Trial reportArchives of physical medicine and rehabilitation2025
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.
Trial report in Archives of physical medicine and rehabilitation, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Concussion Outcomes 3 Months after an Intervention for Young Adults with Co-Occurring Anxiety: A Randomized Controlled Trial.Journal of integrative and complementary medicine · 2025Trial
- Responsivity of Concussion Symptom Domains to a Mind-Body Intervention for Young Adults With a Recent Concussion and Anxiety: A Pilot RCT.The Journal of head trauma rehabilitationTrial
Corrections and comments
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Authors and funding
9 authors.
Funding
Abstract
objectivesTo 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.
designSingle-blind, 2-arm, randomized controlled trial (RCT).
settingAcademic medical center in the US Northeast.
participantsFifty 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).
interventionsBoth 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 measuresPrimary: 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).
resultsBoth 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.
conclusionsFindings 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.
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