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Trials

ISSN 1745-6215

66 papers in the library · 203 citations · publishing 2010-2026

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Promoting psychological well-being in preschool children: study protocol for a randomized controlled trial of a mindfulness- and yoga-based socio-emotional learning intervention.

Trials December 27, 2022 Ophélie Courbet, Quent Daviot, Victoire Kalamarides et al.

Mental health issues in youths have cascading negative effects on school outcomes, professional life, and physical health. Psychological well-being (P-WB) is an important protective factor against mental illness. Preliminary research suggests that mindfulness- and yoga-based socio-emotional learning (SEL) interventions can each have a positive impact on preschoolers P-WB. The objective of this...

Internet delivered, non-inferiority, two-arm, assessor-blinded intervention comparing mindfulness-based stress reduction and cognitive-behavioral treatment for insomnia: a protocol study for a randomized controlled trial for nursing staff with insomnia.

Trials December 16, 2022 Yaling Li, Nabi Nazari, Masoud Sadeghi

Insomnia and poor sleep quality are highly prevalent conditions related to coronavirus disease 2019 (COVID-19) complications among clinical nurses. Although cognitive behavioral therapy for insomnia (CBT-I) is a first-line treatment, CBT-I suffers from several major drawbacks. This study investigates whether the application of the internet-delivered mindfulness-based stress reduction (iMBSR)...

Effectiveness of Anapana, Body scan and Metta meditation techniques on chronic neck and shoulder region pain and disability in adult patients in Sri Lanka: study protocol for a cluster clinic-level randomised controlled trial

Trials November 15, 2022 Aranjan Lionel Karunanayake, Emma Solomon-Moore, Nikki Coghill

Abstract Background Chronic neck and shoulder region pain affects many people around the world. This study aims to compare the effectiveness of three 8-week meditation training programmes (each using a different meditation technique: Anapana, Body scan or Metta) on pain and disability in a patient population affected with chronic neck and shoulder region pain, with a usual care control group...

Effects of meditation on physiological and metabolic parameters in patients with type 2 diabetes mellitus "MindDM": study protocol for a randomized controlled trial.

Trials September 30, 2022 K P C Dalpatadu, P Galappatthy, P Katulanda et al.

Sri Lanka is faced with the challenge of managing a large population with diabetes mellitus by 2030. Psychological stress plays a major role in disease outcome by exerting physiological, psychological and social effects on individuals with chronic disorders. Meditation-based interventions have positive effects on the management of stress and diabetes, which are mediated via modulation of...

The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial.

Trials September 24, 2022 Sunny Ho-Wan Chan, Siu-Man Ng, Chong Ho Yu et al.

Background: Many elderly individuals who experience sleep disturbances would consider complementary and alternative medicine as an alternative therapeutic option in light of the limitations of traditional treatments. Mindfulness-based interventions (MBIs) and Tai Chi Chuan (TCC) are two alternative forms of complementary and alternative medicine. They both share the common feature of a focus on...

Effectiveness of a Mindful Compassion Care Program in reducing burnout and psychological distress amongst frontline hospital nurses during the COVID-19 pandemic: a study protocol for a randomized controlled trial

Trials September 2, 2022 Luca Bodini, Chiara Bonetto, Simone Cheli et al. 14 citations

BACKGROUND: Recent studies have shown that nurses have been more affected by the COVID-19 pandemic than any other group of hospital workers in terms of anxiety, depression, and burnout. Several clinical studies had previously demonstrated the effectiveness of mindfulness and compassion interventions in reducing burnout and emotional distress amongst healthcare professionals. METHODS AND...

The modulatory role of internet-supported mindfulness-based cognitive therapy on extracellular vesicles and psychological distress in people who have had cancer: a protocol for a two-armed randomized controlled study.

Trials February 5, 2022 Diana R Pereira, Eunice R Silva, Carina Carvalho-Maia et al.

Mindfulness-based interventions (MBIs) have been used in oncology contexts as a promising tool with numerous benefits for various health-related and psychosocial outcomes. Despite the increasing popularity of MBIs, few randomized controlled trials (RCTs) have examined their effects upon biological parameters. Specifically, no previous study has examined the effects of MBIs on extracellular...

DOI: 10.1186/s13063-022-06045-x (opens in new tab) Full text (opens in new tab) Cancer Distress Extracellular vesicles Internet +4

Mindfulness-based stress reduction intervention for elementary school teachers: a mixed method study.

Trials November 21, 2021 Johanna H. Lensen, Sabine E. M. J. Stoltz, Marloes Kleinjan et al.

