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NCT05064813

MBSR Mechanisms in GAD

Active, Not Recruiting
NAAges 18–50InterventionalBasic science
NYU Langone Health
~240 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Mindfulness Based Stress Reduction MBSR InterventionStress Education Control Condition (SE)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learning
Measured over Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)
+1 more outcome measured

Conditions

Generalized Anxiety Disorder

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Generalized Anxiety Disorder

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Naomi Simon, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
  • Candace Raio, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Male or pre-menopausal female outpatients aged 18 to 50 years of age
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.
Overall clinical anxiety severity of at least mild as defined by a CGI-S of at least 3.
Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.

Exclusion

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.
Patients with significant suicidal ideation (assessed by CSSR-S SI score greater than 2) or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
Patients must be free of concurrent benzodiazepine, antipsychotic, and stimulant medication for at least 4 weeks prior to initiation of randomized treatment. Other psychiatric medications such as antidepressants that have been stable for at least 4 weeks prior to randomization will be permitted.
Inability to understand study procedures or informed consent process, or significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview) or inability to comply with study procedures (such as planned extended travel) assessed on clinical interview
Serious current unstable medical illness, or a condition for which hospitalization may be likely within the next year as assessed by medical history and physical exam. If any questions about medical safety emerge, consent will be formally obtained to contact patient's PCP in order to determine whether any medical concerns making participation unsafe or not feasible (such as need for extended inpatient care) are present; MBSR and SE, however, do not require intensive exercise capacity or mobility.
Pregnant women (to be ruled out by urine ß-HCG) and women of childbearing potential who are not using medically accepted forms of contraception (such as IUD, oral contraceptives, barrier devices, condoms and foam, or implanted progesterone rods stabilized for at least 3 months).
Any concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of GAD or with any mindfulness and/or meditation component is excluded. Prohibited psychotherapy includes CBT, DBT, ACT, mindfulness based approaches, or psychodynamic therapy focusing on exploring specific, dynamic causes of the GAD symptomatology and providing management skills. General supportive therapy initiated greater than 3 months prior is acceptable.
Individuals who have completed a course of MBSR or an equivalent meditation training or who have an ongoing regular meditation practice in the past 2 years.
Patients with a history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment.
Contraindications for MRI including metal implants, surgical clips, probability of metal fragments, or braces that are prohibited due to severe risk of injury.
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What this trial measures

  • Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learningExperimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)

    The primary clinical outcome measure will be treatment response. This is measured by The Clinical Global Impression-Improvement (CGI-I) scale is a single clinician-reported item that assesses how much the patient's illness has improved or worsened relative to baseline and is rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse,) 6 (much worse), or 7 (very much worse). The CGI-I scale is widely used and well validated, and is sensitive to changes in neuropsychiatric symptoms.

  • Pre-post changes in fMRI measures of functional activation in the whole brain neural connectivity during fear extinction learningExperimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)

    The primary clinical outcome measure will be treatment response. This is measured by The Clinical Global Impression-Improvement (CGI-I) scale is a single clinician-reported item that assesses how much the patient's illness has improved or worsened relative to baseline and is rated as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse,) 6 (much worse), or 7 (very much worse). The CGI-I scale is widely used and well validated, and is sensitive to changes in neuropsychiatric symptoms.