Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)

Completed · Not applicable

Conditions studied: Traumatic Brain Injury, Post-concussive Headaches

In brief

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) intervention trial (e.g., an exercise run-in to facilitate participant retention); 2) yoga instructor fidelity; and 3) variability estimates for candidate proximal and distal outcomes. Performance of validated measures, including those associated with quality of life, as well as data collected via ecological momentary assessment and pedometry (physical activity) will be evaluated.

Key facts

Study ID

NCT03277859

Run by

VA Eastern Colorado Health Care System

People needed

75

Starts

2017-08-16

Expected to finish

2019-06-30

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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