Live Video Mind-Body Treatment to Prevent Persistent Symptoms Following Mild Traumatic Brain Injury: Protocol for a Mixed-Methods Study (Preprint)
BACKGROUND Every year, approximately 42 million people suffer a mild traumatic brain injury (mTBI, aka concussion), with particularly high rates among college-age individuals. A substantial proportion (44%-64%) go on to develop persistent symptoms that are challenging to treat, costly, and associated with significant disability. Anxiety has emerged as risk factor for progression from acute to persistent mTBI symptoms. OBJECTIVE This study aims to develop, adapt, and establish the feasibility of the Toolkit for Optimal Recovery after Concussions (TOR-C), an innovative mind-body program aimed at preventing persistent symptoms among young adults with mTBI and co-morbid anxiety. Here we describe the proposed study design, methodology, measurement, and treatment manuals. METHODS In phase 1 we will conduct individual, live video qualitative interviews (up to N=20) with college-age individuals with mTBI and comorbid anxiety to inform adaptation of the intervention and study procedures. In phase 2, we will conduct an open pilot of the live video TOR-C (N=5) with exit interviews to explore initial feasibility, acceptability, and credibility of the program and to refine study procedures. In phase 3 we will conduct a feasibility randomized controlled trial (N= 50) of the TOR-C versus a health education control (Health Enhancement for Concussions; HE-C), both delivered via live video, to establish 1) feasibility of recruitment procedures (screening, eligibility, enrollment) and data collection; 2), feasibility, credibility, and acceptability of the live video TOR-C and HE-C (adherence, retention, fidelity, satisfaction) following pre-specified benchmarks, and 3) a signal of improvement in outcomes. RESULTS Phase 1 of the study was approved by the Massachusetts General Hospital Institutional Review Board. Study completion is anticipated by early 2025. CONCLUSIONS We will develop and test the first mind-body intervention focused on prevention of persistent symptoms following mTBI in young adults with comorbid anxiety problems. It will allow us to establish feasibility markers in post-concussive symptoms, anxiety, disability, and fear avoidance, to inform a future efficacy trial of TOR-C vs. the HE-C and subsequent implementation.