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BMJ Open

ISSN 2044-6055

50 papers in the library · 352 citations · publishing 2012-2026

Papers

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Synthesising evidence from decades of meditation-based research across populations, interventions, comparisons and outcomes: protocol for a meta-analytic database of randomised controlled trials via the MetaCIH Collaborative.

BMJ Open August 18, 2026

Synthesising evidence from decades of meditation-based research across populations, interventions, comparisons and outcomes: protocol for a meta-analytic database of randomised controlled trials via the MetaCIH Collaborative.

Acceptability and safety of two sequential doses of psilocybin in bipolar II depression: protocol for an open-label single-arm feasibility study.

BMJ Open July 13, 2026 Thomas D Meyer, Lauren N Vale, Maya Ibrahim et al.

Bipolar II disorder (BD-II) is characterised by hypomanic and depressive episodes with the latter tending to dominate the clinical course of the disorder, and they are often associated with suicidality. Despite available guideline-based recommendations for first-line pharmacological treatments, patient outcomes remain suboptimal, especially for those with chronic depression and suicidal...

Effects of open- versus closed-skill exercise combined with mindfulness training on inhibitory control in children with ADHD: protocol for a three-arm randomised controlled trial with fMRI

BMJ Open July 1, 2026 Wenwen Zhang, Guangyan Han, Haibin Guo et al.

INTRODUCTION: Impaired inhibitory control is a core neurocognitive deficit in children with attention deficit hyperactivity disorder (ADHD). Physical exercise and mindfulness training are each promising non-pharmacological approaches for ADHD; however, whether combining mindfulness with different exercise modalities, particularly team-based and individual-based open-skill exercise versus...

MDMA-assisted PTSD and Alcohol Therapy Trial (MPATHY): study protocol for a double-blind, randomised, controlled outpatient trial of MDMA-assisted integrated exposure-based therapy for comorbid post-traumatic stress disorder and alcohol use disorder

BMJ Open July 1, 2026 Kirsten Morley, Shalini Arunogiri, Katherine L. Mills et al.

INTRODUCTION: The treatment of comorbid post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) is significantly more challenging than the treatment of either disorder alone. While gold standard evidence-based treatments exist for this comorbidity, clinically significant improvements are only observed in approximately half of clinical trial participants. The use of adjunctive...

Development of the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET): a Delphi study.

BMJ Open May 11, 2026 Julia Colcott, Alexandre A. Guerin, Olivia Carter et al.

Despite growing interest in the therapeutic potential of 3,4-methylenedioxymethamphetamine (MDMA), no targeted measure to systematically assess side effects of MDMA-assisted psychotherapy (MDMA-AP) exists. Our aim was to develop an MDMA-Assisted Psychotherapy Side Effects Tool (M-SET) to capture side effects over the course of MDMA-AP. Informed by a systematic review and a review of other...

Negative effects of mindfulness-based cognitive therapy and cognitive behavioural analysis system of psychotherapy for patients with ‘difficult to treat’ depression: protocol for a systematic review and individual participant data meta-analysis

BMJ Open April 1, 2026 Maria Niemi, Johannes Michalak, Maria Velana et al.

Introduction Mindfulness-based interventions are widely used, yet concerns about potential negative effects—particularly those related to mindfulness meditation practice—have gained increasing attention. Individuals with difficult-to-treat depression (DTD) represent a population of particular relevance due to heightened vulnerability, but comparative evidence on clinically relevant negative...

Digital Intervention for Psychedelic Preparation (DIPP): protocol for a randomised controlled feasibility trial comparing meditation- and music-based programmes in healthy volunteers.

BMJ Open March 12, 2026 Rosalind McAlpine, Magdalena Jaglinska, Krisztina Jedlovszky et al.

Psychedelic-assisted therapy shows promise for treating various mental health conditions; however, its reliance on intensive psychological preparation limits its broader application. Digital health interventions have the potential to address this limitation by providing structured, accessible and scalable preparation solutions. This randomised controlled feasibility trial aims to evaluate the...

The Montreal model of ketamine-therapy for alcohol use disorder and comorbid treatment-resistant depression: protocol for a feasibility trial

BMJ Open March 1, 2026 Christina Mcanulty, Philippe Lavoie, Samuel Cyr et al.

BACKGROUND: Alcohol use disorder and treatment-resistant depression (TRD) often co-occur, presenting a major clinical challenge with limited effective treatments. However, ketamine produces rapid antidepressant effects and has shown promise in reducing alcohol use, and acceptance and commitment therapy (ACT) can be effective for both substance use and mood disorders. This study explores the...

