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ISSN 1745-6215

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

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Adolescents and carers using mindfulness Therapy To END depression (ATTEND): study protocol for a parallel randomised controlled superiority trial of Mindfulness for Adolescents and Carers (MAC) for depression among young people aged 15 to 18 years old with an embedded economic evaluation

Trials October 23, 2026 Tamsin Ford, Rachel Childs, Rachel Hayes et al.

Abstract: Background: Mindfulness-based cognitive therapy (MBCT) is a group intervention recommended by NICE for adults who have experienced recurrent depression but is untested for adolescents. MBCT aims to teach people to recognise early indicators of depression, to avoid repetitive thinking patterns that make relapse more likely, and to respond to stressors in ways that protect mental...

AI-assisted characterization of psychedelic clinical trials from ClinicalTrials.gov

Trials October 14, 2026 Luca Pani, Fabio Tascedda

Abstract: Background: The registry record of psychedelic and related rapid-acting compounds is large, heterogeneous and laborious to synthesize by hand. We tested whether a large language model (LLM) with live access to the ClinicalTrials.gov application programming interface (API) could produce a timely, structured and reproducible characterization of this landscape. Methods: Cross-sectional...

Effect of brief online mindfulness-based cognitive therapy in patients with digital replantation: a study protocol for a randomized controlled trial.

Trials April 13, 2026 Fanshan Huang, Weiwei Wang, Xin Miao et al.

Traumatic amputations are common traumatic injuries that require digital replantation to restore the form, function, and sensation of the hand. The post-surgical survival of replanted digits is influenced by multiple factors, including psychological factors such as posttraumatic stress disorder (PTSD), anxiety, and depression. Mindfulness-based cognitive therapy (MBCT) is considered a potential...

DOI: 10.1186/s13063-026-09697-1 (opens in new tab) Full text (opens in new tab) PTSD Digital replantation Mindfulness-based cognitive therapy Randomized controlled trial +1

Effects of low-dose esketamine on hypoxemia during gastroscopy in patients with moderate-to-high risk obstructive sleep apnea: protocol for a prospective, randomized, controlled trial.

Trials September 26, 2025 Xin-Ming Li, Si-Qi Hao, Xiu-Ru Qi et al. 2 citations

Propofol sedation in patients with Obstructive Sleep Apnea (OSA) frequently induces hypoxemia, posing significant clinical risks. Esketamine, an N-Methyl-D-Aspartate (NMDA) receptor antagonist, may reduce propofol requirements while preserving respiratory stability, but its efficacy in OSA patients remains unproven. At the studied dose (0.25 mg/kg), esketamine's potential side effects...

DOI: 10.1186/s13063-025-09098-w (opens in new tab) Full text (opens in new tab) Obstructive sleep apnea Painless gastroscopy Procedural sedation Esketamine-propofol +3

Co-Boost: boosting and guiding neuroplasticity by combining ketamine with neurofeedback-assisted learning—towards an individualised and integrated pharmaco-psychotherapy for cocaine addiction: study protocol for a randomised, placebo-controlled, double-blind, parallel-group, single-centre trial

Trials September 25, 2025 Anna Trippel, Ladina P Gubser, Etna Engeli et al. 1 citation

BACKGROUND: Cocaine is the most frequently used stimulant worldwide, with increasing consumption rates in Europe. Cocaine use is associated with great harm to individuals and society. As of today, psychotherapeutic interventions for cocaine use disorder (CUD) demonstrate only modest effect sizes, and no pharmacotherapy has been approved due to gaps in understanding the disease. However, a novel...

DOI: 10.1186/s13063-025-08982-9 (opens in new tab) Ketamine Neuroplasticity Boosting machine learning Protocol science +5

Brain Injury and Ketamine study (BIKe): a prospective, randomized controlled double blind clinical trial to study the effects of ketamine on therapy intensity level and intracranial pressure in severe traumatic brain injury patients.

Trials May 28, 2025 Veerle De Sloovere, Liese Mebis, Pieter Wouters et al. 9 citations

In severe traumatic brain injury (TBI), sedatives are often used to control intracranial pressure (ICP), to reduce brain metabolism, to allow for other treatments such as mechanical ventilation or targeted temperature management, or to control paroxysmal sympathetic hyperactivity. Prolonged sedation is often necessary. The most commonly used sedatives in TBI are propofol and midazolam, often in...

DOI: 10.1186/s13063-025-08835-5 (opens in new tab) Full text (opens in new tab) Analgesics Brain injury Central nervous system Cranio-cerebral trauma +7

Fentanyl or esketamine for traumatic pain (FORE-PAIN) trial: study protocol for a double-blind multi-arm randomized non-inferiority trial.

Trials May 26, 2025 Midas N de Grunt, Nurseda Risvanoglu, Johannes A Siegers et al. 1 citation

Although fentanyl and esketamine, administered intravenously (IV) or intranasally (IN), are standard of care for treatment of acute traumatic pain in the prehospital setting in the Netherlands, comparative evidence regarding their efficacy and safety is lacking. Therefore, this study aims to assess the efficacy and safety of fentanyl IN, esketamine IV and esketamine IN as compared to fentanyl...

