Efficacy Study of Mindfulness-Based Exercise for Posttraumatic Stress Disorder (PTSD)
Recruitment status was Active, not recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Efficacy of Mindfulness-Based Stretching and Breathing Exercise as a Complementary Therapy for Posttraumatic Stress Disorder: A Prospective Randomized Study|
- PCL-C score [ Time Frame: Change from baseline in PCL-C symptom severity at 8 weeks ] [ Designated as safety issue: No ]Participants will rate the severity of their PTSD symptoms using PCL-C.
- Cortisol [ Time Frame: Change from baseline in cortisol levels at 8 weeks ] [ Designated as safety issue: No ]Plasma cortisol samples will be collected at 8:00 AM.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2012|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Exercise Group
Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
Behavioral: Mindfulness-based exercise
8-week program of mindfulness-based stretching and breathing exercises
Other Name: 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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462045
|United States, New Mexico|
|The University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||Mark R Burge, MD||University of New Mexico|