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

NCT01462045 | Completed Results

• 1 other identifier: CTSC027-2
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Disorders, Post-Traumatic

Keywords

Exercise; Stress; PTSD; Mindfulness; Breathing; Cortisol

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in PTSD Checklist - Civilian Version (PCL-C) Score

  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.

  Baseline and 8 weeks

Secondary Outcomes (1)

• Cortisol

  baseline and 8 weeks

Study Arms (3)

Exercise Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.

Base Group

NO INTERVENTION

Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.

Interventions

Mindfulness-based exercise BEHAVIORAL

8-week program of mindfulness-based stretching and breathing exercises

Also known as: Mindfulness stretching and breathing exercises

Exercise Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• employed as a nurse

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead

Study Sites (1)

The University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (1)

• 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.

  PMID: 23720785 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity; Respiratory Aspiration

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Sang Hwan Kim, PhD/Lead Investigator
• Organization: University of New Mexico

sanghk@gmail.com

5057954545

Study Officials

• Mark R Burge, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 28, 2011
• Study Start: October 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 6, 2015
• Results First Posted: December 15, 2014

Record last verified: 2014-12

Locations

US (1)