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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01462045
First received: October 7, 2011
Last updated: September 10, 2012
Last verified: March 2012
History of Changes
  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: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 33
Study Start Date: October 2011
Estimated 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 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.

Detailed Description:

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).

  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
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

No publications provided

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
Last Updated: September 10, 2012
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 May 23, 2013