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Citation
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Betthauser LM, Forster JE, Bortz A, Penzenik M, Hernández TD, Bahraini N, Brenner LA. Contemp. Clin. Trials Commun. 2021; 22: 100762. |
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Abstract
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BACKGROUND: Mild traumatic brain injury (mTBI) is a signature injury sustained by Veterans during recent conflicts. For some, mTBI/concussion is associated with disabling symptoms, including post-concussive headaches (PCH). However, there are limited evidence-based treatments for persistent PCH.
OBJECTIVE: Investigators assessed the feasibility of design elements of a yoga-based interventional trial for PCH among Veterans, as well as the acceptability of the intervention.
METHODS: This randomized controlled acceptability and feasibility trial was implemented using a waitlist-control design. Design elements of interest included: an exercise run-in class; recruitment and retention strategies; and, ecological momentary assessment (EMA) modalities to track headaches and yoga practice. Veteran satisfaction regarding the intervention was also evaluated. A descriptive analysis was conducted on candidate outcomes including PCH, post-concussive symptoms, pain, and daily functioning.
RESULTS: Twenty-seven participants (out of 70 consented and eligible after Study Visit 1) completed each evaluation timepoint and regularly attended yoga sessions, with 89% of these Veterans reporting moderate to high levels of satisfaction with the intervention at study completion. Qualitatively, participants endorsed improvements in headaches, chronic pain, and mood. Feasibility results were mixed. Initial feasibility criterion regarding yoga attendance was not met; however, modifications, such as expansion to an additional clinic site and reduction of in-person yoga sessions with increased encouragement to use study-created online yoga videos improved feasibility of the study design. Participants most frequently used mobile and web-based EMA modalities to track yoga practice.
CONCLUSIONS: Although challenges with feasibility of the study design elements were noted, results suggested acceptability of the yoga-based intervention for Veterans with persistent PCH. Additional exploration regarding the frequency and modality of yoga delivery (e.g., in-person, telehealth) is warranted. IMPACT: Veterans found the yoga-based intervention acceptable, however exploration of novel modalities of intervention delivery will likely be necessary to enhance the feasibility of intervention implementation during future trials.
Language: en |