CClinicalTrials.gg
CompletedNCT01717547Updated Nov 2, 2018

Strength and Awareness in Action

An interventional study of Yoga-based treatment in Stress Disorders, sponsored by VA Eastern Colorado Health Care System. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by VA Eastern Colorado Health Care System · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Stress Disorders

Keywords

  • Veterans
  • Yoga
  • Stress
03

In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

VA Eastern Colorado Health Care System is the lead sponsor of 49 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralYoga-based treatment
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What researchers measure

Primary outcomes

  1. Change in Psychological Distress

    Change in OQ 45 Scores pre and post intervention

    Time frame: Change from baseline to approximately 8 weeks

Secondary outcomes

  1. Change in Acceptability

    To assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire

    Time frame: Change in baseline up to 8 weeks post

07

Study locations

1 site
  • Denver Veterans Affairs Medical Center
    Denver, Colorado 80220, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01717547
Lead sponsor
VA Eastern Colorado Health Care System
Responsible party
Lisa Brenner (Director, VA Eastern Colorado Health Care System) — Principal investigator
First posted
Oct 30, 2012
Start date
Jun 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Nov 2, 2018

Study contacts

Lisa Brenner, PhD
principal investigator · VA ECHCS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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