BMJ Open
January 1, 2012
Adele Krusche, Eva Cyhlarova, Scott King et al.
120 citations
An online mindfulness course lasting about 6 weeks significantly reduced perceived stress in a sample of 100 self-referred adults (average age 48, 74% women). The reduction in stress was seen immediately after the course and remained stable at a 1-month follow-up. The size of the effect was similar to that of in-person mindfulness programs. People who started with higher stress levels reported doing more mindfulness practice, and more practice was linked to greater stress reduction. These results suggest that online mindfulness courses could broaden access to stress-reducing therapies.
BMJ Open
September 1, 2017
Elena Argento, Steffanie A. Strathdee, Kenneth W. Tupper et al.
60 citations
Among marginalised women in Vancouver, those who had ever used a psychedelic drug showed a 60% lower hazard of developing suicidal ideation or attempts over 54 months, after adjusting for other factors. Crystal methamphetamine use tripled the hazard, and childhood abuse more than tripled it. Nearly half of the 766 women had prior suicidality and were excluded; among the 290 without it at baseline, 11% developed suicidality during follow-up, an incidence of 4.42 per 100 person-years. The findings suggest naturalistic psychedelic use may have a protective association, while other illicit drug use and childhood trauma increase risk.
BMJ Open
November 1, 2016
Julieta Galante, Géraldine Dufour, Alice Benton et al.
46 citations
A pragmatic randomized controlled trial will test whether an 8-week mindfulness course, offered preventatively to University of Cambridge students free from active crises or severe mental illness, reduces psychological distress during exams and improves resilience to stress for at least one year, compared to usual mental health provision. At least 550 students will be randomly assigned to the course or to standard care. Psychological distress will be measured at baseline, after the intervention, during exams, and at one-year follow-up. The trial will also assess use of mental health services, exam performance, well-being, altruism, and coping. Results will be published in peer-reviewed journals.
BMJ Open
December 1, 2021
James Rucker, Hassan Jafari, Tim Mantingh et al.
23 citations
A randomized, placebo-controlled trial is testing the feasibility of psilocybin-assisted therapy for people with major depressive disorder who have not responded to at least two prior treatments. Up to 60 participants in London, UK receive either 25 mg psilocybin or a placebo in a single dosing session, along with psychological therapy. The primary outcomes are recruitment rates, dropout rates, and variance in depression scores measured by the Montgomery Asberg Depression Rating Scale at 3 and 6 weeks. The trial also collects neuroimaging and omics data and offers an open-label extension dose of psilocybin.
BMJ Open
October 1, 2022
Mathias Ebbesen Jensen, Dea Siggaard Stenbæk, Tobias Søgaard Juul et al.
21 citations
A planned clinical trial will test whether psilocybin-assisted therapy, compared to a placebo, reduces heavy drinking in people with alcohol use disorder. Ninety treatment-seeking adults aged 20–70 will be randomly assigned to receive either psilocybin or placebo alongside psychological support. The main outcome is the change in percentage of heavy drinking days from baseline to 12 weeks after dosing. Secondary outcomes include total alcohol consumption, a blood biomarker for alcohol, the active drug metabolite in blood, the subjective drug experience, and brain responses to alcohol cues measured with functional MRI one week after dosing. The trial is registered and has ethical approval.
BMJ Open
July 4, 2019
Charlotte Todd, Roxanne Cooksey, Helen Davies et al.
21 citations
A mixed-methods evaluation compared the impact of two different mindfulness approaches on stress, anxiety, and depression in school teachers. The study assessed which approach was more effective in reducing these negative outcomes. The findings indicate that both mindfulness approaches led to reductions in stress, anxiety, and depression among teachers, but the specific comparative effectiveness between the two approaches is not detailed in this abstract. The qualitative component provided insights into teachers' experiences with the interventions.
BMJ Open
May 1, 2023
Alan K. Davis, Adam W. Levin, Paul Nagib et al.
