Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans

This study is not yet open for participant recruitment.
Verified March 2013 by VA Connecticut Healthcare System
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT01521442
First received: January 19, 2012
Last updated: March 26, 2013
Last verified: March 2013
  Purpose

The primary objective of the current study is to establish the safety and acceptability of Mindful Yoga Therapy as an adjunctive treatment for posttraumatic stress disorder (PTSD) among Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans. The current study also seeks to establish preliminary efficacy of Mindful Yoga Therapy for reduction of symptoms of PTSD and explore heart rate variability as a mechanism of therapeutic action.


Condition Intervention Phase
PTSD
Behavioral: Mindful Yoga Therapy
Behavioral: Wait-list Control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindful Yoga Therapy as an Adjunctive Treatment for PTSD Among OEF/OIF Veterans: A Pilot Study

Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • Clinician Administered PTSD Scale (CAPS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The "gold standard" measure of frequency and intensity of PTSD symptoms.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Behavioral: Mindful Yoga Therapy
Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
Arm 2
12-week delay before beginning Mindful Yoga Therapy treatment which will consist of 12 sessions of Mindful Yoga Therapy delivered two times per week for 75 minutes each.
Behavioral: Wait-list Control
Participants will receive Mindful Yoga Therapy intervention after 12 weeks from being enrolled. Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • OEF/OIF/OND Veteran
  • Ages 18-45
  • Currently enrolled in active PTSD treatment
  • Meet criteria for PTSD
  • Veteran with combat exposure during deployment

Exclusion Criteria:

  • Current psychotic disorder or bipolar disorder
  • Current use of beta-blocker medication
  • Current regular yoga or meditation practice in the past month
  • Significant limitations or injuries
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521442

Contacts
Contact: Rebecca A Czlapinski, M.A. 203.932.5711 ext 3357 rebecca.czlapinski@va.gov

Locations
United States, Connecticut
VA Connecticut Healthcare System Not yet recruiting
West Haven, Connecticut, United States, 06516
Contact: Rebecca A Czlapinski, M.A.    203-932-5711 ext 3357    rebecca.czlapinski@va.gov   
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Alicia Heapy, Ph.D. VA Connecticut Healthcare System
  More Information

No publications provided

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01521442     History of Changes
Other Study ID Numbers: 01540
Study First Received: January 19, 2012
Last Updated: March 26, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Connecticut Healthcare System:
PTSD
Yoga
Complementary and Alternative Medicine (CAM)

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

ClinicalTrials.gov processed this record on April 16, 2014