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Strength and Awareness in Action

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717547
First Posted: October 30, 2012
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Lisa Brenner, VA Office of Research and Development
  Purpose
The aims of this research study are to 1) assess the acceptability and feasibility of conducting a yoga-based intervention for Veterans receiving care at a Veterans Affairs Medical Center, and 2) obtain preliminary data regarding the effect of the intervention on Veteran's mental health.

Condition Intervention
Stress Disorders Behavioral: Yoga-based treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Strength and Awareness in Action

Further study details as provided by Lisa Brenner, VA Office of Research and Development:

Primary Outcome Measures:
  • Change in Psychological Distress [ Time Frame: Change from baseline to approximately 8 weeks ]
    Change in OQ 45 Scores pre and post intervention


Secondary Outcome Measures:
  • Change in Acceptability [ Time Frame: Change in baseline up to 8 weeks post ]
    To assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire


Enrollment: 42
Actual Study Start Date: June 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yoga
Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.
Behavioral: Yoga-based treatment

Detailed Description:
Since October of 2001, approximately over 2 million troops have been deployed in the Global War on Terror. Many service members are returning with both physical injuries and mental health conditions. High rates of both post traumatic stress disorder (PTSD) and/or mild traumatic brain injury (mTBI) and associated symptoms have been noted. It has been estimated that approximately 18-20% of returning service members meet criteria for PTSD and that 11-23% of veterans have a history of mTBI. It has been well established in the research literature that these two conditions frequently co-occur. While there is a dearth of evidence-based treatment for co-occurring PTSD and mTBI, it has been suggested that best practices entail treating presenting symptoms (hyperarousal, hypo-arousal, emotional reactivity, irritability, depression, anxiety, concentration problems) regardless of etiology. Yoga may be particularly well-suited to treating returning servicemen as data suggests that core symptoms that develop with a history of trauma exposure (e.g: hyperarousal; hypoarousal; emotional reactivity; anxiety, irritability), are physiologically based, somatically experienced and often not amenable to change through talking alone. In addition, yoga may assist with dysregulation often associated with mental health and physical conditions, and facilitate the development of mindfulness skills. Research suggests that that moment-to-moment awareness of present experience may decrease emotional reactivity and anxiety, and increase the capacity for self-regulation. Mindfulness skills have also been associated with: building resilience in the midst of stress; allowing one to better cope with physical discomfort; decreasing anxiety and depression; decreasing reactivity. All of these areas are relevant to improving the health and well-being of Veterans.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veterans receiving care by a primary care provider at DVAMC
  • Between the ages of 18 and 50
  • Able to provide informed consent
  • Able to adequately answer comprehension questions
  • Documented VA primary care provider medical clearance to participate in the study as noted on the medical clearance form

Exclusion Criteria:

  • Veterans younger than 18, or older than 50 years of age
  • Inability to provide informed consent
  • Inability to answer comprehension questions
  • Meet criteria for active substance dependence, excluding Cannabis dependence as determined by clinical interview
  • Identification of active psychosis as determined by clinical interview
  • Documentation on the medical clearance form by VA primary care provider which suggests barriers to Veteran participation
  • Veterans whom have sustained an amputation and/or whom have limited physical mobility as documented by the VA primary care provider
  • Veterans already participating in an ongoing yoga practice of up to two times weekly
  Contacts and Locations
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): NCT01717547


Locations
United States, Colorado
Denver Veterans Affairs Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Investigators
Principal Investigator: Lisa Brenner, PhD VA ECHCS
  More Information

Additional Information:
Responsible Party: Lisa Brenner, Director, VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01717547     History of Changes
Other Study ID Numbers: 12-0641
First Submitted: August 29, 2012
First Posted: October 30, 2012
Last Update Posted: May 15, 2017
Last Verified: May 2017

Keywords provided by Lisa Brenner, VA Office of Research and Development:
Veterans
Yoga
Stress