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Strength and Awareness in Action

Primary Purpose

Stress Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga-based treatment
Sponsored by
VA Eastern Colorado Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders focused on measuring Veterans, Yoga, Stress

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Denver Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Psychological Distress
Change in OQ 45 Scores pre and post intervention

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2012
Last Updated
October 31, 2018
Sponsor
VA Eastern Colorado Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01717547
Brief Title
Strength and Awareness in Action
Official Title
Strength and Awareness in Action
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Eastern Colorado Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders
Keywords
Veterans, Yoga, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
Yoga-based treatment - manualized group treatment - classes will be held twice per week for approximately 85 minutes for a period of eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga-based treatment
Primary Outcome Measure Information:
Title
Change in Psychological Distress
Description
Change in OQ 45 Scores pre and post intervention
Time Frame
Change from baseline to approximately 8 weeks
Secondary Outcome Measure Information:
Title
Change in Acceptability
Description
To assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire
Time Frame
Change in baseline up to 8 weeks post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Brenner, PhD
Organizational Affiliation
VA ECHCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Denver Veterans Affairs Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mirecc.va.gov/visn19/
Description
VA VISN 19 MIRECC website

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Strength and Awareness in Action

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