Background: In the Netherlands, more than half of the teachers working in primary education experience high levels of work stress. Compared to other professions, teachers are more likely to drop out from work and develop mental illnesses. Almost one in five even choose a new profession within 5 years after starting as a teacher. This indicates an urgent need for interventions to reduce stress...

MDLSD: study protocol for a randomised, double-masked, placebo-controlled trial of repeated microdoses of LSD in healthy volunteers

Trials April 23, 2021 Robin J Murphy, Rachael Sumner, William Evans et al. 23 citations

BACKGROUND: Regular ingestion of sub-hallucinogenic doses of psychedelics, referred to as "microdosing", has gained increasing popularity and attention in the press and in online forums, with reported benefits across multiple cognitive and emotional domains. Rigorously controlled studies to date, however, have been limited in scope and have failed to produce results comparable to those reported...

Effectiveness of using a meditation app in reducing anxiety and improving well-being during the COVID-19 pandemic: A structured summary of a study protocol for a randomized controlled trial

Trials December 1, 2020 Katherine T. O’Donnell, Melanie Dunbar, Diana Speelman

This interventional study will investigate the effect of daily use of a mindfulness app on measures of participant anxiety, well-being, and perceived outlook during the COVID-19 pandemic, by comparing pre-intervention survey responses to post-intervention survey responses. Randomized, controlled trial with parallel assignment. Adults will be assigned either to daily use of a meditation app for...

A tai chi/qigong intervention for older adults living with HIV: a study protocol of an exploratory clinical trial.

Trials September 22, 2020 Gladys E Ibañez, Kristopher Fennie, Linda Larkey et al.

Background: Almost half of people living with HIV (PLWH) in the USA are over 50 years of age; this is expected to increase to 70% by 2020. Yet, few interventions exist for older PLWH that address psychological and physical symptoms combined, both prevalent in this population. There is a need to find innovative and accessible interventions that can help older PLWH to manage their symptoms....

Sahaj Samadhi Meditation versus a Health Enhancement Program for depression in chronic pain: protocol for a randomized controlled trial and implementation evaluation

Trials January 8, 2020 Abhimanyu Sud, M. Nelson, Darren K. Cheng et al.

Background Despite the high prevalence of comorbid chronic pain and depression, this comorbidity remains understudied. Meditation has demonstrated efficacy for both chronic pain and depression independently, yet there have been few studies examining its effectiveness when both conditions are present concurrently. Furthermore, while meditation is generally accepted as a safe and effective health...

Metta-based group meditation and individual cognitive behavioral therapy (MeCBT) for chronic depression: study protocol for a randomized controlled trial.

Trials January 6, 2020 Artjom Frick, Isabel Thinnes, Ulrich Stangier

Depression is a widespread disorder with severe impacts for individuals and society, especially in its chronic form. Current treatment approaches for persistent depression have focused primarily on reducing negative affect and have paid little attention to promoting positive affect. Previous studies have shown that metta meditation increases positive affect in chronically depressed patients....

DOI: 10.1186/s13063-019-3815-4 (opens in new tab) Full text (opens in new tab) Mindfulness Chronic depression Cognitive behavioral therapy Loving kindness meditation +3

A mindfulness and compassion-based program applied to pregnant women and their partners to decrease depression symptoms during pregnancy and postpartum: study protocol for a randomized controlled trial.

Trials November 28, 2019 Olga Sacristan-Martin, Miguel Á Santed, Javier García-campayo et al.

Background: Pregnancy and the postpartum period are times of great change for women and their partners, often bringing substantial challenges and stress. Approximately 10%-20% of women suffer from mood disorders such as depression in the perinatal period. There are risks involved in using psychopharmacological interventions to treat perinatal depression. Mindfulness and compassion-based...

DOI: 10.1186/s13063-019-3739-z (opens in new tab) Full text (opens in new tab) Mindfulness Humans Pregnancy complications Depression, postpartum +6

Sahaj Samadhi meditation vs a Health Enhancement Program in improving late-life depression severity and executive function: study protocol for a two-site, randomized controlled trial

Trials October 24, 2019 S. B. Peckham, Emily Ionson, Marouane Nassim et al.

BackgroundRecent estimates suggest an 11% prevalence of current late-life depression (LLD) and a lifetime prevalence of 16–20%. LLD leads to cognitive disturbance as well as a nearly two to three times increased risk of dementia. We conducted a recent randomized controlled trial (RCT) which demonstrated that Sahaj Samadhi meditation (SSM), an easy-to-implement, meditation-based augmentation...

