Clinical trial NCT04288830: Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity
Official title: Evaluation of a Tai Chi Resilience Training Program on Objective and Subjective Measures of Post Traumatic Stress Disorder Severity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Tai Chi
Aerobic Exercise
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Post-traumatic stress disorder (PTSD) affects an estimated 4.7% of the United States population every year, leading to increased rates of disability, suicide, substance use, and interpersonal difficulties. Mindfulness interventions for PTSD offer a low-cost, repeatable method that has the potential to induce fear extinction, and that has no known side effects. While several studies have reported the efficacy of mindfulness meditation and related mind-body exercises to reduce self-reported PTSD symptoms, little is known about the physiologic changes associated with mindfulness interventions. The present study seeks to evaluate the effects of a mind-body mindfulness intervention (tai chi) on subjective reports of PTSD symptoms, as well as physiologic correlates of PTSD in a population of law enforcement officers. Tai chi was chosen because its focus on awareness of physical movements is expected to provide an easier mindfulness target, as compared to traditional seated meditation. It is well documented that patients with PTSD, who frequently struggle with intrusive trauma-related memories, are often unable to attend to current circumstances, a problem that leads to exacerbation of symptoms. While there are promising preliminary data suggesting that tai chi leads to improvements in self-reported symptoms of PTSD, there are no data regarding the effects of tai chi on objective endocrine, physiological, and behavioral measures of PTSD.

The investigators hypothesize that the use of the mind-body practice of tai chi will lead to reductions in subjective self-report measures of PTSD as well a normalization of objective physiological correlates of PTSD. In particular, it is hypothesized that the efficacy of tai chi in the treatment of PTSD is hypothesized to be achieved by facilitating fear extinction and augmenting stress resilience through improved integration of mindfulness practices with daily physical activities. To test this hypothesis, the investigators propose the following specific aims:

• Specific Aim 1: To determine the self-reported symptom changes, behavioral changes, and physiological effects that take place during an 8-week intervention of simplified Tai Chi Moving Mindfulness Meditation and Resilience Training (TCMMMRT) in a population of police officers with and without self-reported PTSD. Results from these two groups will also be compared to a control group engaging in aerobic exercise.

* Self-reported outcome measures: Brief Pain Inventory (BPI) short form, Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI), PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM-V) (PCL-5), and Canadian Occupational Performance Measure (COPM).
* Physiological outcome measures: Mobile Acoustic startle Reflex-monitoring System (MARS) measures, heart rate variability (HRV), cortisol measurements, and actigraphy to monitor sleep patterns and activity levels.

Eligibility criteria: Inclusion Criteria:

For inclusion as a healthy control or a participant with PTSD:

* working in law enforcement
* between the ages of 18 and 65
* Both men and women

For inclusion as a participant with PTSD:

* previously diagnosed with PTSD by a medical professional (For inclusion in the PTSD group)
* Must meet criteria for PTSD as determined by the PCL-5 instrument on the day of initial assessment.

Exclusion criteria:

* taking sedative or stimulant drugs daily
* physical illness, injury, or disability preventing safe execution of low impact aerobic exercise

Primary outcomes:
measure: Change in PCL-5 Score
timeFrame: Assessed on Day 1, Day 56, Day 112, and Day 168
Secondary outcomes:
measure: Change in BPI score
timeFrame: Assessed on Day 1, Day 56, Day 112, and Day 168
measure: Change in BDI score
timeFrame: Assessed on Day 1, Day 56, Day 112, and Day 168
measure: Change in PSQI score
timeFrame: Assessed on Day 1, Day 56, Day 112, and Day 168
measure: Change in COPM score
timeFrame: Assessed on Day 1, Day 56, Day 112, and Day 168
measure: Change in Salivary Cortisol
timeFrame: Assessed on Day 1, Day 56, Day 112, and Day 168
measure: Change in Heart Rate Variability
timeFrame: Assessed on Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112, and Day 168
measure: Change in Acoustic Blink Response
timeFrame: Assessed on Days 1, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 105, 112, and Day 168
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Una McCann
role: PRINCIPAL_INVESTIGATOR
References: