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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01462045
First received: October 7, 2011
Last updated: December 15, 2014
Last verified: December 2014
  Purpose

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.


Condition Intervention
Stress Disorders, Post-Traumatic
Behavioral: Mindfulness-based exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cortisol [ Time Frame: baseline and 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 29
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Group
Participants who are screened positive for PTSD and participate in the series of 16 standardized, semiweekly 60-minute mindfulness-based exercise sessions. The intervention consists of stretching and balancing movements combined with breathing and a focus on mindfulness.Over the course of 8 weeks, the intensity of the exercise increases, but the sequence of the movements is the same.
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.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462045

Locations
United States, New Mexico
The University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Mark R Burge, MD University of New Mexico
  More Information

Publications:
Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01462045     History of Changes
Other Study ID Numbers: CTSC027-2
Study First Received: October 7, 2011
Results First Received: June 5, 2013
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of New Mexico:
Exercise
Stress
PTSD
Mindfulness
Breathing
Cortisol

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2015