An Integrative, Patient-Centered Model of Care: Meditation and Care Coordination to Improve Healthcare Outcomes in Cyclic Vomiting Syndrome
Cyclic vomiting syndrome is a chronic functional gastrointestinal disorder that is a significant health care problem. It affects 1-2% of the population and imposes an enormous burden on patients, families and the health care system. Due to the recalcitrant nature of the disease, patients have high rates of health care utilization with multiple emergency department visits and hospitalizations. These in turn lead to school and work absenteeism, job loss, divorce and even disability. CVS is also associated with multiple comorbid conditions such as anxiety and depression, which further contribute to disease severity. Both neuroimaging studies and other data demonstrate the role of the central nervous system in the pathophysiology of CVS with stress being a significant trigger for episodes of CVS. In summary, CVS is common, disabling and expensive and is associated with significant psychosocial comorbidity that contributes to impaired quality of life . Our current healthcare delivery model is disease-centric and does not adequately address the psychosocial barriers that contribute to poor health in this patient population. We propose a novel, collaborative, integrative health care model that shifts the paradigm of care from one that is episodic and disease-centered to a patient-centered approach that addresses psychosocial determinants of health not addressed in our current traditional health care system. We will incorporate meditation practices that have been shown to reduce psychological distress and also add a care coordinator to our health care delivery team. The primary role of the care coordinator is to identify patient goals, preferences and barriers to self-management and address psychosocial and environmental issues that determine health. Patients will be randomized to either the integrative health care model or usual care. The primary aim of our study is to determine the impact of our proposed integrative health care model on health care outcomes which will include a reduction in psychological distress, improvement in coping skills for managing chronic disease, cognitive symptom management, improvement in health-related quality of life and reduction in health care utilization. This collaborative effort between physicians, community partners, and allied health personnel will redesign the health care delivery system, facilitate access to appropriate healthcare services, optimize chronic disease management and improve overall healthcare outcomes.
NCT04329637 — Cyclic Vomiting Syndrome
Status: Completed
http://inclinicaltrials.com/cyclic-vomiting-syndrome/NCT04329637/
Using Meditation to Treat Anxiety and Improve Quality of Life in Prostate Cancer Patients Receiving Radiation Therapy
The current study is a prospective, interventional, randomized, treatment-controlled study, evaluating the use of Meditation with a Mantra (MM) to decrease anxiety levels and improve Quality of Life (QOL) in prostate cancer patients receiving radiation treatment. The study will be conducted across 6 radiation treatment sessions in men with newly diagnosed prostate cancer, Stage 1 to 3A, and men with recurrent prostate cancer. Patients will receive six radiation sessions with usual care with or without the addition of MM. MM Group patients will be given a log at the beginning of the study to record how long they are meditating and if they found meditation beneficial. The General Anxiety Disorder-7 scale (GAD-7) is a validated tool and will be used to assess anxiety in all participants. The Functional Assessment of Cancer Therapy-Prostate, Version 4 (FACT-P) is a validated measure of QOL in prostate cancer patients and will be used to assess QOL in all participants. A one month follow up phone call will determine if the patients are continuing to use the MM and if they found the practice of MM useful not only in their radiation treatment sessions but in their everyday lives.
NCT04312191 — Prostate Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/prostate-cancer/NCT04312191/
A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment. This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.
NCT04303013 — Cancer
Status: Completed
http://inclinicaltrials.com/cancer/NCT04303013/
Meditation and Yoga for Irritable Bowel Syndrome Study
Study Aim: This study will explore the feasibility and effectiveness of a yoga program for patients with IBS. Methods: A superiority RCT with 30 participants per group. Adult patients with IBS fluent in English who do not have major physical impairments or cognitive, psychological, or psychiatric disorder will be recruited and randomly using the REDCap randomization module to either a yoga intervention delivered (a) a yoga intervention delivered online led by a yoga facilitator or (b) a advice only control group. The 8-week Hatha Yoga intervention consists of Yoga Namaskar, Nadi Shuddhi (alternate nostril breathing), mantra chanting, and breath watching. Group 1: Yoga program. Participants will be asked to practice the yoga program daily at home and will be given access to the yoga videos hosted on the University of Calgary study website, as well as written program instructions, and frequently answered questions. A brief description of the video content will be provided to inform the participant of its content and length. Additional website content will include study information, study schedule, and contact information, as well as a pre-recorded educational session. In addition to the daily program describe above, the facilitator-led intervention will be delivered online by a certified yoga facilitator using the Microsoft Teams platform. Participants in group of 3 to 5 will be collated to enhance effectiveness of the study processes. Our team has experience with this approach, as this strategy is currently used with previous yoga study. Yoga classes will be held once per week for 8 weeks, with the first session lasting approximately 1.5 hours and subsequent sessions up to 60 minutes. The total allocated time for the introductory session will include the class set-up, introductions, educational material (please see below), overview of practices, teaching of practices, practice corrections/enhancements, modifications, and practice expectations. Each follow-up class will include review from the previous week, questions and answers, individual corrections and/or modifications. For individual corrections, the yoga facilitator will ask the participant to do the practices and receive corrections, if needed. Group 2. Advice-only control group. This group will receive general education on IBS, the mind and gut connection, and the role of mind-body therapies in the management of IBS. Effectiveness outcomes will be assessed at baseline and 8 weeks. The primary effectiveness outcome will be the severity of IBS symptoms, and secondary effectiveness outcomes include microbiome analysis, quality of life, anxiety and depression symptoms, perceived stress, fatigue, and severity of somatic symptoms. Microbiome composition will be measured using shotgun metagenomic sequencing. Microbiome sequences will be analyzed for alpha diversity, beta diversity, species composition, functional composition and biomarker discovery. To determine the feasibility of each intervention, recruitment and attrition rates, adherence, program preferences and satisfaction, and adverse event outcomes will be evaluated.
