Clinical trial NCT01717547: Strength and Awareness in Action
Official title: Strength and Awareness in Action
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders
Keywords: Veterans
Yoga
Stress
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2012-10-30
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Psychological Distress
timeFrame: Change from baseline to approximately 8 weeks
Secondary outcomes:
measure: Change in Acceptability
timeFrame: Change in baseline up to 8 weeks post
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Veterans Affairs Medical Center
state: Colorado
Study officials:
affiliation: VA ECHCS
name: Lisa Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: