Trial Summary
What is the purpose of this trial?This trial compares mindfulness meditation and stress education in people with Generalized Anxiety Disorder (GAD). It aims to see how these treatments change brain areas that handle fear and stress. The study also looks at whether men and women respond differently to mindfulness meditation. Brain scans will help understand these changes and predict who might benefit most from mindfulness meditation. Mindfulness-based stress reduction has been shown to effectively reduce symptoms of anxiety and panic in patients with generalized anxiety disorder.
Is Mindfulness-Based Stress Reduction (MBSR) a promising treatment for Generalized Anxiety Disorder?Yes, Mindfulness-Based Stress Reduction (MBSR) is a promising treatment for Generalized Anxiety Disorder. Research shows that MBSR can help reduce anxiety and stress, improve mental health, and is effective for people with anxiety disorders. It is a non-drug approach that uses mindfulness meditation to manage symptoms.34567
What safety data exists for Mindfulness-Based Stress Reduction (MBSR) for anxiety?The available research indicates that Mindfulness-Based Stress Reduction (MBSR) is a safe and effective intervention for reducing symptoms of stress, anxiety, and depression in both clinical and non-clinical populations. It has been used for various conditions, including anxiety disorders, without significant safety concerns. MBSR is a non-pharmacological approach that has been implemented in healthcare settings and adapted for different groups, including healthcare staff, suggesting its broad acceptability and safety.24568
What data supports the idea that Mindfulness-Based Stress Reduction for Generalized Anxiety Disorder is an effective treatment?The available research shows that Mindfulness-Based Stress Reduction (MBSR) can be an effective treatment for reducing anxiety. A randomized controlled trial specifically focused on generalized anxiety disorder (GAD) found that MBSR helped reduce anxiety and stress reactivity. Additionally, a review of 31 studies indicated that MBSR improves mental health and reduces symptoms of stress, anxiety, and depression in various populations. This suggests that MBSR is a promising option for managing anxiety compared to other treatments.14568
Do I have to stop taking my current medications for the trial?The trial requires you to stop taking benzodiazepines, antipsychotics, and stimulants for at least 4 weeks before starting. However, you can continue taking antidepressants if they have been stable for at least 4 weeks before the trial.
Eligibility Criteria
This trial is for adults aged 18-50 with Generalized Anxiety Disorder (GAD) who experience at least mild anxiety. Participants must be male or pre-menopausal females, not pregnant, using contraception if applicable, and vaccinated against COVID-19. They should not have certain psychiatric conditions or recent substance abuse issues and must agree to avoid alcohol during the study.Inclusion Criteria
I have mild or more severe anxiety.
My main health issue is Generalized Anxiety Disorder, confirmed by a professional.
I have been diagnosed with Generalized Anxiety Disorder.
I am a man or a woman who has not gone through menopause, aged 18 to 50.
I have been diagnosed with at least mild anxiety.
Exclusion Criteria
I understand the study procedures and consent process and can follow them.
I do not have a history of severe mental health issues or substance abuse that could affect my participation.
I do not have metal implants, clips, fragments, or braces that prevent MRI scans.
I have had a head injury that caused me to lose consciousness or have seizures or ongoing thinking problems.
I am not pregnant and use birth control.
Treatment Details
The study compares Mindfulness Based Stress Reduction (MBSR) with a stress education program in treating GAD. It involves an 8-week group intervention with assessments before, after, and three months post-treatment. The effects on brain function will also be studied using fMRI scans.
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness Based Stress Reduction GroupExperimental Treatment1 Intervention
8 weeks of Mindfulness Based Stress Reduction Group (MBSR).
Group II: Stress Education GroupActive Control1 Intervention
8 weeks of Stress Education Group (SE).
