Efficacy Study of Mindfulness-Based Exercise for Posttraumatic Stress Disorder (PTSD)
This trial is active, not recruiting.
|Condition||stress disorders, post-traumatic|
|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.
|Endpoint classification||efficacy study|
|Intervention model||crossover assignment|
time frame: Change from baseline in PCL-C symptom severity at 8 weeks
time frame: Change from baseline in cortisol levels at 8 weeks
Male or female participants at least 21 years old.
- 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).
- 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
|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).|
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