Effects on stress reduction of a modified mindfulness-based cognitive therapy for family caregivers of those with dementia: study protocol for a randomized controlled trial.

Trials May 29, 2019 Patrick Pui Kin Kor, Justina Yat Wa Liu, Wai Tong Chien

Background: Caring for people with dementia (PWD) is stressful and poses many life challenges for the family caregivers. Interventions targeting the stress and psychological well-being of the caregivers have been proposed but the sustainable effects and efficacies of these interventions vary considerably. Mindfulness-based cognitive therapy (MBCT) has been shown to be effective at reducing...

Conducting a pilot randomized controlled trial of community-based mindfulness-based stress reduction versus usual care for moderate-to-severe migraine: protocol for the Mindfulness and Migraine Study (M&M).

Trials May 6, 2019 Alice Pressman, Heather Law, Robert Stahl et al.

Migraine is one of the most common neurological disorders in clinical practice and is a substantial cause of disability worldwide. Current approaches to therapy are primarily based on medication but are often limited by inadequate effectiveness and common side effects. Newer, more effective medications are expensive. Mindfulness-based stress reduction (MBSR), an 8-week classroom-based...

Cognitively-Based Compassion Training versus cancer health education to improve health-related quality of life in survivors of solid tumor cancers and their informal caregivers: study protocol for a randomized controlled pilot trial.

Trials April 29, 2019 Thaddeus W W Pace, Sally E Dodds, Alla Sikorskii et al.

Cancer survivors and their informal caregivers (family members, close friends) often experience significant impairments in health-related quality of life (HRQOL), including disruptions in psychological, physical, social, and spiritual well-being both during and after primary cancer treatment. The purpose of this in-progress pilot trial is to determine acceptability and preliminary efficacy (as...

DOI: 10.1186/s13063-019-3320-9 (opens in new tab) Full text (opens in new tab) Active control Cancer survivorship Compassion meditation Cortisol +2

Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial.

Trials January 11, 2019 Senthil Packiasabapathy, Ammu T Susheela, Ariel L Mueller et al.

Background: Cardiac surgical procedures are associated with postoperative neurological complications such as cognitive decline and delirium, which can complicate recovery and impair quality of life. Perioperative depression and anxiety may be associated with increased mortality after cardiac surgeries. Surgical prehabilitation is an emerging concept that includes preoperative interventions to...

Treatment effectiveness of a mindfulness-based inpatient group psychotherapy in adolescent substance use disorder - study protocol for a randomized controlled trial.

Trials December 27, 2018 Christiane Baldus, Laura Mokros, Anne Daubmann et al.

Background: Current treatments for adolescents with substance use disorder (SUD) have had only limited success. In recent years, research has underlined the role of self-regulatory processes and impulsivity in the development and maintenance of SUD in adolescents. Mindfulness has gained much attention due to its capacity to influence self-regulatory processes, particularly in adult populations....

Pilot study on increased adherence to physical activity on prescription (PAP) through mindfulness: study protocol

Trials October 17, 2018 Peter Nymberg, Eva Ekvall Hansson, Emelie Stenman et al. 9 citations

BACKGROUND: In the Swedish population aged between 50 and 64 years only 7.1% reach the recommended level of physical activity. Physical activity on prescription (PAP) has been used in Sweden since the beginning of the twenty-first century with moderate adherence of approximately 50%. Mindfulness seems to affect motivation to and satisfaction with physical activity. The aim is to test the...

Effect of low-dose ketamine on PerioperAtive depreSsive Symptoms in patients undergoing Intracranial tumOr resectioN (PASSION): study protocol for a randomized controlled trial.

Trials August 29, 2018 Yang Zhou, Yuming Peng, Jinghan Fang et al.

Perioperative depressive symptoms (PDS) are common mental comorbidities that influence clinical outcomes and prognosis. However, there is no rapid-acting treatment to address these symptoms during a limited hospital stay. This is a single-center, randomized, placebo-controlled, and double-blind trial. Randomization will be applied and stratified by the severity of PDS (moderate versus severe)....

DOI: 10.1186/s13063-018-2831-0 (opens in new tab) Full text (opens in new tab) Ketamine Depression symptom Perioperative Randomized controlled trial

Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

Trials May 11, 2018 Vera Salvo, Jean L. Kristeller, Jesus Montero-Marin et al.

Background: Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing...

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial.

Trials April 13, 2018 Lahiru Russell, Anna Ugalde, Donna Milne et al.

People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups...

Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials.

Trials April 2, 2018 Clara Strauss, Jenny Gu, Nikki Pitman et al.

Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management...