Efficacy Study of Mindfulness-Based Exercise for Posttraumatic Stress Disorder (PTSD)

The Efficacy of Mindfulness-Based Stretching and Breathing Exercise as a Complementary Therapy for Posttraumatic Stress Disorder: A Prospective Randomized Study

This study will explore the relationship between changes in plasma cortisol and symptom reduction resulting from individuals with posttraumatic stress disorder (PTSD) participating in an 8-week program of mindfulness-based stretching and breathing exercise. The investigators hypothesize that at the completion of participation in the 8-week program, exercise-induced symptom reduction will be associated with changes in cortisol levels.

Study Overview

• Status: Completed
• Conditions: Stress Disorders, Post-Traumatic
• Intervention / Treatment: Behavioral: Mindfulness-based exercise

Detailed Description

This study will employ an intent-to-treat design to evaluate the relationship between exercise-induced posttraumatic stress disorder (PTSD) symptom reduction and exercise-induced changes in cortisol level. The participants consist of nurses and the intervention will be conducted at the Clinical and Translational Science Center of the University of New Mexico. The study was approved by the Human Research Protections Office of the university. Nurses who are screened positively for PTSD will be randomly assigned to either control or exercise group. At baseline and in weeks 4, 8, 12 and 16, immediately after the phlebotomy for serum cortisol, the investigators will ask the participants to rate the severity of their PTSD symptoms using the PTSD Checklist (PCL).

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • The University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• employed as a nurse
• PCL-C score of at least 28 with at least a score of 3 on one or more items for inclusion in the PTSD symptomatic groups (EX and CON)
• PCL-C score of 27 or lower for inclusion in the non-PTSD symptomatic group (BASE).

Exclusion Criteria:

• the inability to complete the exercise program
• a positive answer to any of the seven screening questions on the Physical Activity Readiness Questionnaire (PAR-Q)
• current use of prednisone or other forms of cortisone medication excluding cortisone in inhaled form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Group; Participants who are screened positive for PTSD and participate in the series of 16 standardized, semiweekly 60-minute mindfulness-based exercise sessions. The intervention consists of stretching and balancing movements combined with breathing and a focus on mindfulness.Over the course of 8 weeks, the intensity of the exercise increases, but the sequence of the movements is the same.	Behavioral: Mindfulness-based exercise; 8-week program of mindfulness-based stretching and breathing exercises; Other Names: Mindfulness stretching and breathing exercises
No Intervention: Control Group; Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
No Intervention: Base Group; Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score	The PCL-C is a 17-item self-report instrument that measures the symptoms of PTSD. A total score, ranging from 17 to 85, is found by summing the scores of the 17 items. Higher values are considered to be a worse outcome. The inclusion criteria in the PTSD symptomatic group is a PCL-C total score of at least 28 with a score of 3 or higher on 1 or more items.To detect a reduction in PTSD symptom severity with a 2-sided 5% significance level and a power of 80%, the mean difference of PCL-C scores of 5.16 or greater requires a sample size of 20 participants for Exercise and Control groups, given an anticipated dropout rate of 10%. Data analyses are conducted using an a priori intention-to-treat approach. The analysis for the between-group differences of the intervention is conducted using t-tests comparing Exercise and Control groups at post-intervention. The analysis for the within-group difference is conducted using repeated measures ANOVA for both groups at baseline and week 8.	Baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortisol	Change from baseline in serum cortisol levels at 8 weeks. Serum cortisol samples were collected at 8:00 Ante Meridian (AM). The changes are calculated from two time points as the values at 8 weeks minus the values at baseline.	baseline and 8 weeks

Collaborators and Investigators

• Sponsor: University of New Mexico
• Investigators: Principal Investigator: Mark R Burge, MD, University of New Mexico

Publications and helpful links

General Publications

• Kim SH, Schneider SM, Bevans M, Kravitz L, Mermier C, Qualls C, Burge MR. PTSD symptom reduction with mindfulness-based stretching and deep breathing exercise: randomized controlled clinical trial of efficacy. J Clin Endocrinol Metab. 2013 Jul;98(7):2984-92. doi: 10.1210/jc.2012-3742. Epub 2013 May 29.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Estimate): January 6, 2015
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: PTSD; Exercise; Stress; Mindfulness; Cortisol; Breathing
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: CTSC027-2