BMJ Open
January 27, 2026
Jing Tian, Mengchao Xu, Songjie Li et al.
Low-dose esketamine may reduce the incidence of intraoperative hypoxaemia during non-intubation thoracoscopic surgery. This randomized controlled trial will assign patients to receive either esketamine or a placebo (normal saline). The main outcomes are the occurrence of hypoxaemia (oxygen saturation ≤90% for at least 10 seconds) and the time until it appears. Secondary outcomes include hypercapnia, inflammatory markers, pain scores, recovery times, and complications. The trial is registered and approved by an ethics committee.
BMJ Open
August 1, 2025
Nicky J. Mehtani, B. Anderson, Irina Alexander et al.
Methamphetamine use disorder (MeUD) has no FDA-approved pharmacotherapies and is linked to poor neurological, psychiatric, and cardiovascular outcomes, especially among low-income populations, while also increasing risks for sexually transmitted infections. The Ketamine-Assisted Recovery (KARE) trial is an open-label pilot study enrolling 12 to 24 Medicaid- or Medicare-insured adults with moderate-to-severe MeUD and HIV risk factors. Participants will receive three intramuscular ketamine sessions (0.50-0.75 mg/kg) combined with seven motivational enhancement therapy sessions over five weeks. The study will assess feasibility, acceptability, tolerability, safety, and potential mechanisms such as psychological flexibility, laying groundwork for future randomized trials.
BMJ Open
June 27, 2025
Sijia Xia, Feng Chen, Wenju Wang et al.
This registered clinical trial protocol describes a four-arm, assessor-blind randomized controlled trial that will test whether combining aerobic exercise with meditation produces greater improvements in physical and cognitive function for people with cognitive frailty than either practice alone. Cognitive frailty is the simultaneous presence of physical frailty and cognitive impairment without dementia. One hundred forty qualified participants will be randomly assigned to aerobic exercise, meditation, combined aerobic exercise and meditation, or a health education control group for 12 weeks. Primary outcome is the Edmonton Frailty Scale; secondary outcomes include cognitive tests, physical performance, subjective experiences, brain MRI measures, and blood biomarkers. Assessments occur at baseline and after the intervention.
BMJ Open
June 23, 2025
Zhe Sun, Lei Jiang, Yan Xing et al.
Irritable bowel syndrome (IBS) is a common disorder of gut-brain interaction involving recurrent abdominal pain and altered bowel habits. Conventional treatments are often unsatisfactory. This trial hypothesizes that a single low dose of esketamine, which has rapid antidepressant effects, may alleviate IBS symptoms. The study is a single-centre, randomized, double-blind, placebo-controlled trial enrolling 92 patients per group across three severity levels. The primary outcome is the IBS Severity Scoring System measured at baseline and up to six weeks after colonoscopy. Secondary outcomes include quality of life, stool form, anxiety, depression, and somatic symptoms. The protocol is approved and registered.
BMJ Open
December 8, 2025
Mindfulness-based cognitive therapy (MBCT) may help people with depression that is difficult to treat. This protocol describes a planned systematic review and individual participant data meta-analysis of randomised controlled trials to assess MBCT's efficacy and identify which patient characteristics predict better outcomes. The analysis will combine raw data from multiple trials to determine whether MBCT reduces depressive symptoms and relapse in this challenging population, and to explore moderators such as depression severity, number of previous episodes, and childhood adversity. The results should clarify for whom MBCT works best and inform clinical decision-making for treatment-resistant depression.
BMJ Open
October 23, 2025
Jiheun Hong, Christopher R Shelton, Hayoung Oh
A planned randomized controlled trial will test whether a single 15-minute session of Virtual Reality-based observation meditation with an AI coach ('Otti') can reduce perceived stress and physiological arousal in university students after a standardized stressor. Thirty-four students will be randomly assigned to either the VR meditation or a no-treatment leisure control. Primary outcomes include self-reported stress (PSS-10), emotional state (DASS-21, STAI), heart rate and heart rate variability, and user satisfaction. The protocol describes a 30-minute laboratory visit with pre- and post-intervention surveys and physiological recording. The study has received IRB approval and is registered at ClinicalTrials.gov (NCT06704282).
BMJ Open
July 16, 2025
Golo Kronenberg, Anna Bankwitz, Barbora Provaznikova et al.
Nitrous oxide (N2O) may offer rapid antisuicidal effects across mental health conditions, with its pharmacological action thought to involve NMDA antagonism and opioid effects. This protocol describes a single-centre pilot study of 85 psychiatric inpatients. In a double-blind, randomized, placebo-controlled design, the first 45-minute inhalation session delivers either 50% N2O with 50% oxygen or 50% oxygen plus air. Suicidal ideation is measured by the Beck Scale for Suicidal Ideation before and after inhalation. A second N2O inhalation one week later ensures all participants receive active treatment. A nested biomarker substudy using hair, blood, and EEG will explore mechanisms and prediction.
BMJ Open
April 1, 2024
Shampa Maji, Debadatta Mohapatra, M. Jena et al.