Effects of low-dose esketamine on hypoxaemia during thoracoscopic non-tracheal intubation anaesthesia: protocol for a double-blind, randomised controlled trial.

BMJ Open January 27, 2026 Jing Tian, Mengchao Xu, Songjie Li et al.

Non-tracheal intubation anaesthesia for thoracoscopic surgery is associated with intraoperative hypoxaemia. Esketamine has both sedative and analgesic effects, which can increase lung compliance, reduce airway resistance and relax the respiratory smooth muscles. This study will investigate the effectiveness of low-dose esketamine in reducing the incidence of intraoperative hypoxaemia and other...

Efficacy and moderators of mindfulness-based cognitive therapy (MBCT) in 'Difficult to Treat' depression: protocol for a systematic review and individual participant data meta-analysis of randomised controlled trials.

BMJ Open December 8, 2025

Efficacy and moderators of mindfulness-based cognitive therapy (MBCT) in 'Difficult to Treat' depression: protocol for a systematic review and individual participant data meta-analysis of randomised controlled trials.

Randomised controlled trial of VR-based observation meditation with AI coaching ('Otti') for stress reduction in university students in the United States: study protocol.

BMJ Open October 23, 2025 Jiheun Hong, Christopher R Shelton, Hayoung Oh

Stress is a major health issue in contemporary society, and mindfulness-based approaches reduce stress and anxiety but face practical barriers to consistent practice; this protocol evaluates a Virtual Reality (VR)-based observation meditation programme with an artificial intelligence (AI) coach ('Otti') that delivers real-time empathic, tailored prompts to support present-focused attention and...

Experiences and user perceptions of virtual-reality-based mindfulness interventions: protocol for a systematic review and thematic synthesis

BMJ Open September 1, 2025 Ravi Shankar, Anjali Bundele, Amanda Yap et al. 1 citation

INTRODUCTION: Virtual reality (VR) technology is increasingly being explored as a medium for delivering mindfulness-based interventions. While studies have investigated the feasibility and efficacy of VR-based mindfulness interventions, there has been limited synthesis of user experiences and perceptions across diverse applications, hindering the iterative refinement of these technologies and...

Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks

BMJ Open August 1, 2025 Nicky J. Mehtani, B. Anderson, Irina Alexander et al.

INTRODUCTION: Methamphetamine use disorder (MeUD) is a debilitating condition with no FDA-approved pharmacotherapies that has been associated with poor neurological, psychiatric and cardiovascular outcomes, particularly among low-income populations. The use of methamphetamine also increases risks for sexually transmitted infections (STIs) by reducing behavioural inhibitions while enhancing...

S-ketamine versus placebo for cortical spreading depolarisation in severe acute brain injury (KETA-BID): protocol for a pilot, randomised, blinded clinical trial.

BMJ Open July 28, 2025 Trine Hjorslev Andreasen, Markus Harboe Olsen, Christian Gluud et al. 2 citations

Cortical spreading depolarisation (SD) is a pathological wave of depolarisation in the cortex. SDs occur frequently after severe acute brain injury, and SDs in clusters can contribute to secondary brain damage in patients with severe acute brain injury through hypoperfusion and upregulation of cerebral metabolism in vulnerable brain tissue. Ketamine appears to inhibit SDs both in vitro and in...

Online mindfulness interventions in the care of people with physical and mental health conditions: a scoping review.

BMJ Open July 18, 2025 Vjura Senthilnathan, Susan Zahir, Robert Simpson et al. 1 citation

With growing access to the internet, online mindfulness programmes have become more commonly used to manage physical and mental health conditions. This scoping review aims to determine the nature and extent of the literature, and key characteristics, of online mindfulness-based interventions (MBIs) for adults with physical or mental health conditions. A scoping review guided by the Joanna...

Inhalational nitrous oxide as a transdiagnostic approach for the treatment of suicidal ideation and suicidality in psychiatric inpatients: protocol for a double-blind randomised, controlled clinical single-centre trial.

BMJ Open July 16, 2025 Golo Kronenberg, Anna Bankwitz, Barbora Provaznikova et al.

Suicidal thoughts and behaviours are linked to a wide range of mental health conditions. New interest in the psychiatric benefits of nitrous oxide (N2O) has only recently emerged. The broad pharmacological effects of N2O are thought to be due in large part to N-methyl-d-aspartate antagonism and opioid effects. The purpose of this study protocol is to test whether inhalational N2O exerts rapid...

Effect of aerobic exercise combined with meditation on cognitive frailty: study protocol for a parallel group randomised controlled trial.

