Acute and Long-term Effects of App-delivered Heartfulness Meditation on Psychological Outcomes and the Endocannabinoid Signaling System in Cyclic Vomiting Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
研究概览
简要总结
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.
The endocannabinoid signaling system (ECSS) is activated by stress exposure and functions through multiple neuroendocrine responses to mitigate the negative effects of stress. We examined the role of the ECSS in CVS and found that endocannabinoids were not elevated during an acute CVS episode. This lack of a response in the ECSS during an acute CVS episode, which is characterized by panic, intense nausea and vomiting is striking, given that the ECSS is typically activated by stress exposure. This may reflect an underlying dysfunction of the ECSS in CVS and impaired stress responsivity. Given these data and our preliminary findings of the beneficial effects of HFN meditation, our central hypothesis is that HFN meditation will increase circulating endocannabinoids in CVS and that this will be correlated with a reduction in anxiety and other psychological outcomes and overall quality of life.
We propose to test our hypothesis with the following specific aims
Specific Aim 1a: 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.
1b: Correlate indices of ECSS with state anxiety and mood pre-and post-HFN meditation. We will measure state anxiety and mood with validated tools including the State Trait Anxiety Inventory (STAI) and Profile of Mood States (POMS) which evaluates tension, depression, anger, vigor, fatigue, and confusion.
Hypothesis: HFN meditation will acutely increase circulating endocannabinoids which will be correlated with a reduction in state anxiety and improvement in mood.
Specific Aim 2: Determine the long-term effects of a 6-week HFN meditation program on ECSS and correlate with psychological outcomes including psychological distress, STAI scores, sleep quality, and HRQoL. We will measure these outcomes with validated tools including the Brief Symptom Inventory (BSI), STAI, Pittsburgh Sleep Quality Index (PSQI), and PROMIS quality of life questionnaires.
Hypothesis: A regular HFN meditation practice over 6 weeks will further augment ECSS, and this will be correlated with an improvement in psychological outcomes such as psychological distress, sleep, mood and HRQoL.
详细描述
Research Design
Design: We will conduct a single-arm uncontrolled pilot study with 40 patients. Patients aged 18-80 years diagnosed with CVS based on Rome criteria will be eligible to participate.
Exclusion criteria: 1. 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 2. History of suicidal attempt/ideation in the past year 3. Cognitive impairment that precludes the ability to meditate 4. Inability to sit for at least 30 minutes 5. Severe cardiopulmonary diseases, malignancy, or renal failure on dialysis 6. Other organic gastrointestinal diseases or systemic diseases including but not limited to inflammatory bowel disease and chronic liver diseases 7. Pregnancy at the time of enrollment 8. BMI < 18 or >35 9. Regular cannabis use (defined as daily or near-daily cannabis use) and 10. Individuals with significant prior meditation experience (continuous meditation practice for ≥ 3 months within a year prior to the study).
Patients will come for 2 study visits. 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. The app will automatically document meditation compliance, and study staff will be able to remind patients if compliance is inadequate. The app will be HIPAA compliant and only study staff will have access to PHI.
Study procedures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 - 80 years of age
- •Diagnosed with CVS based on Rome criteria
排除标准
- •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).
结局指标
主要结局
State-Trait-Anxiety Inventory (STAI) (18) and Profile of Mood States (POMS)
时间窗: 6 weeks
The primary outcomes were state and trait anxiety and mood states, measured using the State-Trait-Anxiety Inventory (STAI) and Profile of Mood States (POMS) respectively. The STAI-S evaluates current feelings of apprehension, tension, nervousness, and worry. The scale consists of two 20-item subscales and four rating categories including very much so, moderately so, somewhat and not at all. Scores for STAI range from 20 to 80. Higher scores indicate great anxiety, lower scores indicate no or low anxiety. The POMS is a 35-item validated questionnaire that assesses mood states of tension, depression, anger, vigor, fatigue and confusion. There is a variation in the range of scores for each subscale, with the lowest being 0 and the highest 60. A lower score indicates a better mood, and vice versa. Total score is calculated by summing the totals for the negative subscales and then subtracting the totals for the positive subscales with a higher score indicating worse mood disturbance.
次要结局
- Brief Symptom Inventory (BSI) - General Severity Index (GSI), Health-related Quality of Life (PROMIS), Sleep Quality (Pittsburgh Sleep Quality Index) Coping (COPE), and Visual Analog Scale (VAS) Effectiveness Score(6 weeks)
研究者
Thangam Venkatesan
Principal Investigator
Ohio State University