- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01717547
Strength and Awareness in Action
October 31, 2018 updated by: Lisa Brenner, VA Eastern Colorado Health Care System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80220
- Denver Veterans Affairs Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Psychological Distress
Time Frame: Change from baseline to approximately 8 weeks
|
Change in OQ 45 Scores pre and post intervention
|
Change from baseline to approximately 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Acceptability
Time Frame: Change in baseline up to 8 weeks post
|
To assess participant satisfaction post-intervention using the Client Satisfaction Questionnaire
|
Change in baseline up to 8 weeks post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lisa Brenner, PhD, VA ECHCS
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 29, 2012
First Submitted That Met QC Criteria
October 25, 2012
First Posted (Estimate)
October 30, 2012
Study Record Updates
Last Update Posted (Actual)
November 2, 2018
Last Update Submitted That Met QC Criteria
October 31, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-0641
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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