Feasibility Randomized Controlled Trial of the Toolkit for Optimal Recovery After Concussion: A Live Video Program to Prevent Persistent Concussion Symptoms in Young Adults With Anxiety.

OBJECTIVES

To assess the feasibility of the Toolkit for Optimal Recovery after Concussion (TOR-C), the first mind-body program aiming to prevent persistent concussion symptoms among young adults with anxiety, and an active control (Health Enhancement after Concussion [HE-C]). We also tested preliminary improvements in outcome measures and putative mechanistic targets.

DESIGN

Single-blind, 2-arm, randomized controlled trial (RCT).

SETTING

Academic medical center in the US Northeast.

PARTICIPANTS

Fifty young adults (aged 18-35 years) with a recent concussion (3-10 weeks prior) and anxiety (≥5 on the Generalized Anxiety Disorder-7 [GAD-7] questionnaire).

INTERVENTIONS: Both interventions consisted of four 45-minute 1:1 sessions with a clinician over Zoom. TOR-C (n=25) taught mind-body, cognitive-behavioral, and return-to-activity skills. HE-C (n=25) taught health education (eg, sleep, nutrition) without skills.

MAIN OUTCOME MEASURES: Primary: feasibility outcomes (eg, recruitment, credibility, expectancy, acceptability, safety, feasibility of assessments, fidelity, satisfaction, and TOR-C homework adherence) with a-priori-set benchmarks. Secondary: intervention outcomes were concussion symptoms (Post-Concussion Symptom Scale), physical function (World Health Organization Disability Assessment Scale), anxiety (GAD-7/anxiety subscale of the Hospital Anxiety and Depression Scale), depression (depression subscale of the Hospital Anxiety and Depression Scale) and pain (Numerical Rating Scale). TOR-C mechanistic targets were pain catastrophizing (Pain Catastrophizing Scale), mindfulness (Cognitive and Affective Mindfulness Scale-Revised), fear avoidance (Fear Avoidance Behavior after Traumatic Brain Injury), limiting behavior and all-or-nothing behavior (Behavioral Response to Illness Questionnaire).

RESULTS

Both interventions met all feasibility benchmarks and were associated with significant improvements in outcomes (concussion symptoms, physical function, anxiety, depression, and pain; d=0.44-1.21) and TOR-C mechanistic targets (pain catastrophizing, mindfulness, fear-avoidance, and limiting behavior; Cohen's d=0.41-1.24). Improvements in all-or-nothing behavior were only significant in TOR-C (d=0.52). Improvements in all mechanistic targets except all-or-nothing behavior after TOR-C were significantly associated with improvements in at least one outcome.

CONCLUSIONS

Findings provide strong support for the feasibility of TOR-C and HE-C, and preliminary evidence for improvements in mechanistic targets and outcomes. Findings inform a future fully-powered RCT testing efficacy of TOR-C versus HE-C.