Mindfulness-Based Stress Reduction for Generalized Anxiety Disorder

Overseen By Matthew Irwin

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Benzodiazepines, Antipsychotics, Stimulants

Disqualifiers: Bipolar, Schizophrenia, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 14

Duration: 8 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how mindfulness-based stress reduction (MBSR) and stress education affect individuals with generalized anxiety disorder (GAD). Researchers are particularly interested in how these approaches impact the brain and whether differences exist between men and women. Participants will join an eight-week program focused on either MBSR or stress education. Those diagnosed with GAD, who find it affects their daily life, may be well-suited for this trial.

As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance anxiety management strategies.

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 prior data suggests that Mindfulness-Based Stress Reduction is safe for individuals with generalized anxiety disorder?

Research shows that Mindfulness-Based Stress Reduction (MBSR) is generally safe and easy to manage. Studies have found that MBSR can reduce anxiety symptoms as effectively as medications like escitalopram, but without major side effects. In one study, both MBSR and medication lowered anxiety symptoms in patients over eight weeks. These studies reported no serious negative effects, suggesting that MBSR is a safe option for people with anxiety disorders. Prospective participants should consult a healthcare provider about any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Mindfulness-Based Stress Reduction (MBSR) is unique because it offers a non-pharmaceutical approach to managing Generalized Anxiety Disorder (GAD). While most treatments for GAD, like medications and cognitive-behavioral therapy, focus on altering brain chemistry or thought patterns, MBSR emphasizes mindfulness meditation and awareness techniques to reduce stress and anxiety. Researchers are excited about MBSR because it empowers individuals to actively participate in their healing process, potentially leading to better stress management without the side effects of medication. Additionally, MBSR can be an accessible and cost-effective option, making it an appealing alternative or complement to existing treatments.

What evidence suggests that Mindfulness-Based Stress Reduction might be an effective treatment for generalized anxiety disorder?

Research has shown that Mindfulness-Based Stress Reduction (MBSR), one of the treatments in this trial, can help reduce anxiety symptoms. One study found MBSR to be as effective as medication in lowering anxiety after eight weeks. Another study demonstrated that MBSR not only reduced anxiety but also improved stress coping. A review of multiple studies confirmed that mindfulness meditation significantly reduces anxiety in people with anxiety disorders. These findings suggest that MBSR could be a promising way to manage generalized anxiety disorder. Meanwhile, the Stress Education Control Condition (SE), another treatment arm in this trial, will also be evaluated for its effectiveness in managing anxiety symptoms. ^{3 4 6 7 8}

Who Is on the Research Team?

Candace Raio, PhD

Principal Investigator

NYU Langone Health

Naomi Simon, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

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

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.

How Is the Trial Designed?

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).

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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3494227/

Effect of Mindfulness Based Stress Management on ... Discussion. This study evaluated effectiveness of a stress reduction program based on mindfulness meditation practices for generalized anxiety disorder.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3772979/

Randomized Controlled Trial of Mindfulness Meditation for ... These results suggest that MBSR may have a beneficial effect on anxiety symptoms in GAD, and may also improve stress reactivity and coping.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725003192

Effectiveness of mindfulness-based cognitive therapy for ... This study evaluated MBCT's effectiveness for GAD and examined whether childhood maltreatment moderates its impact.

4. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2798510

Mindfulness-Based Stress Reduction vs Escitalopram for ... Mindfulness meditation has been found to help reduce anxiety; a recent meta-analysis of trials with anxiety disorders found a significant benefit with ...

5. pcori.org pcori.org/research-results/2017/comparing-meditation-versus-medicine-patients-anxiety-disorders

Comparing Meditation versus Medicine for Patients with ... After eight weeks, when delivered in person, MBSR worked about the same as the medicine to reduce anxiety symptoms. Both treatments reduced patients' anxiety ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4203918/

Effects of Mindfulness-Based Stress Reduction (MBSR) on ... MBSR training in patients with SAD may reduce emotional reactivity while enhancing emotion regulation.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05064813

Study Details | NCT05064813 | MBSR Mechanisms in GAD The purpose of this study is to understand the neural mechanisms that drive response to MBSR compared to stress education in patients with generalized anxiety ...

8. nature.com nature.com/articles/s41598-021-99882-w

and mindfulness-based interventions for DSM-5 anxiety ... This meta-analysis systematically reviewed the evidence on standardized acceptance-/mindfulness-based interventions in DSM-5 anxiety disorders.