjects were encouraged to contact the instructor every week for one-on-one guided sessions. Subjects were encouraged to attend three online introductory classes (masterclasses). Subjects were instructed to maintain a diary and note down the frequency of their meditation and personal reflections for their own benefit. We did not mandate these entries to be available to us. Compliance with meditation was made based on a global assessment by the care coordinator with input from the HFN instructors.

2.4 |. Care coordinator

The primary role of the care coordinator was to use motivational interviewing techniques to identify patient goals, preferences, and barriers to self-management and address psychosocial and environmental issues that determine health, which are not currently addressed in the traditional healthcare model. An experienced care coordinator who demonstrated skills in engaging patients across different socioeconomic and cultural backgrounds was employed for this project. The care coordinator performed an initial risk assessment after study enrollment to identify psychosocial and environmental barriers to health. Direct patient interview, which lasted up to 45 minutes, and electronic medical health records were utilized to capture risk factors for poor health. The care coordinator worked with subjects in the IHC model and facilitated access to resources within the traditional healthcare system and in the community, based on individual patient needs. This included but was not limited to medication assistance, transportation, and facilitating access to mental health services. Follow-up with subjects was done at minimum every month during the course of the study and more frequently if needed.

Compliance was assessed globally by the care coordinator at the end of the study. Mandatory components of compliance included 1. Responding to the care coordinator via email or telephone regularly 2. Communication and contacting the HI instructors for meditation sessions and/or using the app and other meditation resources regularly. This global subjective assessment was made by the care coordinator independently without any input from the principal investigator to mitigate bias. However, input from the HI instructors was incorporated by the care coordinator who encouraged patients to comply with the meditation practice.

2.5 |. Participants

All patients >18 years of age who were diagnosed with CVS based on Rome criteria in the specialized CVS clinic were eligible to participate.⁴ Exclusion criteria included severe cognitive impairment, active mental health problems such as suicidal ideation, severe anxiety, or depression requiring inpatient care, or an inability to sit for at least 20 minutes. Subjects with severe cardiopulmonary diseases, malignancy, liver cirrhosis, renal failure on dialysis, or those who were pregnant at the time of enrollment were excluded.

2.6 |. Protocol

Patients were prospectively randomized using a computer-generated algorithm to either the integrative health care model (IHC model) or usual care (control) group after signing informed consent. Demographics, clinical characteristics, and outcomes of interest were measured at baseline before the intervention, and at 3 and 6 months, post-randomization. The intervention period for all subjects was 6 months.

2.7 |. Outcomes

Measures of patient mood and global psychological distress were assessed using the Brief Symptom Inventory (BSI), which was the primary outcome of the study.¹⁴ The Hospital Anxiety and Depression Score (HADS) was used to screen for anxiety and depression.¹⁵ The potential roles of depression, catastrophizing, anxiety/pain-related fear, and social support were assessed using Pain Catastrophizing Scale,¹⁶ Pain Anxiety Symptom Scale,¹⁷ Perceived Stress Scale,¹⁸ the Self-efficacy Scale,¹⁹ and the Multidimensional Scale of Perceived Social Support.²⁰ Affective states and regulation of emotion were assessed using the Positive Affect-Negative Affect Schedule (PANAS)²¹ and Emotion Regulation Questionnaire.²² Coping skills were measured with the validated short version of the COPE questionnaire.²³ Quality of sleep was assessed with the Pittsburgh Sleep Quality Index (PSQI).²⁴ HRQoL was measured with the NIH PROMIS Global Health Short Forms (version 1).²⁵ Healthcare utilization including the number of emergency department (ED) visits and hospitalizations during the course of the study were recorded, though this study was not powered to assess these outcomes. The care coordinator had detailed notes documented in the electronic medical records and HI instructors kept a tally of individual meditation sessions by subjects. Compliance was defined globally by the care coordinator based on patient adherence to the protocol which included meditation sessions, willingness to return phone calls, and actively engage in the process.

