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NCT04288830 · ClinicalTrials.gov registry record · NA
Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity
A NA study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 63
- Enrollment target
NCT04288830: Completed NA study, sponsored by Johns Hopkins University.
NCT04288830 is a NA study that has completed, run by Johns Hopkins University. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04288830, a NA study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 63 participants
- Enrollment target
Study Summary
The standard of care for PTSD involves both psychotherapy and pharmacotherapy, but treatment resistance is common. The discovery of effective complementary treatment approaches would have major implications for patients with PTSD. Mindfulness meditation and related practices have been studied intensively in recent years for a variety of psychiatric illnesses, including depression, generalized anxiety disorder, and PTSD. Studies in PTSD suggest that mindful meditation holds promise. For example, mindfulness-based stress reduction (MBSR) has shown effectiveness for reducing symptom severity and improving mental-health related quality of life in combat-exposed veterans and child survivors of sexual abuse. Mechanistically, mindfulness meditation appears to counteract the types of functional changes that have been identified in the brains of patients with PTSD. In particular, while PTSD symptoms are associated with decreased activation of the prefrontal cortex (PFC) and increased amygdala activity, mindfulness meditation is associated with increased PFC activation and decreased amygdala activation. Other physiological effects of mindfulness meditation in patients with PTSD are not fully defined. However, available data suggest that it leads to a normalization of vagal tone and plasma cortisol levels, which are known to be abnormal in patients with chronic PTSD. Research utilizing validated and standardized pre- and post- PTSD outcome measures, in addition to pre- and post- physiologic variables such a vagal tone, plasma cortisol and catecholamine levels, may better the understandings of physiological effects of mindfulness medication.
Primary Outcome
Score on the PTSD Symptom Checklist for DSM-5. The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. Items on the PCL-5 correspond with DSM-5 criteria for PTSD. The PCL-5 can be used to quantify and monitor symptoms over time, to screen individuals for PTSD, and to assist in making a provisional or temporary diagnosis of PTSD.
Interventions
- BEHAVIORAL Aerobic Exercise
- BEHAVIORAL Tai Chi Moving Mindfulness Meditation and Resilience Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2022-07-27 |
| Phase | NA |
What the finished NCT04288830 record still lists
NCT04288830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Aerobic Exercise is the first listed.
NCT04288830 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04288830 about?
NCT04288830 is a clinical study titled "Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity". The standard of care for PTSD involves both psychotherapy and pharmacotherapy, but treatment resistance is common. The discovery of effective complementary treatment approaches would have major implications for patients with PTSD. Mindfulness meditation and related practices have been studied intens...
What is the current status of trial NCT04288830?
This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2021-10-15. Estimated completion is 2022-07-27.
What interventions are being tested in trial NCT04288830?
The interventions under investigation include: Aerobic Exercise (BEHAVIORAL), Tai Chi Moving Mindfulness Meditation and Resilience Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT04288830?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04288830's enrollment target sits among peer trials
63 1157th of 2000 higher than 844 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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