Strength and Awareness in Action

NCT ID: NCT01717547

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-12-31

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.

Conditions

Stress Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Yoga

Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.

Group Type: EXPERIMENTAL

Yoga-based treatment

Intervention Type: BEHAVIORAL

Interventions

Yoga-based treatment

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Eastern Colorado Health Care System

FED

Sponsor Role: lead

Responsible Party

Lisa Brenner

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa Brenner, PhD

Role: PRINCIPAL_INVESTIGATOR

VA ECHCS

Locations

Denver Veterans Affairs Medical Center

Denver, Colorado, United States

Countries

United States

Related Links

http://www.mirecc.va.gov/visn19/

VA VISN 19 MIRECC website

Other Identifiers

12-0641

Identifier Type: -

Identifier Source: org_study_id