| NCT ID | NCT05064813 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Generalized Anxiety Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-11-18 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-11-18 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 disorder (GAD), and to examine the degree to which sex differences in MBSR response are explained by sex differences in these mechanisms. A total of 150 eligible participants with a primary diagnosis of GAD will be randomized to either an 8-week group MBSR or stress education program. The study will include preliminary screening, experimental visits, including fMRI, group intervention visits, and assessments at baseline, endpoint, and 3-month follow-up.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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. * Left handed
Contact & Investigator
Naomi Simon, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05064813 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Generalized Anxiety Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05064813 currently recruiting?
Yes, NCT05064813 is actively recruiting participants. Contact the research team at anxietystudy@nyulangone.org for enrollment information.
Where is the NCT05064813 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05064813 clinical trial?
NCT05064813 is sponsored by NYU Langone Health. The principal investigator is Naomi Simon, MD at NYU Langone Health. The trial plans to enroll 150 participants.
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