Jonathan Greenberg, Nadine S Levey, Molly Becker, Gloria Y Yeh, Joseph T Giacino, Grant Iverson, Noah D Silverberg, Robert A Parker, Ana-Maria Vranceanu
{"title":"脑震荡后最佳恢复工具包的可行性随机对照试验：预防患有焦虑症的年轻成年人持续出现脑震荡症状的实时视频计划。","authors":"Jonathan Greenberg, Nadine S Levey, Molly Becker, Gloria Y Yeh, Joseph T Giacino, Grant Iverson, Noah D Silverberg, Robert A Parker, Ana-Maria Vranceanu","doi":"10.1016/j.apmr.2024.10.011","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Single-blind, 2-arm, randomized controlled trial.</p><p><strong>Setting: </strong>Academic medical center in the US Northeast.</p><p><strong>Participants: </strong>Fifty young adults (ages 18-35) with a recent concussion (3-10 weeks prior) and anxiety (≥5 on the GAD7 questionnaire).</p><p><strong>Interventions: </strong>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 (e.g., sleep, nutrition) without skills.</p><p><strong>Main outcome measures: </strong>Primary: feasibility outcomes (e.g., recruitment, credibility, expectancy, acceptability, safety, feasibility of assessments, fidelity, satisfaction, TOR-C homework adherence) with a-priori-set benchmarks. Secondary: intervention outcomes were concussion symptoms (PCSS), physical function (WHODAS), anxiety (GAD7/HAD-A), depression (HADS-D) and pain (NRS). TOR-C mechanistic targets were pain catastrophizing (PCS), mindfulness (CAMS-R), fear avoidance (FAB-TBI), limiting behavior and all-or-nothing behavior (BRIQ).</p><p><strong>Results: </strong>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 following TOR-C were significantly associated with improvements in at least one outcome.</p><p><strong>Conclusion: </strong>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 vs. HE-C.</p>","PeriodicalId":8313,"journal":{"name":"Archives of physical medicine and rehabilitation","volume":" ","pages":""},"PeriodicalIF":3.6000,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A 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.\",\"authors\":\"Jonathan Greenberg, Nadine S Levey, Molly Becker, Gloria Y Yeh, Joseph T Giacino, Grant Iverson, Noah D Silverberg, Robert A Parker, Ana-Maria Vranceanu\",\"doi\":\"10.1016/j.apmr.2024.10.011\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>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.</p><p><strong>Design: </strong>Single-blind, 2-arm, randomized controlled trial.</p><p><strong>Setting: </strong>Academic medical center in the US Northeast.</p><p><strong>Participants: </strong>Fifty young adults (ages 18-35) with a recent concussion (3-10 weeks prior) and anxiety (≥5 on the GAD7 questionnaire).</p><p><strong>Interventions: </strong>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 (e.g., sleep, nutrition) without skills.</p><p><strong>Main outcome measures: </strong>Primary: feasibility outcomes (e.g., recruitment, credibility, expectancy, acceptability, safety, feasibility of assessments, fidelity, satisfaction, TOR-C homework adherence) with a-priori-set benchmarks. Secondary: intervention outcomes were concussion symptoms (PCSS), physical function (WHODAS), anxiety (GAD7/HAD-A), depression (HADS-D) and pain (NRS). TOR-C mechanistic targets were pain catastrophizing (PCS), mindfulness (CAMS-R), fear avoidance (FAB-TBI), limiting behavior and all-or-nothing behavior (BRIQ).</p><p><strong>Results: </strong>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 following TOR-C were significantly associated with improvements in at least one outcome.</p><p><strong>Conclusion: </strong>Findings provide strong support for the feasibility of TOR-C and HE-C, and preliminary evidence for improvements in mechanistic targets and outcomes. 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A 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.
Setting: Academic medical center in the US Northeast.
Participants: Fifty young adults (ages 18-35) with a recent concussion (3-10 weeks prior) and anxiety (≥5 on the GAD7 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 (e.g., sleep, nutrition) without skills.
Main outcome measures: Primary: feasibility outcomes (e.g., recruitment, credibility, expectancy, acceptability, safety, feasibility of assessments, fidelity, satisfaction, TOR-C homework adherence) with a-priori-set benchmarks. Secondary: intervention outcomes were concussion symptoms (PCSS), physical function (WHODAS), anxiety (GAD7/HAD-A), depression (HADS-D) and pain (NRS). TOR-C mechanistic targets were pain catastrophizing (PCS), mindfulness (CAMS-R), fear avoidance (FAB-TBI), limiting behavior and all-or-nothing behavior (BRIQ).
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 following TOR-C were significantly associated with improvements in at least one outcome.
Conclusion: 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 vs. HE-C.
期刊介绍：
The Archives of Physical Medicine and Rehabilitation publishes original, peer-reviewed research and clinical reports on important trends and developments in physical medicine and rehabilitation and related fields. This international journal brings researchers and clinicians authoritative information on the therapeutic utilization of physical, behavioral and pharmaceutical agents in providing comprehensive care for individuals with chronic illness and disabilities.
Archives began publication in 1920, publishes monthly, and is the official journal of the American Congress of Rehabilitation Medicine. Its papers are cited more often than any other rehabilitation journal.
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