Clinical trial NCT01462045: Efficacy Study of Mindfulness-Based Exercise for Posttraumatic Stress Disorder (PTSD)
Official title: The Efficacy of Mindfulness-Based Stretching and Breathing Exercise as a Complementary Therapy for Posttraumatic Stress Disorder: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post-Traumatic
Keywords: Exercise
Stress
PTSD
Mindfulness
Breathing
Cortisol
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2011-10-28
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Cortisol
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: The University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Mark R Burge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.