Generalized Anxiety DisorderNCT05064813
MBSR Mechanisms in GAD
A study testing Mindfulness Based Stress Reduction MBSR Intervention in people with Generalized Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Mindfulness Based Stress Reduction MBSR Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elucidating Neural Mechanisms and Sex Differences in Response to Mindfulness Based Stress Reduction in Generalized Anxiety Disorder
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.
Read the detailed description
Mindfulness-Based Stress Reduction (MBSR) has demonstrated efficacy for Generalized Anxiety Disorder (GAD), yet there remains a major knowledge gap about its neural mechanisms.
This study will examine functional activation of brain regions associated with the fear extinction network (ventromedial prefrontal cortex (vmPFC), hippocampus, and amygdala) as a specific probe of the 'instinctual' type of emotion regulation as well as large-scale functional connectivity as a marker of neural plasticity changes. Sex differences in MBSR-induced neural changes and their relationship to sex differences in clinical GAD response will be examined. Finally, a novel statistical approach will be used to explore whether baseline neural measures can predict neural changes and clinical symptom reduction to identify likely MBSR responders.
The unique combination of a focus on GAD, an anxiety condition with established emotion regulation difficulties implicating target neural circuits, previously demonstrated MBSR efficacy, and sex differences with rigorous fMRI behavioral probes with novel analytic approaches ought to provide major new insights about MBSR versus stress education mechanisms and sex considerations, moving towards precision medicine that could guide future treatment development research.
Eligible participants with Generalized Anxiety Disorder will be 2:1 randomized to group intervention with MBSR or stress education classes. They will participate for 13-14 weeks plus one 3 month follow up assessment (23-24 weeks from screening). Full participation includes screening, baseline, endpoint and 3 month follow up assessments, two sets of experimental days 12 weeks apart which include fMRI scans, and 8 weeks of the assigned group intervention (either MBSR or stress education).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Mindfulness Based Stress Reduction MBSR Intervention, Stress Education Control Condition (SE)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Stress Reduction MBSR InterventionBehavioural
MBSR is an 8-week group-based course developed by Jon Kabat-Zinn (1990) and colleagues at the University of Massachusetts' Center for Mindfulness. Weekly 2.5 hour long classes are given once a week, as well as one day-long weekend class. The classes instruct participants in the theory and practice of several forms of mindfulness meditation, breathing awareness, and mindfulness stretching exercises. Teaching of the theory of mindfulness and experiential practice are both utilized during weekly classes and at-home CD-guided practice sessions.
Stress Education Control Condition (SE)Behavioural
Stress Education (SE) was designed to provide an active comparator condition that does not include overlapping active components of mindfulness meditation with MBSR. It will also be delivered over 8-weekly, in-person, 2.5 hour group sessions of the same size (n=4 to 6). In SE, participants receive extensive information about stress and health, but will not receive any MBSR or other mind-body training. Instead, stress relevant psycho-educational information will be taught.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Stress Reduction Group | Experimental | 8 weeks of Mindfulness Based Stress Reduction Group (MBSR). Receives: Behavioral: Mindfulness Based Stress Reduction MBSR Intervention |
| Stress Education Group | Active comparator | 8 weeks of Stress Education Group (SE). Receives: Behavioral: Stress Education Control Condition (SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learning
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.
Measured: Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)
Pre-post changes in fMRI measures of functional activation in the whole brain neural connectivity during fear extinction learning
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.
Measured: Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)
Secondary outcomes (1)
Change in Skin Conductance Response (SCR).
SCR will be computed for each trial by subtracting the mean SCR during the last seconds of context presentation from the maximal skin conductance response reached during CS presentation during the fear conditioning and extinction paradigm
Measured: Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start18 Nov 2021
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naomi Simon, MD, Principal investigator, NYU Langone HealthCandace Raio, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064813
- Sponsor's protocol ID
- 21-00454
- Status last verified
- Jul 2026
- First submitted
- 14 Sep 2021
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The primary cleaned deidentified dataset 12 months after database lock or primary publication or whatever comes first
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating Neural Mechanisms and Sex Differences in Response to Mindfulness Based Stress Reduction in Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05064813
- Acronym / sponsor ID
- 21-00454
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mindfulness-Based Stress Reduction (MBSR) has demonstrated efficacy for Generalized Anxiety Disorder (GAD), yet there remains a major knowledge gap about its neural mechanisms.
This study will examine functional activation of brain regions associated with the fear extinction network (ventromedial prefrontal cortex (vmPFC), hippocampus, and amygdala) as a specific probe of the 'instinctual' type of emotion regulation as well as large-scale functional connectivity as a marker of neural plasticity changes. Sex differences in MBSR-induced neural changes and their relationship to sex differences in clinical GAD response will be examined. Finally, a novel statistical approach will be used to explore whether baseline neural measures can predict neural changes and clinical symptom reduction to identify likely MBSR responders.
The unique combination of a focus on GAD, an anxiety condition with established emotion regulation difficulties implicating target neural circuits, previously demonstrated MBSR efficacy, and sex differences with rigorous fMRI behavioral probes with novel analytic approaches ought to provide major new insights about MBSR versus stress education mechanisms and sex considerations, moving towards precision medicine that could guide future treatment development research.
Eligible participants with Generalized Anxiety Disorder will be 2:1 randomized to group intervention with MBSR or stress education classes. They will participate for 13-14 weeks plus one 3 month follow up assessment (23-24 weeks from screening). Full participation includes screening, baseline, endpoint and 3 month follow up assessments, two sets of experimental days 12 weeks apart which include fMRI scans, and 8 weeks of the assigned group intervention (either MBSR or stress education).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Stress Reduction Group | Experimental | Behavioral: Mindfulness Based Stress Reduction MBSR Intervention8 weeks of Mindfulness Based Stress Reduction Group (MBSR). |
| Stress Education Group | Active comparator | Behavioral: Stress Education Control Condition (SE)8 weeks of Stress Education Group (SE). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Based Stress Reduction MBSR InterventionMBSR is an 8-week group-based course developed by Jon Kabat-Zinn (1990) and colleagues at the University of Massachusetts' Center for Mindfulness. Weekly 2.5 hour long classes are given once a week, as well as one day-long weekend class. The classes instruct participants in the theory and practice of several forms of mindfulness meditation, breathing awareness, and mindfulness stretching exercises. Teaching of the theory of mindfulness and experiential practice are both utilized during weekly classes and at-home CD-guided practice sessions. | Behavioural | Mindfulness Based Stress Reduction Group |
| Stress Education Control Condition (SE)Stress Education (SE) was designed to provide an active comparator condition that does not include overlapping active components of mindfulness meditation with MBSR. It will also be delivered over 8-weekly, in-person, 2.5 hour group sessions of the same size (n=4 to 6). In SE, participants receive extensive information about stress and health, but will not receive any MBSR or other mind-body training. Instead, stress relevant psycho-educational information will be taught. | Behavioural | Stress Education Group |
Primary outcome
Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learning
Time frame: Experimental 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 learning
Time frame: Experimental 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.
1 secondary outcome
Change in Skin Conductance Response (SCR).
Time frame: Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: Yes. The primary cleaned deidentified dataset 12 months after database lock or primary publication or whatever comes first
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi Simon, MD principal investigator
NYU Langone Health
Candace Raio, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Stress Reduction MBSR Intervention in people with Generalized Anxiety Disorder, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-post changes in fMRI measures of functional activation in the fear extinction network during fear extinction learning (time frame: Experimental Days 1 & 2 (Visit 2 & 3) and Experimental Days 3 & 4 (Visit 9 & 10)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.