Mindfulness Based Stress Reduction MBSR Intervention is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Mindfulness-Based Stress Reduction for:
- Generalized Anxiety Disorder (GAD)
- Anxiety Disorders
🇪🇺 Approved in European Union as Mindfulness-Based Stress Reduction for:
- Generalized Anxiety Disorder (GAD)
- Anxiety Disorders
Find a clinic near you
Research locations nearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
References
What do we really know about mindfulness-based stress reduction? [2022]Mindfulness-Based Stress Reduction (MBSR) is a clinical program, developed to facilitate adaptation to medical illness, which provides systematic training in mindfulness meditation as a self-regulatory approach to stress reduction and emotion management. There has been widespread and growing use of this approach within medical settings in the last 20 years, and many claims have been made regarding its efficacy. This article will provide a critical evaluation of the available state of knowledge regarding MBSR and suggestions for future research.
Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. [2022]Mindfulness-based stress reduction (MBSR) is a clinically standardized meditation that has shown consistent efficacy for many mental and physical disorders. Less attention has been given to the possible benefits that it may have in healthy subjects. The aim of the present review and meta-analysis is to better investigate current evidence about the efficacy of MBSR in healthy subjects, with a particular focus on its benefits for stress reduction.
New Strategies for Combining Mindfulness with Integrative Cognitive Behavioral Therapy for the Treatment of Generalized Anxiety Disorder. [2021]Generalized anxiety disorder (GAD) severely impacts social functioning, distress levels, and utilization of medical care compared with that of other major psychiatric disorders. Neither pharmacological nor psychotherapy interventions have adequately controlled cardinal symptoms of GAD: pervasive excessive anxiety and uncontrollable worry. Research has established cognitive behavioral therapy (CBT) as the most effective psychotherapy for controlling GAD; however, outcomes remain at only 50% reduction, with high relapse rates. Mindfulness has been integrated with CBT to treat people suffering from numerous psychiatric disorders, with mindfulness based stress reduction (MBSR) being the most researched. Preliminary evidence supports MBSR's potential for controlling GAD symptoms and key researchers suggest mindfulness practices possess key elements for treating GAD. Classical mindfulness (CM) differs significantly from MBSR and possesses unique potentials for directly targeting process and state GAD symptoms inadequately treated by CBT. This article introduces the theory and practice of CM, its differences from MBSR, and a critical review of MBSR and CBT treatments for GAD. CM strategies designed to complement CBT targeting cardinal GAD symptoms are outlined with a case study illustrating its use.
Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]Mindfulness Based Stress Reduction (MBSR) therapy is a meditation therapy, though originally designed for stress management, it is being used for treating a variety of illnesses such as depression, anxiety, chronic pain, cancer, diabetes mellitus, hypertension, skin and immune disorders.
Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. [2022]Mindfulness meditation has met increasing interest as a therapeutic strategy for anxiety disorders, but prior studies have been limited by methodological concerns, including a lack of an active comparison group. This is the first randomized, controlled trial comparing the manualized Mindfulness-Based Stress Reduction (MBSR) program with an active control for generalized anxiety disorder (GAD), a disorder characterized by chronic worry and physiologic hyperarousal symptoms.
[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]Mindfulness-based stress reduction (MBSR) is a manualised group intervention using mindfulness training as a means of reducing the suffering associated with physical, psychosomatic and psychiatric illness. A review of the literature includes 31 randomised studies. Results indicate that MBSR may improve mental health and reduce symptoms of stress, anxiety and depression in both clinical and non-clinical populations. Implementation in the health-care system is recommended to take place over time to secure sufficient education of MBSR teachers in Denmark.
Mindfulness-based cognitive therapy v. group psychoeducation for people with generalised anxiety disorder: randomised controlled trial. [2019]Research suggests that an 8-week mindfulness-based cognitive therapy (MBCT) course may be effective for generalised anxiety disorder (GAD).
Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]Mindfulness-based stress reduction (MBSR) is a well-known mindfulness meditation program for patients that also may benefit health care providers and clinic staff themselves. An abbreviated MBSR program adapted into 6 weekly 75-minute sessions held during staff lunch breaks provided a feasible and acceptable staff training approach within the workplace setting.