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

NCT04288830 | Completed

• 1 other identifier: IRB00226155
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Tai Chi; Aerobic Exercise

Outcome Measures

Primary Outcomes (1)

• Change in PCL-5 Score

  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.

  Assessed on Day 1, Day 56, Day 112, and Day 168

Secondary Outcomes (7)

• Change in BPI score

  Assessed on Day 1, Day 56, Day 112, and Day 168

• Change in BDI score

  Assessed on Day 1, Day 56, Day 112, and Day 168

• Change in PSQI score

  Assessed on Day 1, Day 56, Day 112, and Day 168

• Change in COPM score

  Assessed on Day 1, Day 56, Day 112, and Day 168

• Change in Salivary Cortisol

  Assessed on Day 1, Day 56, Day 112, and Day 168

Study Arms (2)

TCMMMRT First

EXPERIMENTAL

Participants will perform an instructor-led mind-body exercise regimen 1 day per week during this arm of the study for a total of 8 weeks. Home practice will be logged. At the completion of the TCMMMRT Condition, participants will perform an instructor-led low impact aerobic exercise regimen 1 day per week for a total of 8 weeks. Home exercise will be logged.

Behavioral: Tai Chi Moving Mindfulness Meditation and Resilience Training; Behavioral: Aerobic Exercise

Aerobic Exercise First

ACTIVE COMPARATOR

Participants will perform an instructor-led low impact aerobic exercise regimen 1 day per week during this arm of the study for a total of 8 weeks. Home exercise will be logged. At the completion of the aerobic exercise condition, participants will perform an instructor-led mind-body exercise regimen 1 day per week for a total of 8 weeks. Home practice will be logged.

Behavioral: Tai Chi Moving Mindfulness Meditation and Resilience Training; Behavioral: Aerobic Exercise

Interventions

Tai Chi Moving Mindfulness Meditation and Resilience Training BEHAVIORAL

Low-impact mind-body exercise adapted from traditional tai chi.

Aerobic Exercise First; TCMMMRT First

Aerobic Exercise BEHAVIORAL

Low-impact aerobic exercise, led by instructor

Aerobic Exercise First; TCMMMRT First

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• working in law enforcement
• between the ages of 18 and 65
• Both men and women
• Must meet criteria for PTSD as determined by the PCL-5 instrument on the day of initial assessment.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Una McCann

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: October 15, 2021
• Primary Completion: July 27, 2022
• Study Completion: July 27, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)