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

NCT ID: NCT01462045

Last Updated: 2015-01-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-10-31

Brief Summary

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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

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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).

Conditions

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Stress Disorders, Post-Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-based exercise

Intervention Type BEHAVIORAL

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

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Base Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-based exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness stretching and breathing exercises

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of New Mexico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark R Burge, MD

Role: PRINCIPAL_INVESTIGATOR

University of New Mexico

Locations

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The University of New Mexico

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23720785 (View on PubMed)

Other Identifiers

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CTSC027-2

Identifier Type: -

Identifier Source: org_study_id

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