2.8 |. Statistical analysis

A sample size estimate was done using preliminary data on BSI T-scores in our patient population from previous studies showing a mean of 61 with standard deviation of 12 among CVS patients. ⁷Twenty-five subjects per group were needed, using a power of 80% and a two-sided 5% significance, to detect a 10-point decrease in the primary outcome of interest, the BSI global severity T-score.

Baseline characteristics were compared between the groups using chi-square test and t test for categorical and continuous variables, respectively. Continuous outcomes were analyzed using an ANCOVA approach adjusting for baseline values. Count outcomes such as number of ED visits and hospitalizations were analyzed using negative binomial regression. For each continuous outcome, a repeated measures model was used adjusting for baseline score, group type, and visits at 3 and 6 months. A post hoc subgroup analysis was performed that included only patients who were compliant with the IHC model of care. Statistical significance (i.e. alpha level) was set at 0.05 and all p values were two-sided.

3 |. RESULTS

3.1 |. Study population

A total of 49 subjects with CVS were included in the intention-to-treat analysis. The flow diagram of study procedures and recruitment is shown in Figure 2. Demographics and clinical characteristics of study participants are shown in Table 1. Patients in the IHC group tended to be sicker with a mean of 3.0 ± 4.6 vs. 1.2 ± 1.8 ED visits in the 3 months prior to the study, though this was not significant (p = 0.065, Table 1). There were no differences in the use of prophylactic or abortive medications for CVS between the two groups. There were 5/22 (22.7%) patients (IHC group) and 9/27(33.3) in the control group who were actively seeing a mental health professional during the course of the study. While there were more subjects in the control group who were seeking mental health care, this was not statistically significant (p = 0.6).

FIGURE 2.

Flow diagram of recruitment and study participation

TABLE 1.

Demographics and clinical characteristics of patients with CVS

Variable	Total N = 49	Control subjects (Usual care) N = 27	IHC model subjects N = 22
Age mean (SD)	34.0 (14.2)	36.2 (13.1)	31.2 (15.3)
Gender
Female	40 (81.6%)	20 (74.1%)	20 (90.9%)
Race
Caucasian	42 (86%)	21 (78%)	21 (95.4%)
African-American	3 (6%)	3 (11%)	0 (0)
Hispanic	1 (2%)	1 (3.7%)	0 (0)
Asian	1 (2%)	0 (0)	1 (4.5%)
Not disclosed/refused	2 (4%)	2 (7.4%)	0 (0)
BMI mean (SD)	29.6(7.7)	31.3(7.6)	27.8(7.6)
Duration of CVS (in years)
Mean (SD)	12.0 (8.1)	12.1 (9.5)	12.0 (6.0)
History of migraine
Yes	33 (70.2%)	17 (68.0%)	16 (72.7%)
Missing	2	2	0
Anxiety
Yes	35 (74.5%)	19 (76.0%)	16 (72.7%)
Missing	2	2	0
Depression
Yes	29 (61.7%)	14 (56.0%)	15 (68.2%)
Missing	2	2	0
Bipolar disease	5 (10.6%)	3 (12.0%)	2 (9.1%)
Irritable bowel syndrome	13 (27.7%)	9 (36.0%)	4 (18.2%)
Fibromyalgia	3 (6.4%)	1 (4.0%)	2 (9.1%)
Current cannabis use
Yes	15 (33.3%)	9 (37.5%)	6 (28.6%)
Missing	4	3	1
Current smoking
Yes	18 (38.3%)	10 (40.0%)	8 (36.4%)
Missing	2	2	0
Alcohol abuse	0	0	0
Prophylactic therapy
TCA use	28 (57%)	16 (59%)	12 (56%)
Topiramate	11 (22%)	6 (22%)	5 (23%)
Aprepitant	15 (31%)	9 (33%)	6 (27%)
Mitochondrial supplements (CoQ 10, L-carnitine, Vitamin B2)	23 (47%)	14 (52%)	9 (41%)
Abortive medications
Ondansetron	38 (77.5%)	21 (78%)	17 (77%)
No of CVS in the 3-month interval prior to the study mean (SD)	3.0 (0.0,15.0)	2.0 (0,15.0)	4.0 (1.0,15.0)
No of ED visits in the 3-month interval prior to the study	2.0 (3.4)	1.2 (1.8)	3.0 (4.6)
No of hospitalizations in the 3-month interval prior to the study	0.6 (1.4)	0.5 (0.9)	0.7(1.8)

