Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
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.
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, including post-concussive headaches (PCH). PCHs are notoriously resistant to
 medication alone, and are associated with increased muscle tension, avoidance of physical
 activities, and anxiety related to having chronic pain. In this study, the feasibility (ease
 of implementation) of the design elements of an interventional trial of Strength and
 Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI) will be explored.
 Yoga is operationalized as a practice involving physical postures, breath awareness,
 breathing exercises and mindfulness meditation. It is conceptualized as having three "active
 ingredients" (i.e., regulation of the autonomic nervous system via physical
 activity/breathing exercises, release of muscular tension associated with headaches, and
 mindfulness/acceptance). The specific aims of the proposed study are to evaluate: 1) the
 feasibility of design elements of an 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. Project aims will be
 evaluated using an experimental design where participants will be block randomized in a
 stratified manner to SAA-TBI or a waitlist using a 1:1 ratio. The waitlist group will
 initially receive 8 weeks of enhanced treatment as usual (ETU). The participants in the
 waitlist condition will be offered SAA-TBI, after the initial group has completed the
 intervention. Both groups of participants will complete multiple measures at baseline and
 after the conclusion of the intervention. Maintenance among the intervention group will also
 be explored. Participants will be asked to complete daily homework documenting their
 headaches and yoga practice outside of class, and be provided with multiple modalities
 (web-based, mobile app, text, or paper and pencil) by which this can be accomplished. In
 specific, the proposed study will evaluate the feasibility of the trial design for an
 accessible, non-pharmacological, yoga-based intervention for chronic PCH pain among Veterans
 with mTBI, with the long-term goal of informing future efficacy trials.
Inclusion Criteria:

 -  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 Criteria:

 -  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.