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Strength and Awareness in Action

Strength and Awareness in Action

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01717547
Enrollment
42
Registered
2012-10-30
Start date
2012-06-30
Completion date
2014-12-31
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress Disorders

Keywords

Veterans, Yoga, Stress

Brief 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.

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.

Interventions

BEHAVIORALYoga-based treatment

Sponsors

VA Eastern Colorado Health Care System
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Psychological DistressChange from baseline to approximately 8 weeksChange in OQ 45 Scores pre and post intervention

Secondary

MeasureTime frameDescription
Change in AcceptabilityChange in baseline up to 8 weeks postTo assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026