An Internet-administered Randomized Control Trial to Examine the Effects of Regular, Brief Meditation Practice on Mental Health and Well Being
The study will examine the effects of online meditation training on stress and anxiety in healthy participants. It will also examine the dose-response relationship between the amount of daily focused attention meditation practice and established mental health outcome measures.
NCT06014281 — Healthy
Status: Recruiting
http://inclinicaltrials.com/healthy/NCT06014281/
Heartfulness Meditation: Acute and Long-term Effects on the Endocannabinoid Signaling System and Correlation With Psychological Outcomes in Cyclic Vomiting Syndrome
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.
NCT05961995 — Cyclic Vomiting Syndrome
Status: Recruiting
http://inclinicaltrials.com/cyclic-vomiting-syndrome/NCT05961995/
Impact of Breathing Exercises and Meditation on Improving Quality of Life in Glaucoma Patients: An Electronic Pilot Feasibility Study
Glaucoma is a chronic disease that causes loss of vision and potentially blindness as a result of optic nerve damage, often due to increased intraocular pressure. Glaucoma is currently the leading cause of irreversible blindness worldwide.1 In 2020, 4.1 million and 3.6 million adults over the age of 50 suffered from mild to severe glaucoma-induced visual impairment and blindness, respectively.1 However, these figures are likely underestimated since glaucoma can remain asymptomatic until later stages in disease progression.2 The relaxation response evoked by mind-body interventions, such as breathing exercises and meditation, is known to reduce stress and improve quality of life (QOL). In a recent study, mindfulness-based meditation was found to reduce intraocular pressure and improve QOL in patients with glaucoma.3 A feasibility study will be conducted using a mixed-method design to assess the feasibility of the online delivery of an intervention titled Breathing Exercises followed by Meditation for potentially enhancing the QOL and mental health of glaucoma patients. Upon recruitment, participants will undergo blocked randomization to either the intervention arm or usual care arm, stratified by sex. Participants in each arm will complete online questionnaires at baseline and after 12 weeks to collect data on health-related quality of life (HRQOL), depression symptoms, anxiety, and sleep quality using REDCap, an electronic data capturing system provided by Lawson Health Research Institute (LHRI). Our study can help to assess the feasibility of conducting a pilot study on breathing exercises followed by meditation to assess its effects in a sample of patients with glaucoma.
NCT05960513 — Depression
Status: Not yet recruiting
http://inclinicaltrials.com/depression/NCT05960513/
The GEMM Trial: Graded Exposure and Mindfulness Meditation for Patients Post- ACL Reconstruction
To evaluate the effect of graded exposure and mindfulness meditation after ACLR, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.
NCT05949177 — Anterior Cruciate Ligament Injuries
Status: Not yet recruiting
http://inclinicaltrials.com/anterior-cruciate-ligament-injuries/NCT05949177/
The PRYME Study: Promoting Resilience in Youth Through Mindfulness mEditation.
The aim of this randomized controlled trial (RCT) is to assess whether mindfulness training reduces early stage internalizing problems such as anxiety, worrying, and low mood in help-seeking youth. Participants will be randomly assigned to one of two groups: 1) mindfulness + care-as-usual (CAU) or 2) CAU-only. The mindfulness program was developed specifically for youth with internalizing problems. The 8-week training program consists of weekly 2-hour sessions, with mindfulness, yoga, and mindful active movement in each session. In addition, participants are invited to practice at home in between sessions for around 20 minutes per day. Data will be collected at baseline (T0), end-of-treatment (T1) (or 2-3 months after baseline for the CAU-only group), and at 2 months follow-up (T2) and 6 months follow-up (T3). Measurements will include: - Self-report questionnaires (T0, T1, T2, T3) - Psychiatric diagnostic interview (T0, T3) - MRI scans (T0, T1) - Cognitive tasks (T0, T1) The primary outcome parameter is the total number of internalizing problems measured with the Adult Self Report (ASR) at end-of-treatment. The effect of mindfulness training (mindfulness + CAU vs. CAU-only) on internalizing problems at T1 will be assessed using a linear-mixed effects model.