19 citations
Psilocybin-assisted therapy may help treat post-traumatic stress disorder (PTSD), which current treatments often fail to relieve, especially in U.S. military veterans. This open-label pilot study will test two psilocybin doses (15 mg and 25 mg) combined with psychotherapy in 15 veterans with severe, treatment-resistant PTSD. The primary safety outcome tracks adverse events and suicidal ideation; the primary PTSD outcome uses the Clinician Administered PTSD Scale-5. Follow-up continues for 6 months after the second session. Results will be published in a peer-reviewed journal.
BMJ Open
March 1, 2024
Charlie Song-Smith, Edward Jacobs, James Rucker et al.
9 citations
Most UK medical students (83%) are aware of psychedelic research and only 3% are not interested in learning more, yet only 17% feel well-educated on the topic. Students' harm assessments of psychedelics closely match experts', but teaching on psychedelics is rare in their curriculum. Time in medical school does not correlate with more knowledge about psychedelics. On average, students strongly support changing the legal status of psychedelics to enable further clinical research. Greater knowledge, lower perceived harm, more years in medical school, and lower perceived effectiveness of non-pharmacological mental health treatments are associated with stronger support for legal change.
BMJ Open
November 23, 2023
Adam P. Wagner, Julieta Galante, Géraldine Dufour et al.
7 citations
Providing university students with a mindfulness-based intervention to reduce psychological distress is not cost-effective compared with usual support, according to an economic evaluation of a pragmatic randomised controlled trial. The intervention was more costly and produced no significant improvement in quality-adjusted life years or psychological distress outcomes, suggesting it does not represent good value for money.
BMJ Open
September 25, 2023
Cen Chen, Qingfeng Wei, Jiajia Zhu et al.
7 citations
A planned trial will test whether a low dose of the anesthetic esketamine, given before and during surgery, reduces depressive symptoms in women with breast cancer who are undergoing radical mastectomy. The study will randomly assign 108 women with mild-to-severe depression to receive either esketamine or a saline placebo. The main outcome is the proportion of patients whose depressive symptoms improve by the third day after surgery. The study also will measure changes in a brain protein called brain-derived neurotrophic factor and in resting-state brain connectivity, aiming to uncover how esketamine might work.
BMJ Open
May 1, 2024
Ben Beaglehole, Richard Porter, Katie Douglas et al.
5 citations
A randomized controlled trial will test the feasibility of adding behavioral activation therapy (BAT) to oral ketamine for treatment-resistant major depressive disorder. The study aims to recruit 60 adults aged 18–65 years, randomizing them to eight weeks of oral ketamine with BAT or oral ketamine alone. Feasibility will be measured by attendance, acceptability, and retention. The primary efficacy outcome is the Montgomery-Asberg Depression Rating Scale, assessed weekly during treatment and fortnightly during 12 weeks of follow-up. For a definitive trial to be recommended, the study must meet recruitment targets and show a greater than 20% reduction in relapse rates favoring the combined treatment arm.
BMJ Open
November 26, 2022
Nick Glozier, Ben Colagiuri, Dean J Wright
3 citations
Mental health professionals' attitudes toward a trial of MDMA-assisted psychotherapy did not differ overall from their attitudes toward a neutrally labeled pharmacotherapy trial. Psychiatrists were less willing to recommend participation in the MDMA-AP trial than in the control trial. Psychologists and researchers showed no differences. More experienced professionals had greater concern and stronger objections to the MDMA-AP trial than less experienced ones. The findings suggest that certain mental health professionals, particularly experienced psychiatrists, may be hesitant about MDMA-AP, which could pose barriers to its research and implementation.
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 brain cell activity that occurs frequently after severe acute brain injury and can worsen damage by reducing blood flow and increasing energy demand. Ketamine appears to inhibit SDs in laboratory and patient studies. The KETA-BID trial is a randomized, blinded feasibility and pilot study testing S-ketamine for SDs in adults undergoing surgery for traumatic brain injury, aneurysmal subarachnoid hemorrhage, or spontaneous intracerebral hemorrhage. Participants who develop SD clusters receive either continuous S-ketamine or placebo, with dosing adjusted based on SD occurrence. The primary outcome is SDs per hour after randomization. The trial will provide insight into SD and ketamine's clinical effects, potentially offering a new treatment.
BMJ Open
April 1, 2025
Vanessa L. Beesley, Tom Kennedy, Fiona Maccallum et al.
