Mindfulness-Based Stress Reduction for Generalized Anxiety Disorder

Recruiting in Palo Alto (17 mi)

Overseen by Candace Raio, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Must not be taking: Benzodiazepines, Antipsychotics, Stimulants

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group

Approved in 2 Jurisdictions

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.

Will I have to stop taking my current medications?

You will need to stop taking benzodiazepines, antipsychotics, and stimulants for at least 4 weeks before starting the trial. However, if you are on antidepressants and have been stable on them for at least 4 weeks, you can continue taking them during the study.

What data supports the effectiveness of the treatment Mindfulness-Based Stress Reduction (MBSR) for Generalized Anxiety Disorder?

Research shows that Mindfulness-Based Stress Reduction (MBSR) can help improve mental health and reduce symptoms of stress, anxiety, and depression in both clinical and non-clinical groups. A specific study on generalized anxiety disorder found that MBSR was effective in reducing anxiety and stress reactivity. ^{1 2 3 4 5}

Is Mindfulness-Based Stress Reduction (MBSR) safe for humans?

Mindfulness-Based Stress Reduction (MBSR) is generally considered safe for humans and has been used for various conditions like anxiety, depression, and chronic pain. It is a meditation therapy that does not involve medication, and studies suggest it can improve mental health without significant safety concerns. ^{1 2 4 5 6}

How is the Mindfulness-Based Stress Reduction treatment different from other treatments for generalized anxiety disorder?

Mindfulness-Based Stress Reduction (MBSR) is unique because it uses mindfulness meditation to help reduce anxiety and stress without medication, focusing on being present in the moment. Unlike traditional therapies, it is a non-drug approach that can improve mental health and reduce symptoms of anxiety, stress, and depression in both clinical and non-clinical settings. ^{1 2 4 7 8}

Research Team

Naomi Simon, MD

Principal Investigator

NYU Langone Health

Candace Raio, PhD

Principal Investigator

NYU Langone Health

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

Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol

I have mild or more severe anxiety.

My main health issue is Generalized Anxiety Disorder, confirmed by a professional.

Exclusion Criteria

I haven't taken any benzodiazepines, antipsychotics, or stimulants in the last 4 weeks.

You are left-handed.

I understand the study procedures and consent process and can follow them.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline assessments including fMRI scans and clinical evaluations

1 week

1 visit (in-person)

Treatment

Participants undergo 8 weeks of group intervention with either MBSR or stress education

8 weeks

8 group sessions (in-person)

Experimental Days

Two sets of experimental days including fMRI scans to assess neural changes

12 weeks apart

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

Treatment Details

Interventions

• Mindfulness Based Stress Reduction MBSR Intervention (Behavioral Intervention)
• Stress Education Control Condition (SE) (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Mindfulness Based Stress Reduction Group Experimental Treatment 1 Intervention

8 weeks of Mindfulness Based Stress Reduction Group (MBSR).

Group II: Stress Education Group Active Control 1 Intervention

8 weeks of Stress Education Group (SE).

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

Findings from Research

A systematic review of 18 studies found that Mindfulness Based Stress Reduction (MBSR) therapy significantly improves the conditions of patients with chronic illnesses such as cancer, hypertension, and diabetes.

MBSR offers a promising alternative treatment method that helps patients manage their diseases more effectively, although more research is needed to fully understand its mechanisms and potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. Niazi, AK., Niazi, SK.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

Mindfulness-Based Stress Reduction (MBSR) is a program designed to help individuals manage stress and emotions through mindfulness meditation, but current research shows significant methodological issues and a lack of robust evidence regarding its effectiveness.

While there is some preliminary evidence suggesting MBSR may be beneficial, the overall findings do not strongly support its widespread endorsement, indicating a need for more rigorous research to better understand its efficacy and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? Bishop, SR.[2022]

In a randomized controlled trial with 93 participants diagnosed with generalized anxiety disorder (GAD), both Mindfulness-Based Stress Reduction (MBSR) and an attention control group showed significant reductions in anxiety symptoms, but MBSR was more effective in improving overall anxiety ratings and coping during stress tests.

MBSR not only reduced anxiety symptoms more than the control group but also enhanced participants' ability to cope with stress, as indicated by greater improvements in self-reported anxiety and positive self-statements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. Hoge, EA., Bui, E., Marques, L., et al.[2022]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

Mindfulness-based stress reduction (MBSR) has been shown to effectively reduce stress levels in healthy individuals, as indicated by a review of ten studies, although most of these studies were of low quality.

MBSR not only reduces stress but also enhances traits like empathy and self-compassion, while showing similar efficacy to standard relaxation training, highlighting the need for more rigorous research to confirm its specific benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. Chiesa, A., Serretti, A.[2022]

An 8-week mindfulness-based cognitive therapy (MBCT) course significantly reduced anxiety levels in participants with generalized anxiety disorder (GAD) compared to usual care, based on a study of 182 participants followed for 5 months.

Both MBCT and cognitive-behavioral therapy-based psychoeducation were more effective than usual care in decreasing anxiety symptoms, with psychoeducation also improving worry, depressive symptoms, and mental health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy v. group psychoeducation for people with generalised anxiety disorder: randomised controlled trial. Wong, SY., Yip, BH., Mak, WW., et al.[2019]

Cognitive Behavioral Therapy (CBT) is currently the most effective psychotherapy for Generalized Anxiety Disorder (GAD), but it only achieves about a 50% reduction in symptoms and has high relapse rates.

Classical Mindfulness (CM) offers unique strategies that may directly address the core symptoms of GAD, potentially enhancing treatment outcomes when combined with CBT, as suggested by preliminary evidence and case studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New Strategies for Combining Mindfulness with Integrative Cognitive Behavioral Therapy for the Treatment of Generalized Anxiety Disorder. Rapgay, L., Bystritsky, A., Dafter, RE., et al.[2021]

References

1. India pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction: a non-pharmacological approach for chronic illnesses. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

What do we really know about mindfulness-based stress reduction? [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of mindfulness meditation for generalized anxiety disorder: effects on anxiety and stress reactivity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based cognitive therapy v. group psychoeducation for people with generalised anxiety disorder: randomised controlled trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

New Strategies for Combining Mindfulness with Integrative Cognitive Behavioral Therapy for the Treatment of Generalized Anxiety Disorder. [2021]