Trial Outcomes & Findings for Efficacy Study of Mindfulness-Based Exercise for Posttraumatic Stress Disorder (PTSD) (NCT NCT01462045)

Nurse volunteers were recruited from the University of New Mexico Hospital through advertisement,between September 1, 2011 and March 31, 2012.

Participants gave their informed written consent before participation. Inclusion criteria were age greater than 18 years and employment as a nurse at the University of New Mexico (UNM) Hospital. Exclusion criteria included an inability to participate in the exercise program, or current use of systemic glucocorticoid.

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

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.

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.