NCT04288830

Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity

Completed NA Last updated 11 April 2023

What this trial tests

NA trial testing Tai Chi Moving Mindfulness Meditation and Resilience Training in Post Traumatic Stress Disorder in 63 participants. Completed in 27 July 2022.

Timeline

15 October 2021

Primary endpoint
27 July 2022

27 July 2022

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	15 October 2021
Primary completion	27 July 2022
Estimated completion	27 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Tai Chi Moving Mindfulness Meditation and Resilience Training
• Aerobic Exercise — full drug profile →

Conditions studied

• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →
• Tai Chi — all drugs for Tai Chi →
• Aerobic Exercise — all drugs for Aerobic Exercise →

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 65, any sex, with Post Traumatic Stress Disorder or Tai Chi. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.