This trial is active, not recruiting.

Condition stress disorders, post-traumatic
Treatment mindfulness-based exercise
Sponsor University of New Mexico
Start date October 2011
End date July 2012
Trial size 33 participants
Trial identifier NCT01462045, CTSC027-2


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
mindfulness-based exercise Mindfulness stretching and breathing exercises
8-week program of mindfulness-based stretching and breathing exercises
(No Intervention)
Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
(No Intervention)
Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.

Primary Outcomes

PCL-C score
time frame: Change from baseline in PCL-C symptom severity at 8 weeks

Secondary Outcomes

time frame: Change from baseline in cortisol levels at 8 weeks

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title The Efficacy of Mindfulness-Based Stretching and Breathing Exercise as a Complementary Therapy for Posttraumatic Stress Disorder: A Prospective Randomized Study
Principal investigator Mark R Burge, MD
Description This study will employ a crossover randomized clinical trial 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 plasma cortisol, the investigators will ask the participants to rate the severity of their PTSD symptoms using the PTSD checklist, civilian version (PCL-C).
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by University of New Mexico.