BMJ Open June 27, 2025 Sijia Xia, Feng Chen, Wenju Wang et al.

Cognitive frailty (CF) is a clinical syndrome characterised by the concurrent occurrence of physical frailty and cognitive impairment, excluding Alzheimer's disease and other forms of dementia. Recent studies have shown that combining aerobic exercise (AE) and meditation (ME) effectively enhances both physical and cognitive functions in individuals with CF. The study aims to determine whether...

Efficacy of a single low dose of esketamine for patients with irritable bowel syndrome: study protocol for a randomised controlled trial.

BMJ Open June 23, 2025 Zhe Sun, Lei Jiang, Yan Xing et al.

As a disorder of gut-brain interaction, irritable bowel syndrome (IBS) is a common reason for patient visits in primary and specialist care settings. IBS is associated with recurrent abdominal pain, altered bowel habit, resulting in alternating constipation and diarrhoea, bloating, without serious organic diseases. The bidirectional relationship between IBS and psychological factor is also...

Psilocybin-Assisted suppoRtive psychoTherapy IN the treatment of prolonged Grief (PARTING) trial: protocol for an open-label pilot trial for cancer-related bereavement

BMJ Open April 1, 2025 Vanessa L. Beesley, Tom Kennedy, Fiona Maccallum et al. 2 citations

Introduction Prolonged grief disorder (PGD) represents a substantial public health issue, especially in oncology settings where it affects up to 30% of bereaved carers. Current best-practice treatments are lengthy, and up to 50% of participants have persistent PGD. Building on encouraging recent research with psychedelic-assisted therapies, the Psilocybin-Assisted suppoRtive psychoTherapy IN...

Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial).

BMJ Open February 10, 2025 Kathryn Fletcher, Nadine Ezard, Krista J. Siefried et al. 1 citation

Methamphetamine use disorder is a significant public health concern. No pharmacological treatment options currently exist for methamphetamine use disorder, and psychotherapy is only moderately effective. Preliminary evidence suggests that ketamine-assisted psychotherapy produces sustained improvements in substance use and mental health symptomatology. In addition to direct antidepressant...

Using Artificial Intelligence-informed Experience-Based Co-Design (AI-EBCD) to create a virtual reality-based mindfulness application to reduce diabetes distress: protocol for a mixed-methods feasibility study

BMJ Open December 15, 2024 Angeliki Bogosian, Glenn Robert, Siobhan O'Connor et al.

Introduction People with type 2 diabetes can experience diabetes distress which can negatively affect health outcomes. Non-pharmacological interventions such as mindfulness can help address diabetes distress. However, face-to-face programmes can be constrained by cost, poor accessibility and lack of availability. Mobile apps for mindfulness may overcome these issues but evidence of their...

Virtual reality-guided mindfulness intervention to enhance psychosocial well-being in caregivers of end-stage kidney disease patients: protocol for a mixed-methods pilot randomised controlled trial

BMJ Open October 26, 2024 Amartya Mukhopadhyay, Ravi Shankar, Wei Zhen Hong et al.

Introduction Caregivers of patients with end-stage kidney disease (ESKD) face significant challenges that contribute to caregiver burden, negatively impacting their psychosocial well-being. Virtual-reality (VR)-guided mindfulness interventions have shown promise in reducing stress, anxiety and depression in various populations.Methods and analysis This pilot study aims to evaluate the efficacy...

Efficacy and safety of esketamine hydrochloride adjunct to sufentanil in non-surgical patients under mechanical ventilation in the ICU (SENSATION trial): protocol for a multicentre, single-blind, randomised controlled trial.

BMJ Open September 25, 2024 Yi Long, Donghuang Hong, Haibin Ni et al. 1 citation

Pain is common in patients receiving mechanical ventilation in the intensive care unit (ICU). Intravenous opioids are recommended as first-line therapy for pain management; however, opioids have adverse side effects. Based on low-quality evidence, low-dose ketamine is therefore recommended as an opioid adjunct to reduce opioid consumption. Esketamine is an alternative to ketamine with greater...

Comparative effect of different mindfulness-based intervention types and deliveries on depression in patients with breast cancer: a protocol for a systematic review and network meta-analysis.

BMJ Open August 7, 2024 Deqi Zhang, Wenxin Zhao, Lin Yuan et al. 1 citation

Breast cancer has become the most common cancer worldwide. Various types of mindfulness-based interventions (e.g., mindfulness-based cognitive therapy, mindfulness-based stress reduction) have been conducted in different delivery methods (including face to face and internet delivered) to help patients with breast cancer mitigate their depression. However, at present, there are no studies that...