What side effects are associated with this type of intervention?

Mindfulness-Based Stress Reduction (MBSR) is generally well-tolerated with minimal side effects, though some individuals may experience temporary increases in anxiety or emotional discomfort as they confront stressors. Cognitive-Behavioral Therapy (CBT) for GAD is also well-tolerated, with few side effects, primarily involving emotional discomfort during exposure exercises. Common pharmacologic treatments for GAD, such as selective serotonin reuptake inhibitors (SSRIs) and benzodiazepines, can have side effects including nausea, dizziness, insomnia, sexual dysfunction, and dependency issues in the case of benzodiazepines.

What prior FDA approvals exist?

The primary FDA-approved pharmacological treatments for Generalized Anxiety Disorder (GAD) include selective serotonin reuptake inhibitors (SSRIs) such as sertraline, paroxetine, and escitalopram, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine and duloxetine. These medications are preferred due to their efficacy in reducing anxiety symptoms and their relatively favorable side effect profiles. These treatments are often chosen based on individual patient profiles and preferences, and they have been shown to be effective in managing the symptoms of GAD.

What other types of research exist?

Promising, novel alternatives to MBSR for GAD patients include transcranial magnetic stimulation (TMS), which has shown efficacy in reducing depressive symptoms and may be beneficial for anxiety, and vagus nerve stimulation (VNS), which has demonstrated positive outcomes in treatment-resistant depression and could be explored for anxiety management. Additionally, transcranial direct-current stimulation (tDCS) has shown potential in enhancing neurocognition and reducing depressive symptoms, making it a candidate for GAD treatment.

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Mindfulness-Based Stress Reduction for Generalized Anxiety Disorder

N/A

Recruiting

Led By Carly Minon, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Overall clinical anxiety severity of at least mild as defined by a CGI-S of at least 3

A primary mental health complaint (designated by the patient as the most important source of current distress and confirmed on structured clinical interview for DSM-5 diagnoses by a certified clinical evaluator) of Generalized Anxiety Disorder (GAD), as defined by DSM-5 criteria.

Must not have

Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation or inability to comply with study procedures assessed on clinical interview

A lifetime history of bipolar disorder, schizophrenia, psychosis, or delusional disorders; obsessive-compulsive disorder or an eating disorder in the past 12 months; neurocognitive disorders, intellectual disabilities, communication disorders or other cognitive dysfunction that could interfere with capacity to engage in therapy or complete study procedures; substance or alcohol use disorder (other than nicotine) in the last 6 months or otherwise unable to commit to refraining from alcohol use during the acute period of study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up experimental days 1 & 2 (visit 2 & 3) and experimental days 3 & 4 (visit 9 & 10)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While MBSR typically has minimal side effects, participants may experience increased emotional sensitivity or fatigue as they learn new mindfulness techniques. The stress education program might cause frustration if it doesn't meet the participant's expectations for treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have mild or more severe anxiety.

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

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I have been diagnosed with Generalized Anxiety Disorder.

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I am a man or a woman who has not gone through menopause, aged 18 to 50.

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I have been diagnosed with at least mild anxiety.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have a history of severe mental health issues or substance abuse that could affect my participation.

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I do not have metal implants, clips, fragments, or braces that prevent MRI scans.

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I have had a head injury that caused me to lose consciousness or have seizures or ongoing thinking problems.

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I am not pregnant and use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ experimental days 1 & 2 (visit 2 & 3) and experimental days 3 & 4 (visit 9 & 10)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~experimental days 1 & 2 (visit 2 & 3) and experimental days 3 & 4 (visit 9 & 10)

This trial's timeline: 3 weeks for screening, Varies for treatment, and experimental days 1 & 2 (visit 2 & 3) and experimental days 3 & 4 (visit 9 & 10) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learning

Pre-post changes in fMRI measures of functional activation in the whole brain neural connectivity during fear extinction learning

Secondary study objectives

Change in Skin Conductance Response (SCR).

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Mindfulness-Based Stress Reduction (MBSR) works by promoting mindfulness through meditation and yoga, which helps patients become more aware of their thoughts and feelings in a non-judgmental manner. This practice reduces stress and anxiety by enhancing relaxation and emotional regulation. For Generalized Anxiety Disorder (GAD) patients, understanding these mechanisms is important as it highlights how MBSR can alter neural pathways associated with stress and anxiety, leading to improved mental health and symptom management.