Status:
COMPLETED
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
Lead Sponsor:
VA Eastern Colorado Health Care System
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Traumatic Brain Injury
Post-concussive Headaches
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The specific aims of the proposed study are to evaluate: 1) the feasibility of design elements of a Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) interventio...
Detailed Description
A signature injury being sustained by Veterans from recent conflicts is mild traumatic brain injury (mTBI). For some, this condition is associated with multiple disabling post-concussive symptoms, inc...
Eligibility Criteria
Inclusion
- Between the ages of 18 and 55
- Able to provide informed consent
- History of mTBI per the Ohio State University TBI-ID (OSU-TBI-ID)
- History of PCH pain (TTH, migraine, or mixed), with onset of pain or increase in previous headache pain having occurred within one month of mTBI as determined by structured examination using criteria outlined in the International Classification of Headache Disorders-3 beta (ICHD-3 beta)
- Duration of PCH pain being greater than one year as determined by structured medical examination
- Score of \>49 on the Headache Impact Test-6 (HIT-6)
- Medical clearance by study provider to participate in yoga protocol
Exclusion
- Younger than 18, or older than 55 years of age
- Active substance dependence, excluding Cannabis dependence (based on local issues regarding the legality of cannabis), as determined by structured clinical interview
- Moderate to severe TBI as determined per the OSU-TBI-ID
- Identification of active psychosis as determined by structured clinical interview
- Failing to receive medical clearance by study provider;
- Inability to participate in the manualized intervention without postures being significantly modified
- Already participating in an ongoing consistent yoga practice (two or more times weekly)
- Involvement in another research interventional trial aimed at addressing pain-related symptoms.
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03277859
Start Date
August 16 2017
End Date
June 30 2019
Last Update
July 23 2019
Active Locations (1)
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1
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States, 80045