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Mindfulness-Based Stress Reduction for Generalized Anxiety Disorder

N/A
Recruiting
Led By Naomi Simon, 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
Male or pre-menopausal female outpatients aged 18 to 50 years of age
Overall clinical anxiety severity of at least mild as defined by a CGI-S of at least 3
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

Study Summary

This trial is investigating whether mindfulness-based stress reduction (MBSR) or stress education can help ease generalized anxiety disorder (GAD), and whether any sex differences in MBSR response are explained by sex differences in neural mechanisms.

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.Check my eligibility
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.See study design
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 am a man or a pre-menopausal woman aged between 18 and 50.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Skin Conductance Response (SCR).

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).

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
816,266 Total Patients Enrolled
4 Trials studying Generalized Anxiety Disorder
302 Patients Enrolled for Generalized Anxiety Disorder
Naomi Simon, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
123 Total Patients Enrolled
Mohammed Milad, PhDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
286 Total Patients Enrolled

Media Library

Mindfulness Based Stress Reduction MBSR Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05064813 — N/A
Generalized Anxiety Disorder Research Study Groups: Stress Education Group, Mindfulness Based Stress Reduction Group
Generalized Anxiety Disorder Clinical Trial 2023: Mindfulness Based Stress Reduction MBSR Intervention Highlights & Side Effects. Trial Name: NCT05064813 — N/A
Mindfulness Based Stress Reduction MBSR Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05064813 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there unfilled opportunities to join this experiment?

"Affirmative. The details of this medical trial, which was first posted on November 1st 2021, are publicly available through clinicaltrials.gov and indicate that it is currently enrolling participants - 150 from one location to be exact."

Answered by AI

How many participants is this experiment currently accommodating?

"Correct. According to clinicaltrials.gov, this medical trial which was initially published on November 1st 2021 is still actively recruiting participants. 150 patients are required for the study at one site."

Answered by AI

Do I meet the qualifications to participate in this experiment?

"In order to be eligible for this research, participants must have been diagnosed with an anxiety disorder and lie within the age bracket of 18-50. All in all, 150 people are required for this project."

Answered by AI

Does the current research protocol extend to individuals above 30 years of age?

"In line with the eligibility requirements for this investigation, participants must be between 18 years old and 50 years old."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

How responsive is this trial?

Typically responds via
Email
Average response time
  • < 2 Days
Most responsive sites:
  1. NYU Langone Health: < 48 hours
~69 spots leftby Mar 2026