JMIR Publications

ABSTRACT

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 (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.