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Trials

ISSN 1745-6215

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

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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...

Treatment of sleep disturbances in trauma-affected refugees: Study protocol for a randomised controlled trial.

Trials November 6, 2017 Hinuga Sandahl, Poul Jennum, Lone Baandrup et al.

Sleep disturbances are often referred to as a hallmark and as core symptoms of post-traumatic stress disorder (PTSD). Untreated sleep disturbances can contribute to the maintenance and exacerbation of PTSD symptoms, which may diminish treatment response and constitute a risk factor for poor treatment outcome. Controlled trials on treatment of sleep disturbances in refugees suffering from PTSD...

The effect of a mindfulness-based intervention in cognitive functions and psychological well-being applied as an early intervention in schizophrenia and high-risk mental state in a Chilean sample: study protocol for a randomized controlled trial

Trials May 25, 2017 Alvaro Ignacio Langer, Carlos Schmidt, Rocío Mayol et al. 42 citations

BACKGROUND: According to the projections of the World Health Organization, 15% of all disabilities will be associated with mental illnesses by 2020. One of the mental disorders with the largest social impacts due to high personal and family costs is psychosis. Among the most effective psychological approaches to treat schizophrenia and other psychotic disorders at the world level is cognitive...

A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial

Trials May 15, 2017 Hants Williams, Susan G. Silva, Leigh Ann Simmons et al. 6 citations

BACKGROUND: One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective...

A proof-of-concept investigation into ketamine as a pharmacological treatment for alcohol dependence: study protocol for a randomised controlled trial

Trials April 4, 2017 Amy Mcandrew, Will Lawn, Tobias Stevens et al. 20 citations

BACKGROUND: Worldwide, alcohol abuse is a burgeoning problem. Abstinence is key to allow recovery of physical and mental health as well as quality of life, but treatment for alcohol dependence is associated with high relapse rates. Preliminary data have suggested that a combined repeated ketamine and psychological therapy programme may be effective in reducing relapse in severe alcohol use...

The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial.

Trials December 1, 2016 Zarah Rowland, Mario Wenzel, Thomas Kubiak

Background: Self-control is an important ability in everyday life, showing associations with health-related outcomes. The aim of the Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains (SMASH) study is twofold: first, the effectiveness of a computer-based mindfulness training will be evaluated in a randomized controlled trial. Second, the...

Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial.

Trials October 13, 2016 Lianne Tomfohr-Madsen, Tavis S. Campbell, Gerald F. Giesbrecht et al.

Clinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological...

Efficacy and mechanisms of imagery rescripting and imaginal exposure for nightmares: study protocol for a randomized controlled trial.

Trials September 26, 2016 Anna E Kunze, Jaap Lancee, Nexhmedin Morina et al.

Background: Recurrent nightmares can effectively be treated with cognitive-behavioral techniques such as imagery rehearsal therapy, which involves imagery rescripting (IR) of nightmares, and imaginal exposure (IE) therapy. However, the underlying mechanisms of these treatments remain largely unknown. To investigate this, we identified a number of variables that might mediate the therapeutic...

DOI: 10.1186/s13063-016-1570-3 (opens in new tab) Full text (opens in new tab) Rct Imagery rehearsal therapy Nightmare disorder Imaginal exposure +3

Pilot study evaluating a brief mindfulness intervention for those with chronic pain: study protocol for a randomized controlled trial

Trials June 2, 2016 Ana Howarth, Linda Perkins-Porras, Jared G. Smith et al. 10 citations

BACKGROUND: The burden of chronic pain is a major challenge, impacting the quality of life of patients. Intensive programmes of mindfulness-based therapy can help patients to cope with chronic pain but can be time consuming and require a trained specialist to implement. The self-management model of care is now integral to the care of patients with chronic pain; home-based interventions can be...

The effectiveness of mindfulness-based stress reduction (MBSR) for survivors of breast cancer: study protocol for a randomized controlled trial

Trials April 22, 2016 Jiayan Huang, Lu Shi

BackgroundAfter treatment completion, breast cancer (BC) survivors frequently experience residual symptoms of pain, fatigue, high levels of psychological stress, anxiety, depression, fear of recurrence, and metastasis. Post-treatment stress, in particular, can adversely affect health-related quality of life, which, in turn, induces onset or recurrence of chronic diseases. Effective...

A telemedicine meditation intervention for people with multiple sclerosis and their caregivers: study protocol for a randomized controlled trial.

Trials January 4, 2016 Cesare Cavalera, Francesco Pagnini, Marco Rovaris et al.

Mindfulness-based interventions, modified and shortened versions of meditation teachings, have proved to be effective in the improvement of quality of life in many clinical conditions, including chronic diseases. Preliminary results available in the literature and in clinical experience indicate a high potential for this treatment for the reduction of psychological suffering in people with...

Mindfulness-based cognitive therapy for inflammatory bowel disease patients: findings from an exploratory pilot randomised controlled trial.

Trials August 25, 2015 Mariyana Schoultz, Iain Atherton, Angus Watson

Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with a relapsing disease course. Managing the relapsing nature of the disease causes daily stress for IBD patients; thus, IBD patients report higher rates of depression and anxiety than the general population. Mindfulness-based Cognitive Therapy (MBCT) is an evidence-based psychological program designed to help manage...

A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial.

Trials February 8, 2015 Sophie Merle Kuhlmann, Arne Bürger, Günter Esser et al.

Background: Medical training is very demanding and associated with a high prevalence of psychological distress. Compared to the general population, medical students are at a greater risk of developing a psychological disorder. Various attempts of stress management training in medical school have achieved positive results on minimizing psychological distress; however, there are often...

DOI: 10.1186/s13063-014-0533-9 (opens in new tab) Full text (opens in new tab) Mindfulness Humans Clinical protocols Data interpretation, statistical +4

Update to the study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment depressive relapse/recurrence: the PREVENT trial.

Trials June 10, 2014 Willem Kuyken, Sarah Byford, Richard Byng et al.

Background: Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them...

Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial.

Trials May 10, 2013 Catherine Malboeuf-Hurtubise, Marie Achille, Serge Sultan et al.

Background: Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission....

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial.

Trials October 20, 2010

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial.