Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia; Monash-Epworth Rehabilitation Research Centre, Melbourne, Australia.
Turner Institute for Brain and Mental Health, School of Psychological Sciences, Monash University, Melbourne, Australia; Monash-Epworth Rehabilitation Research Centre, Melbourne, Australia.
Ann Phys Rehabil Med. 2023 Oct;66(7):101777. doi: 10.1016/j.rehab.2023.101777. Epub 2023 Oct 25.
Despite clinical guidelines recommending an interdisciplinary approach to persisting post-concussion symptom (PPCS) management, evaluations of interdisciplinary interventions remain scant.
This pilot study aimed to explore the feasibility and preliminary efficacy of an interdisciplinary intervention for PPCSs.
A single-case experimental design with randomisation to multiple baselines (2, 4, or 6 weeks) was repeated across 15 participants (53% female) with mild traumatic brain injury (mean age 38.3 years, SD 15.7). The 12-week treatment incorporated psychology, physiotherapy, and medical interventions. Feasibility outcomes included recruitment and retention rates, adverse events, treatment adherence and fidelity. Patient-centred secondary outcomes included the Rivermead Post-Concussion Symptoms Questionnaire (RPQ), assessed 3 times per week during the baseline and treatment phases, and at the 1- and 3-month follow-ups. Other secondary outcomes included measures of mood, sleep and fatigue, physical functioning, health-related quality of life, illness perceptions, and goal attainment. Changes in PPCSs were evaluated using systematic visual analysis and Tau-U. Clinically significant changes in secondary outcomes were explored descriptively.
16/26 individuals assessed for eligibility were enroled (61% recruitment rate); 15 completed the post-treatment follow-ups, and 13 completed the 1- and 3-month follow-up assessments (81% retention rate). High treatment adherence and competence in delivering treatments was observed. Moderate-large effect sizes for reducing PPCSs were observed in 12/15 cases, with 7/15 reaching statistical significance. Improvements were maintained at the 1- and 3-month follow-ups and were accompanied by reductions in fatigue, sleep difficulties, and mood symptoms, and changes in illness perceptions. All participants had clinically significant improvements in at least 1 outcome, with 81% of individual therapy goals achieved.
This pilot study provided preliminary support for a subsequent randomised controlled trial (RCT), with satisfactory recruitment, retention, treatment compliance, and treatment fidelity. Improvement was evident on participant outcomes including symptom reduction and goal attainment, suggesting that progressing to a phase-II RCT is worthwhile. Findings highlight the potential benefit of individualized interdisciplinary treatments.
尽管临床指南建议采用跨学科方法来管理持续性脑震荡后症状（PPCS），但对跨学科干预措施的评估仍然很少。
本试点研究旨在探讨针对 PPCS 的跨学科干预措施的可行性和初步疗效。
对 15 名轻度创伤性脑损伤患者（53%为女性，平均年龄 38.3 岁，标准差 15.7 岁）采用随机分组至多个基线（2、4 或 6 周）的单病例实验设计进行重复。12 周的治疗包括心理、物理治疗和医疗干预。可行性结果包括招募和保留率、不良事件、治疗依从性和一致性。以患者为中心的次要结果包括 Rivermead 脑震荡后症状问卷（RPQ），在基线和治疗阶段每周评估 3 次，以及在 1 个月和 3 个月的随访时评估。其他次要结果包括情绪、睡眠和疲劳、身体功能、健康相关生活质量、疾病认知和目标实现的测量。使用系统视觉分析和 Tau-U 评估 PPCS 的变化。探索描述性地评估次要结果中临床显著变化。
评估合格性的 26 人中 16 人入组（61%的招募率）；15 人完成了治疗后随访，13 人完成了 1 个月和 3 个月的随访（81%的保留率）。观察到治疗依从性高，治疗能力强。12/15 例 PPCS 减少的效应量为中度至较大，其中 7/15 例达到统计学意义。在 1 个月和 3 个月的随访中仍有改善，并伴有疲劳、睡眠困难和情绪症状的减少，以及疾病认知的改变。所有参与者在至少 1 项结果中有临床显著改善，81%的个体治疗目标得以实现。
本试点研究为随后的随机对照试验（RCT）提供了初步支持，招募、保留、治疗依从性和治疗一致性均令人满意。参与者的结果包括症状减轻和目标实现，都有明显改善，表明进行二期 RCT 是值得的。研究结果突出了个体化跨学科治疗的潜在益处。
