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

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ClinicalTrials.gov Identifier: NCT01462045
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : December 15, 2014
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
University of New Mexico

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Behavioral: Mindfulness-based exercise Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score [ Time Frame: Baseline and 8 weeks ]
    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 :
  1. Cortisol [ Time Frame: baseline and 8 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01462045


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

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Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01462045    
Other Study ID Numbers: CTSC027-2
First Posted: October 28, 2011    Key Record Dates
Results First Posted: December 15, 2014
Last Update Posted: January 6, 2015
Last Verified: December 2014
Keywords provided by University of New Mexico:
Exercise
Stress
PTSD
 Mindfulness
Breathing
Cortisol
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders