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NCT05064813 · ClinicalTrials.gov registry record · NA
MBSR Mechanisms in GAD
A NA study of Generalized Anxiety Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT05064813: Recruiting NA study of Generalized Anxiety Disorder, sponsored by NYU Langone Health.
NCT05064813 is a NA study of Generalized Anxiety Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 150 participants, below the 212-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (29% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05064813, a NA study of Generalized Anxiety Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 c
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction MBSR Intervention
- BEHAVIORAL Stress Education Control Condition (SE)
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-11-18 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What NCT05064813 shows while recruiting
NCT05064813 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 212-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness Based Stress Reduction MBSR Intervention is the first listed.
NCT05064813 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05064813 about?
NCT05064813 is a clinical study titled "MBSR Mechanisms in GAD". 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 t...
What is the current status of trial NCT05064813?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-11-18. Estimated completion is 2026-06-30.
What conditions does trial NCT05064813 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder.
What interventions are being tested in trial NCT05064813?
The interventions under investigation include: Mindfulness Based Stress Reduction MBSR Intervention (BEHAVIORAL), Stress Education Control Condition (SE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT05064813?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05064813 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05064813's enrollment target sits among peer trials
150 22nd of 48 higher than 26 of 48 other Generalized Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Anxiety Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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