NCT05916651 — Internalizing Problems
Status: Recruiting
http://inclinicaltrials.com/internalizing-problems/NCT05916651/
Meditation, Education, Navigation, & Training Using eHealth: Cancer Adaptation Through Learning Mindful Awareness
The purpose of this international oncology research includes the following three aims: - Aim 1. Expand and strengthen the existing research partnership with investigators from Centro Javeriano de Oncología, Pontificia Universidad Javeriana, and Hospital Universitario San Ignacio in Bogotá, Colombia. - Aim 2. Evaluate the implementation feasibility and acceptability of the 9-week Spanish-translated mindfulness app, Wakeful, in a mixed Colombian young adult cancer patient sample. - Aim 3. Translate and record professional Spanish-language voice overs for all new STU00210628 content for future implementation.
NCT05912166 — Cancer
Status: Recruiting
http://inclinicaltrials.com/cancer/NCT05912166/
Who Fares Best With Mindfulness Meditation - Understanding the Individual Effects of Mindfulness
The overall aim of this observational study is to investigate how individual differences influence the effects of mindfulness meditation to uncover for whom mindfulness is beneficial and for whom it may be harmful. The first objective is to identify the mechanisms underlying the effects of mindfulness meditation on mental health. The second objective is to examine how three candidate factors, namely trauma symptoms, tendency to dissociate, and repetitive negative thinking, influence the effect of mindfulness meditation on mental health. Adults who enrolled for a Mindfulness-Based Intervention (MBI) at the participating sites (n=120 for each site) will be invited to participate. Before the start of the MBI, after half of the sessions, at the end of the MBI and at 3-months follow-up, participants will complete self-report questionnaires. The main outcomes are symptoms of anxiety and depression, quality of life, wellbeing, and adverse effects resulting from the MBI. A subset of participants will be invited for a semi-structured interview after the end of the intervention.
NCT05862636 — Healthy
Status: Recruiting
http://inclinicaltrials.com/healthy/NCT05862636/
Using a Technology-based Meditation Program Administered Through the iom2 Biofeedback Device to Reduce Depression and Anxiety and Improve QOL in the Inpatient Stroke Rehabilitation Setting
The goal of this clinical trial is to investigate the impact of a technology-based meditation program in the inpatient stroke population. It will explore how this approach can support patient-centred, holistic, compassionate care by reducing symptoms of depression and anxiety and improving quality of life. Patients will be recruited from the inpatient stroke rehabilitation unit and will have sustained a stroke in the past 2 months. The main question[s] it aims to answer are: 1. Is using a technology-based meditation program in the prevention and/or improvement of post stroke depression and anxiety effective for inpatient stroke survivors? 2. Does using a technology-based meditation program support patient-centered, holistic and compassionate care and result in improved measures of quality of life? Those in the treatment arm will be asked to complete the following: - complete 2-3 scales on admission and discharge - participate in meditation therapy at least three times per week for a minimum of 10 minutes per session. Participate in education and demonstration of the meditation app and use of the iom2 device - use the iom2 (technology supported meditation and biofeedback) device to monitor heart rate variability and resonance scores - participate in an informal discussion re: experience with software and biofeedback In this randomized controlled trial, those allocated to the control group (standard care) will undergo their usual inpatient rehabilitation but will be asked to complete the outcome measures on admission and prior to hospital discharge.
NCT05845541 — Stroke
Status: Not yet recruiting
http://inclinicaltrials.com/stroke/NCT05845541/
Decreasing Sedative Requirements for Peripheral Vascular Interventions Using Preoperative Guided Meditation
The primary purpose of this clinical trial is to test the feasibility of implementing a perioperative guided meditation program for patients undergoing peripheral vascular interventions that are performed under procedural sedation and analgesia.
NCT05837481 — Peripheral Vascular Disease
Status: Active, not recruiting
http://inclinicaltrials.com/peripheral-vascular-disease/NCT05837481/
Effects of Transcendental Meditation on Rural Women of Lebanon
The goal of this clinical trial is to compare the experiences of women who learn the TM technique to those who do not. The main questions it aims to answer are: 1. Do women in rural Lebanon who practice the TM technique experience lower stress levels compared to those who do not. 2. Do women in rural Lebanon who practice the TM technique experience increased happiness, self-efficacy, and resilience levels compared to those who do not. Participants will: - complete baseline surveys - be divided into experimental and active-control groups - those in the experimental group will learn the TM technique, the control group will be offered an online didactic course on stress reduction - both groups will complete post-test surveys at the end of 1 and 3 months - Researchers will compare experimental and control groups to see if the intervention effects stress levels.
NCT05836129 — Stress
Status: Completed
http://inclinicaltrials.com/stress/NCT05836129/