3.2 |. Effects on psychological distress, domains of coping, and health-related quality of life

There were no differences in the BSI scores between the control and intervention group at 3 and 6 months, on an intent-to-treat analysis. There was a statistically significant improvement in the intervention group compared to the control group (adjusting for baseline), in multiple domains of coping including planning (p = 0.019), reduction in self-blame (p = 0.046), positive reframing (p = 0.021), and use of spirituality/religion as a means of coping at both 3 and 6 months (p = 0.003 and 0.02) as shown in Figure 3. There was also a reduction in perceived stress at 6 months [−6.46 (−13.07, 0.15), p = 0.05], though this was not significant. There was a significant improvement in physical HRQoL at 6 months in the IHC group [5.04,(0.93,9.15), p = 0.01]. There were no significant differences in other outcomes such as mental HRQoL, and other domains of coping. While there was a trend toward improved overall sleep quality (PSQI scores), this was not statistically significant. Summary of outcomes estimated effects and p values are shown in supplemental information (Table S1). Post hoc analysis, adjusting for instructor effects, is shown in supplemental information (Table S2). The IHC group showed additional improvement with acceptance (domain of coping) being statistically significant at 6 months [1.10 (−0.02, 2.22), p = 0.04]. The use of spirituality/religion as a means of coping remained significant after 3 months [1.34 (0.32, 2.36), p = 0.012] but not at 6 months [1.18 (−0.10, 2.47), p = 0.06]. There were no differences in other variables when adjusting for instructor effects.

FIGURE 3.

Changes in various domains of coping in CVS in the IHC group and controls

3.3 |. Effects on healthcare utilization

There was no difference between the two groups in change from baseline in the number of episodes of CVS or ED visits at 3 and 6 months. There was an increased risk of hospitalizations in the IHC group at 6 months [risk ratio 1.3 (1.03, 1.61) p = 0.026].

3.4 |. Effects of the IHC model in compliant patients

Among the 14 (64%) compliant patients in the IHC group, there were significantly lower values for psychological distress compared to the control group, adjusting for baseline, as measured by the BSI at 3 months [−5.73 (−11.23, −0.22), p = 0.04] but not at 6 months. There was also better sleep quality/reduction in PSQI scores [−2.17 (−4.10, −0.24), p = 0.03] at 6 months in the IHC group. Significant improvement in multiple domains of coping including acceptance [1.21 (−0.00, 2.42), p = 0.050], planning [1.53 (0.11, 2.94), p = 0.036], positive reframing [1.96 (0.49, 3.44), p = 0.011], reduction in self-blame −1.64 (−3.20, −0.08) p = 0.040], and instrumental support [1.78 (0.29, 3.28), p = 0.02] was noted at 3 months. There was a significant improvement in coping with spirituality/religion at 3 months [1.18 (0.11, 2.25), p = 0.032], but not at 6 months in the compliant group. There was a significant reduction in stress levels [5.16 (0.80, 9.51), p = 0.02] and an improvement of physical HRQOL [5.16 (0.80, 9.51), p = 0.02] at 6 months. There was a trend toward an improvement in mental HRQOL [4.93 (−0.18, 10.05), p = 0.058] at 6 months as well, but this was not significant. There were no significant differences in healthcare utilization between the two groups at both 3 and 6 months between compliant patients and controls.