NCT04302623 — Irritable Bowel Syndrome
Status: Completed
http://inclinicaltrials.com/irritable-bowel-syndrome/NCT04302623/
Effects of Progressive Muscle Relaxation and Mindfulness Meditation on Dyspnea, Fatigue and Care Dependency in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study
Patients with COPD will be entered. Participants will be randomized to one of three study arms: Arm 1: meditation; Arm 2: relaxation; Arm 3: Control. Hypothesis: Progressive muscle relaxation and mindfulness meditation will decrease severity of dyspnea, fatigue and care dependency.
NCT04301700 — COPD
Status: Active, not recruiting
http://inclinicaltrials.com/copd/NCT04301700/
Progressive Muscle Relaxation and Mindfulness Meditation on Neuropathic Pain, Fatigue and Quality of Life in Type 2 Diabetes Patients: A Randomized Clinical Trial
Patients with painful diabethic peripheral neuropathy will be entered.. Participants will be randomized to one of three study arms: Arm 1: relaxatio; Arm 2:meditation Arm 3: Attention matched control Hypothesis: Progressive muscle relaxation and mindfullness meditation will decrease severity of neuropathc pain and fatigue and improve quality of life.
NCT04287439 — Neuropathy, Diabetic
Status: Completed
http://inclinicaltrials.com/neuropathy-diabetic/NCT04287439/
Mindfulness Meditation and Sleep Disturbances in Hematopoietic Cell Transplant Patients: Inflammatory Mechanisms
This randomized, controlled study will compare Mindfulness Awareness Practices for Insomnia (MAP-I) to sleep health education (SHE) in subjects receiving autologous hematopoietic cell transplant for multiple myeloma.
NCT04271930 — Multiple Myeloma
Status: Recruiting
http://inclinicaltrials.com/multiple-myeloma/NCT04271930/
CALM Pregnancy: Feasibility of Mindfulness-based Prenatal Stress Reduction Using a Smart Phone Meditation Application
The purpose of this study is to determine the feasibility of using a consumer-based mindfulness app, Calm, to reduce stress during pregnancy. Women will be randomly assigned to an intervention group (i.e., Calm) or standard care group and asked to participate in at least 10 minutes of daily meditation for the duration of their pregnancy (i.e., 12-weeks' gestation up to date of birth). Aim #1: Determine the feasibility (acceptability and demand) of using the Calm app at least 10-minutes per day for the duration of pregnancy (i.e., 12-weeks' gestation up to date of birth). Acceptability will be measured with an investigator-developed satisfaction survey. Demand will be measured using time spent in meditation and meditations used (tracked by Calm). For the intervention group, the benchmarks will be as follows: 1. Acceptability (i.e., satisfaction) 70% (n=34) of participants will report a 75% satisfaction, 2. Demand (i.e., time spent in meditation and meditations used,) 70% (n=34) of participants will adhere to ≥75% of prescribed meditation using Calm. Aim #2: Determine the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on stress. Stress will be measured using the Perceived Stress Scale (PSS) at baseline (i.e., 12-16-weeks' gestation) and every four weeks for the duration of the intervention using Ecological Momentary Assessment (i.e., text message). Stress will also be measured using cortisol serum at baseline (i.e., 12-16-weeks' gestation), and 32 weeks' gestation. Exploratory Aim #3: The investigators will explore the preliminary effects of using Calm at least 10-minutes per day for the duration of pregnancy (i.e., 12-16 weeks' gestation to date of birth) on gestational age of birth, fetal weight, APGAR scores (i.e., health score), and neonatal complications with time spent in neonatal intensive unit (if applicable).
NCT04264910 — Pregnant Women
Status: Completed
http://inclinicaltrials.com/pregnant-women/NCT04264910/
Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study
The primary objective will be to study changes in putamen structural connectivity in healthy teens with meditation training. Hypothesis: Putamen structural node strength will increase in the training group compared to controls. R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d > 0.20) in changes of the primary mechanistic outcome (Putamen structural node strength) by the described meditation training in 100 healthy adolescents that are 14-18 years old and retain at least 80% of randomized participants for primary outcome measurement at the end of the study regardless of adherence to the intervention. The secondary objective will be to study changes in emotional problems in healthy teens with meditation training. Hypothesis: There will be a significant decrease in emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group compared to controls. Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action [TARA]) on the primary outcome (Putamen structural node strength) and secondary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire [SDQ]) in healthy adolescents between the ages of 14 to 18 years old.
NCT04254796 — Healthy
Status: Completed
http://inclinicaltrials.com/healthy/NCT04254796/
Meditation Based Lifestyle Modification in Healthy Individuals
MBLM is a holistic therapy for people with mental disorders whose positive effects on patients with depression have already been demonstrated in clinical use and a pilot study. In the present study, the differential effects of MBLM domains (ethical living, healthy lifestyle, and mantra meditation) on healthy volunteers will be investigated.
NCT04252976 — Mantra Meditation + Body-Oriented Yoga
Status: Completed
http://inclinicaltrials.com/mantra-meditation-body-oriented-yoga/NCT04252976/