A brief online mindfulness intervention: study protocol for Indonesian undergraduate students, a randomized controlled trial.

Trials May 13, 2025 Ka Yan, Nessa Ikani, Cleoputri Yusainy et al. 1 citation

Elevated levels of stress, anxiety, and depression persist among undergraduate students in Eastern countries, including Indonesia. Access to mental healthcare resources, however, remains difficult and costly for most young people. Furthermore, there is a strong tendency to avoid seeking professional help. The primary aim of this study is to investigate the effects of a brief 14-day online...

Adjunctive ketamine vs. buprenorphine in co-occurring major depressive disorder and opioid use disorder: a randomized, double-blind clinical trial assessing anxiety symptom severity and craving intensity.

Trials April 17, 2025 Arash Mansoori, Amir Bazrafshan, Jamshid Ahmadi et al. 4 citations

The concomitant presence of major depressive disorder (MDD) and opioid use disorder (OUD) poses a formidable clinical challenge, warranting effective interventions that address both psychiatric and addictive components. This study sought to compare the efficacy of adjunctive ketamine and buprenorphine in mitigating anxiety symptom severity and craving intensity in individuals with co-occurring...

Effect of esketamine on postoperative quality of recovery in patients undergoing arthroscopic rotator cuff repair: protocol for a prospective, randomized, double-blind study.

Trials December 4, 2024 Qirong Sun, Jiao Luo, Shijia Zhang et al. 1 citation

The utilization of shoulder arthroscopic surgery has progressively increased as a prevalent surgical approach for the treatment and repair of rotator cuff injury in clinical practice. However, early postoperative pain and neurological dysfunction remain significant factors that impact patients' postoperative recovery. Esketamine, an NMDA receptor antagonist, effectively reduces opioid...

DOI: 10.1186/s13063-024-08600-0 (opens in new tab) Full text (opens in new tab) Esketamine Controlled hypotension Early recovery quality Anesthesia anaesthesia +7

LSDDEP2: study protocol for a randomised, double-dummy, triple-blind, active placebo-controlled, parallel groups trial of LSD microdosing in patients with major depressive disorder.

Trials August 24, 2024 Dimitri Daldegan-Bueno, Carina Joy Donegan, Anna Forsyth et al. 14 citations

Major depressive disorder (MDD) poses a significant global health burden with available treatments limited by inconsistent efficacy and notable side effects. Classic psychedelics, including lysergic acid diethylamide (LSD), have garnered attention for their potential in treating psychiatric disorders. Microdosing, the repeated consumption of sub-hallucinogenic doses of psychedelics, has emerged...

Engaging Mood Brain Circuits with Psilocybin (EMBRACE): a study protocol for a randomized, placebo-controlled and delayed-start, neuroimaging trial in depression.

Trials July 3, 2024 Joshua M. Poulin, Gregory E. Bigford, Krista L. Lanctôt et al. 3 citations

Major depressive disorder (MDD) is a leading cause of disability worldwide across domains of health and cognition, affecting overall quality of life. Approximately one third of individuals with depression do not fully respond to treatments (e.g., conventional antidepressants, psychotherapy) and alternative strategies are needed. Recent early phase trials suggest psilocybin may be a safe and...

Effect of MDMA-assisted therapy on mood and anxiety symptoms in advanced-stage cancer (EMMAC): study protocol for a double-blind, randomised controlled trial.

Trials May 21, 2024 Chiranth Bhagavan, Paul Glue, Will Evans et al. 7 citations

Symptoms of anxiety and depression are common in patients with terminal illness and multiple challenges exist with timely and effective care in this population. Several centres have reported that one dose of the serotonergic psychedelic psilocybin, combined with therapeutic support, improves these symptoms for up to 6 months in this patient group. Drawing upon related therapeutic mechanisms,...

Mindfulness-based intervention for hypertension patients with depression and/or anxiety in the community: a randomized controlled trial.

Trials May 2, 2024 Hailiang Zhang, Xiangrong Zhang, Xiaomei Jiang et al. 19 citations

To evaluate mindfulness-based intervention for hypertension with depression and/or anxiety. 10-week mindfulness-based intervention, including health education for hypertension, exclusively for the control group, was administered to the intervention group to assist sixty hypertension patients with depression/anxiety. Among them, the intervention group comprised 8 men and 22 women, with a mean...

Effectiveness and cost-effectiveness of an electronic mindfulness-based intervention to improve maternal mental health in the peripartum: study protocol for a randomised controlled trial.

Trials November 23, 2023 Grace Branjerdporn, Kerri Gillespie, Elizabeth Martin et al. 1 citation

Perinatal women are highly vulnerable to developing mental health issues and particularly susceptible to a recurrence of psychiatric illness. Poor mental health during the perinatal period can have long-term impacts on the physical and psychiatric health of both mother and child. A potentially useful strategy to improve women's mental health is through a mobile application teaching mindfulness,...

Effect of music breathing, a program based on mindful breathing and music listening therapy for promoting sense of coherence in young people: study protocol for a randomized controlled trial.