4 |. DISCUSSION

To our knowledge, this is the first prospective randomized trial to determine the efficacy of an integrative healthcare model on healthcare outcomes in CVS. We found that incorporating meditation and care coordination improved coping strategies and physical HRQoL. However, there was no significant improvement in psychological distress, which was the primary outcome and also healthcare utilization. Subgroup analysis showed a greater benefit in patients who were compliant with the protocol. These patients showed a reduction in psychological distress, improvement in sleep quality, additional domains of coping, and a reduction in perceived stress.

While some studies using mindfulness-based techniques have been shown to improve mood, reduce stress, and symptom severity in IBS, our study is unique in the type of meditation that we used and offers several advantages. Heartfulness meditation can be practiced remotely and has over 6000 trainers worldwide who offer their services free-of-charge. This offers a distinct advantage over mindfulness-based meditation sessions that often involve classes in real time and may not be feasible for most participants. These classes can potentially be expensive,time-consuming, and may require considerable logistical planning to attend them.^13,26 Additionally, the HI Institute has multiple online classes and a Hearts app, which participants can use to connect with a trainer 24 hours a day. For these reasons, Heartfulness meditation is a practical and simple method that can be employed in clinical care settings.

As this was an integrated model, we were unable to differentiate the individual effects of the meditation vs care coordination. While many of the effects on domains of coping, stress, and HRQoL are likely the result of the combination of meditation and care coordination, patients in the IHC group tended to lean toward spirituality/religion at both 3 and 6 months. This effect is most likely due to the meditation practice per se. The care coordinator interacted with the patients on a monthly basis at minimum and more frequently if needed and encouraged patients to engage in healthy behaviors, which may also have contributed to the improvement in stress levels and enhanced coping mechanisms. The care coordinator was specifically instructed to help patients with their meditation program but despite this, the independent effects of meditation versus care coordination need to be determined in future studies.

Our study did not show a decrease in healthcare utilization. In fact, there was a slightly increased rate of hospitalizations in the IHC group. These findings need to be interpreted with caution. Though all patients seen in our specialized clinic are given specific instructions for care in the ED and hospital, patients, in general, prefer to avoid the ED and the hospital due to the long waits and frustration with care given the general lack of knowledge about CVS.²⁷ It is possible that having a care coordinator encouraged patients to seek medical care either in the ED and/or hospital despite their reservations. The care coordinator helped patients navigate the healthcare system which may explain this increased utilization. Additionally, the patients in the IHC group were sicker at the outset though this was not significant. Further, as this was an intention-to-treat analysis, we included all hospitalizations that were potentially related to CVS in our analysis. Just one patient in the IHC group had multiple interventions related to complications from placement of a central venous catheter, which may have influenced the results. Future long-term studies designed specifically to determine this outcome need to be performed before any definitive conclusions can be made regarding the effects on healthcare utilization. Identifying patients who are better suited to benefit from this model of care and implementing these interventions in these selected patients can improve outcomes and also optimize resources. Our study findings clearly demonstrated a greater benefit in patients who were compliant. This may underscore the need to include only those patients who are more likely to invest the time and effort needed to achieve positive results.

There are limitations to our study. First, most patients in our study did not meditate on a daily basis and this may have affected the outcomes. However, as with other behavioral interventions, sustaining a daily meditation practice can be challenging and our study mirrors what would likely happen in a real-world setting and is thus more valid. Further, compliant patients had significantly better outcomes compared to those who were not. Though we instructed patients to maintain a diary for their own personal reflection, we did not mandate this. This limited our ability to measure their adherence to the meditation protocol. We intend to develop an app to have patients self-report meditation sessions in the future. However, there is a lack of high-quality studies using this innovative approach especially in disorders of gut-brain interaction, and this study provides a useful framework for future research in this area. One uncontrolled study using a mind-body relaxation technique in 19 IBS and 29 IBD patients showed an improvement in trait anxiety and pain over a 9-week period.²⁶ Our study also does not allow us to differentiate the independent effects of the Heartfulness meditation vs. the care coordinator. However, it is important to note that such an integrated approach is essential in managing patients with chronic care conditions and is likely to be more effective in achieving better healthcare outcomes, than implementing one or the other. We are in the process of conducting studies to study the independent effects of Heartfulness meditation and the care coordination. Our study was limited to 6 months and it is unclear how effective such an approach would be over a longer period of time. However, this is significantly longer than other studies using techniques to reduce stress and further support our recommendation that such an approach is both effective and feasible. Our study also did not show a reduction in healthcare utilization but our study was not powered to study this outcome. We propose to conduct larger trials in the future to answer this question.