Adding dextromethorphan to ongoing SSRI treatment may improve outcomes for major depressive disorder. A randomized, double-blind, placebo-controlled trial will assign patients to receive either 30 mg dextromethorphan or placebo once daily for 8 weeks alongside their SSRI. The primary outcome is change in depression severity measured by the Montgomery-Åsberg Depression Rating Scale; secondary outcomes include response and remission rates, clinical global impression, and serum biomarkers. The trial aims to address therapeutic latency, lack of efficacy, and adverse drug reactions in current antidepressant therapies.
BMJ Open
August 25, 2022
Peter J Bayley, R Jay Schulz-Heik, Julia S Tang et al.
A randomized non-inferiority trial compared Sudarshan Kriya Yoga (SKY), a breathing-based group program, with individual cognitive processing therapy (CPT) for post-traumatic stress disorder (PTSD) in 85 veterans (mean age 56.9, 61% white, 75 men). At 6 weeks, PTSD symptoms (measured by the PCL-C) decreased by 5.6 points with SKY and 6.8 points with CPT. The difference of -1.2 points fell within the prespecified non-inferiority margin of 10 points, indicating SKY was not inferior to CPT. SKY remained non-inferior at 1-month and 1-year follow-ups for PTSD symptoms, but was inferior to CPT on depression and affect measures at 1 year. Dropout rates were similar (27% SKY, 34% CPT). The authors suggest SKY merits further consideration as a PTSD treatment.
BMJ Open
November 5, 2020
Tatjana Ewais, Jake Begun, Maura Kenny et al.
Youth with inflammatory bowel disease and depression who completed an adapted mindfulness-based cognitive therapy group programme described the experience as healing and transformative. Four themes emerged: connectedness and shared understanding, growing in wisdom, therapeutic alliance, and barriers to mindfulness practice. Participants perceived peer connection as essential for learning mindfulness skills, which in turn strengthened that connection. Barriers included fatigue, depression, time, and travel constraints. The findings help interpret the results of the larger randomized controlled trial and inform future MBCT studies in this cohort.
BMJ Open
April 3, 2019
Danielle C Mathersul, Julia S Tang, R Jay Schulz-Heik et al.
A protocol describes an ongoing non-inferiority randomized controlled trial comparing a breathing meditation intervention (Sudarshan Kriya Yoga) to cognitive processing therapy for PTSD among veterans. The trial uses blinded assessors and measures PTSD symptoms via the PTSD Checklist-Civilian Version, along with clinical, self-report, experimental, and physiological outcomes across four symptom clusters. Analyses will include both intent-to-treat and per-protocol procedures. This is the first such trial of SKY versus CPT for veterans with PTSD. Results will inform future efficacy studies and formal recommendations for complementary interventions.
BMJ Open
September 24, 2018
Julie Lynch, Lucia Prihodova, Pádraic J Dunne et al.
Emergency department staff described high work pressure and perceived stress, but those who attended a mantra meditation programme reported benefits including increased attention and awareness, improved emotion regulation, new coping mechanisms, relaxation, and better sleep. Conflicting attitudes and barriers such as scheduling, practice length, and individual differences also emerged. Staff voiced a need for a workplace well-being programme. The findings suggest mantra meditation might be a viable tool to improve attention, emotion regulation, and stress coping, potentially impacting workplace well-being, patient safety, and care quality. Organizational support was seen as integral to embedding such a programme.
BMJ Open
January 1, 2018
Martin Lamothe, P. McDuff, Yves D Pastore et al.
A mindfulness-based stress reduction (MBSR) programme was feasible and acceptable in two proof-of-concept studies with students and healthcare professionals. Completing the 8-week programme was associated with improvements in perspective taking, identifying one's own emotions, and emotional acceptance, with a median effect size of Cohen's d = 0.92. Effects were maintained at 3-month follow-up in the professional group for identifying one's own emotions, emotional acceptance, expressive suppression, and emotion recognition. No significant signal was found for identifying others' emotions or empathic concern. The authors argue these results justify moving toward efficacy trials using these outcomes.
BMJ Open
May 1, 2015
L. Leung, Han Han, Mary I Martin et al.
This systematic review and meta-analysis protocol describes a planned evaluation of mindfulness-based stress reduction (MBSR) for chronic non-cancer pain (CNCP). Chronic pain affects up to 50% of the global population and is inadequately managed by opioids and other invasive interventions. Previous reviews have included heterogeneous studies. The authors aim to provide an updated, critical assessment by including only randomized controlled trials that use MBSR as the main intervention for non-somatisation CNCP. Outcome measures will be pain scores and disability scales. Data will be meta-analyzed using a random effects model, with effect size expressed as standardized mean difference and 95% confidence intervals.
BMJ Open
November 1, 2013
Adele Krusche, Eva Cyhlarova, J Mark G Williams
An online mindfulness course, completed at a self-directed pace over at least 4 weeks, significantly reduced perceived stress, anxiety, and depression in 273 self-referred adults. Improvements were seen immediately after the course and continued to increase at a 1-month follow-up, with effect sizes comparable to those of face-to-face mindfulness programs and cognitive behavioral therapy. The amount of meditation practice reported did affect outcomes when controlling for baseline severity. The study lacked a control group, so future research is needed to confirm the findings for different populations.