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Trials

ISSN 1745-6215

29 papers in the library · 102 citations · publishing 2010-2026

Papers

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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...

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...

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...

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...

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...

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...

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...

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

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

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...

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...

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...

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....

Nitrous oxide (N2O) and subsequent open-label SSRI treatment of adolescents with depression (NOTAD): study protocol for a randomised controlled trial.

Trials December 22, 2017 Richard M Stewart, Janice W Y Wong, Kevin C Runions et al.

The first line of pharmacological treatment for severe depressive disorders in young people is selective serotonin reuptake inhibitors (SSRIs). However, beneficial clinical effects are rarely observed before several weeks into treatment. Nitrous oxide (N2O) has a long-standing safety record for pain relief and has been used in adults and young people. In adults with severe treatment-resistant...