Strength and Awareness in Action: an Intervention for Post-Acute TBI Headaches (SAA-TBI)
Condition: Traumatic Brain Injury; Post-concussive Headaches
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Headache
Study type: Interventional

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) 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.
    

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, 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.
    

Intervention name(s): SAA-TBI
Intervention type(s): Behavioral
Intervention description(s): Yoga twice a week for 75 minutes for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Yoga; Veterans; Traumatic Brain Injury; Post-concussive Headaches; Post-concussive Symptoms