Another potential limitation was the use of multiple instructors. All instructors were certified and followed the same method/protocol for each patient. Given the number of participants and logistic issues, it would not have been feasible to use a single instructor. When adjusting for instructor effects using a random-effects model, acceptance as a means of coping was significant in the IHC group while use of spirituality/religion remained significant at 3 months but not at 6 months. As the primary intent was to test the efficacy of the intervention, and not of specific instructors, this will need to be studied in future larger studies. Any potential variation between the effectiveness of different instructors is part of any intervention and likely enhances the generalizability of the results. This would only strengthen the application of this model in a real-world setting where such variability would be expected. Further, predictors of response to meditation are likely impacted by trainee characteristics such as compliance, belief systems surrounding meditation, and possibly genetic and environmental characteristics, rather than the trainer. This is an important research question and warrants further study to identify subjects who are more likely to respond to such meditation. Other limitations include the absence of a validated tool to assess CVS symptom severity. Our study was not powered to for this particular outcome, and we intend to address this in future studies. However, we assessed all our primary outcomes with validated tools to measure coping strategies and levels of stress and demonstrated an improvement. It is well known that psychological stress and poor coping can worsen disorders of gut-brain interaction and quality of life irrespective of specific gastrointestinal symptoms. While our statistical methods were robust and we used a p < 0.05 as being significant, the potential for higher than quoted possibility of type I error due to multiple hypothesis testing cannot be ruled out. On the other hand, it is also possible that we might have detected differences in other outcomes with a larger sample size. Despite these limitations, our study supports the concept of providing holistic care in patients with CVS. Disease models that address the overall health of a population have not gained traction, particularly in the GI community, and our pilot study serves as a proof-of-concept study and demonstrates both feasibility and a framework for improving overall delivery of health care.

In summary, an integrated healthcare model incorporating meditation and care coordination improved physical HRQoL and coping mechanisms but did not improve psychological distress, which was the primary outcome. There was a slight increase in hospitalizations in the IHC group, but this may be due to the increased attention and encouragement which the IHC group tended to receive and may reflect the mitigation of some of the barriers that patients face when seeking care for CVS during an acute episode. Additional benefit was seen in compliant patients with reduction in psychological distress (primary outcome), reduction in perceived stress,improvement in sleep quality, and further improvement in multiple domains of coping. Despite these modest findings, this study demonstrates that an IHC model is both feasible and effective in clinical practice. Such a model is designed to meet the individual needs of patients and address barriers to psychosocial barriers to health. Incorporating and engaging community partners such as HI which has an international presence and incorporating a care coordinator can significantly improve healthcare outcomes by improving coping and reducing stress. This study should help inform future long-term studies and help inform policy makers and hospital management to incentivize and encourage holistic models of care in CVS and other chronic disorders.

Key Points.

• Episodes of cyclic vomiting syndrome (CVS) are often triggered by stress and have a significant psychosocial impact. Our current model of care does not address these psychosocial barriers to health.

• An integrative healthcare model incorporating heartfulness meditation and care coordination improved coping mechanisms and quality of life in CVS.

• This model of care can be incorporated successfully in clinic in addition to usual care to achieve better healthcare outcomes in these patients.

DATA AVAILABILITY STATEMENT

Data available in article supplementary material.