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

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 50

- 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 >56 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 50 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.