2 citations
Prolonged grief disorder (PGD) affects up to 30% of bereaved carers in oncology settings, and current treatments fail up to half of participants. The PARTING trial is the first to test psilocybin-assisted psychotherapy for cancer-related PGD. In this open-label pilot, about 15 participants receive a 25 mg dose of psilocybin with supportive guidance, plus preparation and integration sessions delivered by a psychologist and a nurse or Indigenous Therapist. Feasibility, safety, and acceptability are assessed through recruitment rates, adverse events, physiological measures, and qualitative interviews. Quantitative measures include grief severity, depression, anxiety, and quality of life over a 12-month follow-up.
BMJ Open
July 5, 2024
Michael Schlegelmilch, Amy C Plint, Nicholas Barrowman et al.
2 citations
A single intravenous dose of ketamine may rapidly reduce suicidal ideation in adults, but it has not been tested in adolescents. This pilot trial aims to determine whether studying ketamine for suicidal ideation in a pediatric emergency department is feasible. Twenty adolescents will be randomly assigned to receive either 0.5 mg/kg of intravenous ketamine or a saline placebo over 40 minutes. Suicidal ideation severity will be measured at several time points up to seven days. The main feasibility outcome is the proportion of eligible patients who complete the study protocol. The trial will also pilot three suicidal ideation severity tools and explore the intervention's efficacy, safety, and tolerability.
BMJ Open
September 1, 2025
Ravi Shankar, Anjali Bundele, Amanda Yap et al.
1 citation
This systematic review protocol describes a planned synthesis of qualitative research on user experiences with virtual reality (VR)-based mindfulness interventions. The review will search multiple databases for studies reporting adult participants' perceptions, attitudes, and opinions about VR mindfulness. Two independent reviewers will screen studies, extract data, and assess quality using the Critical Appraisal Skills Programme checklist. Thematic synthesis will analyze qualitative findings, and confidence in the results will be evaluated with the GRADE-CERQual approach. The work aims to identify design improvements and implementation strategies for VR mindfulness interventions in real-world settings.
BMJ Open
July 18, 2025
Vjura Senthilnathan, Susan Zahir, Robert Simpson et al.
1 citation
Online mindfulness programs are increasingly used to manage health conditions. This scoping review of 84 studies found that online mindfulness-based interventions have been studied for many physical and mental health conditions, with 63 studies focused on physical health. Mindfulness-based cognitive therapy was the most common type, assessed in 33 studies. Interventions typically lasted 8 weeks, were led by therapists or instructors, and delivered via web or videoconferencing. Content generally followed standard mindfulness programs, sometimes adding psychoeducation or disease management. Many studies did not report tailoring interventions to participants, and reporting of intervention details was inconsistent. The review suggests some evidence for online mindfulness programs but notes that intervention components remain unclear.
BMJ Open
February 10, 2025
Kathryn Fletcher, Nadine Ezard, Krista J. Siefried et al.
1 citation
A pilot study will test the safety and feasibility of combining subanaesthetic ketamine with cognitive behavioural therapy for adults with methamphetamine use disorder. Twenty participants seeking to reduce or stop methamphetamine use will receive three subcutaneous ketamine doses (0.75 to 0.9 mg/kg) at weekly intervals and four therapy sessions over four weeks. The study will measure recruitment time, eligibility rates, treatment completion, retention, and acceptability over eight weeks, and explore changes in methamphetamine use, cravings, withdrawal, quality of life, and treatment satisfaction over 24 weeks. No pharmacological treatments currently exist for this condition, and psychotherapy alone is only moderately effective.
BMJ Open
September 25, 2024
Yi Long, Donghuang Hong, Haibin Ni et al.
1 citation
Esketamine as an adjunct to sufentanil may reduce opioid consumption in non-surgical patients receiving mechanical ventilation in the ICU. This ongoing multicenter, single-blind, randomized controlled trial in six ICUs in China will assign 132 patients to either standard care (sufentanil alone) or an esketamine infusion at 0.2 mg/kg/hour plus sufentanil. The primary outcome is mean hourly sufentanil consumption. The trial aims to provide evidence for esketamine's efficacy and safety, addressing a gap in knowledge for this patient population.