Trials October 12, 2023 Winnie Lai-Sheung Cheng, Anson Chui-Yan Tang, Mark Cheuk-Man Tsang et al. 4 citations

The negative impacts of the COVID-19 pandemic on public health have affected people socially, psychologically, and physically. Young people particularly are having to adjust many aspects of their personal lives: including transitions to work, college, and independent living. Personal resources are important in mitigating stress and improve mental well-being during pandemic. Sense of...

DOI: 10.1186/s13063-023-07645-x (opens in new tab) Full text (opens in new tab) Mindfulness Mental well-being Music therapy Randomized controlled trial +2

MITIG.RA: study protocol of a tailored psychological intervention for managing fatigue in rheumatoid arthritis randomized controlled trial.

Trials October 6, 2023 Cátia Duarte, Ruben L F Spilker, Cláudia Paiva et al. 2 citations

Despite remarkable medical advances in the treatment of rheumatoid arthritis (RA), a subset of patients fails to achieve complete clinical remission, as the Patient Global Assessment (PGA) of disease activity remains above 1, even after the inflammatory process is brought under control. This so-called state of 'PGA-near-remission' negatively impacts individuals' functioning and potentiates...

A small clinical trial of vaporized cannabis for PTSD: suggestive results and directions for future study.

Trials September 9, 2023 Zach Walsh, Ian Mitchell, Kim Crosby et al.

The last few decades have seen increasing interest in the use of cannabis for post-traumatic stress disorder (PTSD). Recent attempts to evaluate the clinical efficacy of cannabis for PTSD were inconclusive and generalizability was limited by undesirable features of the study drug. The present clinical trial evaluated the effects of a commercially available chemovar that was delivered by...

Effect of postoperative application of esketamine on postoperative depression and postoperative analgesia in patients undergoing pancreatoduodenectomy: a randomized controlled trial protocol.

Trials August 19, 2023 Kaili Yu, Zhenguo Song, Bowen Zhang et al.

Pancreatoduodenectomy (PD) is traumatic, difficult to perform, and has a high incidence of postoperative complications and perioperative mortality. Postoperative complications and pain occur frequently and seriously affect the psychological status of patients. Esketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic and antidepressant effects. In this study, we aim to...

DOI: 10.1186/s13063-023-07575-8 (opens in new tab) Full text (opens in new tab) Esketamine Pancreatoduodenectomy Postoperative analgesia Postoperative depression

The effects of esketamine and treatment expectation in acute major depressive disorder (Expect): study protocol for a pharmacological fMRI study using a balanced placebo design

Trials August 13, 2023 Irina Falkenberg, Florian Bitsch, Wei Liu et al. 4 citations

Abstract Background Major depressive disorder (MDD) is a highly prevalent (8–15%), severely disabling disorder and is associated with enormous socioeconomic impact. Antidepressant medication for the treatment of MDD has proven effective in RCTs; however, placebo response is also substantial. Given the potential benefits of modulating the placebo response in patient care and pharmacological...

Effectiveness of four deconstructive meditative practices on well-being and self-deconstruction: study protocol for an exploratory randomized controlled trial.

Trials February 20, 2023 Javier García-campayo, Rinchen Hijar-Aguinaga, Yolanda López-del-hoyo et al. 6 citations

Introduction: The efficacy of interventions based on mindfulness and compassion has been demonstrated in both clinical and general population, and in different social contexts. These interventions include so-called attentional and constructive meditation practices, respectively. However, there is a third group, known as deconstructive meditation practices, which has not been scientifically...

Comparative effectiveness of a mindfulness-based intervention (M-Body) on depressive symptoms: study protocol of a randomized controlled trial in a Federally Qualified Health Center (FQHC).

Trials February 17, 2023 Inger Burnett-Zeigler, Elayne Zhou, Jennifer H Martinez et al.

Mindfulness-based interventions have been shown to improve psychological outcomes including stress, anxiety, and depression in general population studies. However, effectiveness has not been sufficiently examined in racially and ethnically diverse community-based settings. We will evaluate the effectiveness and implementation of a mindfulness-based intervention on depressive symptoms among...

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol

Trials January 19, 2023 Thorsten Barnhofer, Barnaby D. Dunn, Clara Strauss et al.

Background Major depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who...

On Top of Everything: a study protocol for a cluster-randomised controlled trial testing a teacher training programme to teach mindfulness among students in Danish upper secondary schools and schools of health and social care.

Trials January 6, 2023 Michelle Sand Beck, Lise Juul, Morten Frydenberg et al.

Mental health is decreasing among young people in Denmark. Our primary aim is to evaluate the effectiveness of a teacher training programme to teach mindfulness as part of regular classroom teaching in Danish upper secondary schools and schools of health and social care on students' self-reported mental well-being 6 months from baseline. Secondary aims are (1) to evaluate the effectiveness in a...

DOI: 10.1186/s13063-022-06920-7 (opens in new tab) Full text (opens in new tab) Mbsr Adolescent Mental health Mindfulness-based stress reduction +3