BMJ Open
August 7, 2024
Deqi Zhang, Wenxin Zhao, Lin Yuan et al.
1 citation
Breast cancer is now the most common cancer worldwide. Mindfulness-based interventions, such as mindfulness-based cognitive therapy and mindfulness-based stress reduction, have been used in various delivery methods, including face-to-face and internet-delivered, to help patients with breast cancer reduce depression. No study has yet compared the effectiveness of all these types and deliveries. This protocol describes a planned systematic review and network meta-analysis to assess their effectiveness. The review will search seven electronic databases for randomized controlled trials from inception to December 2023. Two reviewers will assess risk of bias. The results will be published in peer-reviewed journals.
BMJ Open
July 13, 2026
Thomas D Meyer, Lauren N Vale, Maya Ibrahim et al.
A protocol describes an upcoming feasibility study testing psilocybin-assisted therapy in 10 outpatients with bipolar II disorder who have mild to moderate passive suicidal thoughts. Participants may receive two oral doses of 25 mg psilocybin about four weeks apart, combined with a structured mindfulness-based cognitive-behavioral therapy protocol. The study aims to assess the acceptability and safety of this approach, measuring changes in suicidality and depressive symptoms, and to gather preliminary data for a future randomized trial. Individuals with bipolar disorder and suicidality have typically been excluded from psilocybin trials due to safety concerns.
BMJ Open
July 1, 2026
Kirsten Morley, S Arunogiri, Katherine L. Mills et al.
Combining MDMA with an integrated exposure-based therapy may improve outcomes for people with both post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD), a comorbidity where standard treatments help only about half of patients. This double-blind trial will randomly assign 100 participants to receive either MDMA (80–160 mg) or an active control (niacin 250 mg) alongside 12 sessions of Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE). The primary PTSD outcome is the clinician-administered PTSD Scale for DSM-5; the primary drinking outcome is heavy drinking days per week, validated by phosphatidylethanol. Secondary measures include depression, sleep disturbances, adverse events, and cost-effectiveness. Results will provide first data on safety, efficacy, and cost-effectiveness of MDMA-augmented therapy for this comorbidity.
BMJ Open
May 11, 2026
Julia Colcott, Alexandre A. Guerin, Olivia Carter et al.
A new tool, the MDMA-Assisted Psychotherapy Side Effects Tool (M-SET), was developed to systematically capture side effects during MDMA-assisted psychotherapy. Experts in MDMA-AP and neuropsychopharmacology participated in a two-round online Delphi process to refine a list of 165 items across four questionnaires covering screening, baseline, medication session days, and follow-up. The tool aims to improve safety monitoring and build a more robust evidence base on the tolerability of MDMA-AP for research and clinical use.
BMJ Open
March 12, 2026
Rosalind McAlpine, Magdalena Jaglinska, Krisztina Jedlovszky et al.
A 21-day mobile-accessible programme called the Digital Intervention for Psychedelic Preparation (DIPP) is being tested for feasibility and preliminary efficacy in a randomised controlled trial. The study will recruit 40 non-treatment-seeking adults without a clinical diagnosis, randomly assigning them to either a guided meditation with music condition or a music-only condition. After the digital intervention, all participants will attend an in-person supervised psilocybin session with a standardised 25 mg dose. Primary outcomes include recruitment efficiency, retention, and adherence; secondary outcomes assess preparedness, quality of the psychedelic experience, and wellbeing, with follow-ups up to 9 months. The trial is registered as NCT06815653.
BMJ Open
March 1, 2026
Christina Mcanulty, Philippe Lavoie, Samuel Cyr et al.
A new treatment combining ketamine infusions with acceptance and commitment therapy (ACT) may be feasible for people who have both alcohol use disorder and treatment-resistant depression. In an open-label trial at a Montreal hospital, 30 participants will receive six ketamine infusions plus eight weekly therapy sessions, either in person or online. The study primarily tests whether the combined approach is practical and acceptable by measuring completion rates, safety, and data quality. Exploratory measures will track changes in depressive symptoms, alcohol use, and quality of life. Some participants will also be interviewed about their experiences.