PDF(Pubmed)
Abstract：
BACKGROUND: Concussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child\'s quality of life while interfering with their participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt to postinjury symptoms, resulting in the greater acceptance of change; reduced stress; and recovery of somatic, emotional, and cognitive symptoms.
OBJECTIVE: The primary objective of this study is to assess the feasibility of conducting a parallel-group (1:1) randomized controlled trial (RCT) to evaluate a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to <18 years. The attention-matched comparator intervention (a math game also used in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with the standard of care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory, and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks after concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention group have different brain-based imaging patterns compared with those randomized to the control group.
METHODS: This study is a double-blind Health Canada-regulated trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week DTx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days after injury) and at 1, 2, and 4 weeks after the injury. A subset of 60 participants will undergo magnetic resonance imaging within 72 hours and at 4 weeks after recruitment to identify the neurophysiological mechanisms underlying the potential benefits from MBI training in adolescents following a concussion.
RESULTS: The recruitment began in October 2022, and the data collection is expected to be completed by September 2024. Data collection and management is still in progress; therefore, data analysis is yet to be conducted.
CONCLUSIONS: This trial will confirm the feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youth at risk of experiencing prolonged postconcussion symptoms and complications.
BACKGROUND: ClinicalTrials.gov NCT05105802; https://classic.clinicaltrials.gov/ct2/show/NCT05105802.
UNASSIGNED: DERR1-10.2196/57226.
OBJECTIVE: The primary objective of this study is to assess the feasibility of conducting a parallel-group (1:1) randomized controlled trial (RCT) to evaluate a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to <18 years. The attention-matched comparator intervention (a math game also used in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with the standard of care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory, and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks after concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention group have different brain-based imaging patterns compared with those randomized to the control group.
METHODS: This study is a double-blind Health Canada-regulated trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week DTx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days after injury) and at 1, 2, and 4 weeks after the injury. A subset of 60 participants will undergo magnetic resonance imaging within 72 hours and at 4 weeks after recruitment to identify the neurophysiological mechanisms underlying the potential benefits from MBI training in adolescents following a concussion.
RESULTS: The recruitment began in October 2022, and the data collection is expected to be completed by September 2024. Data collection and management is still in progress; therefore, data analysis is yet to be conducted.
CONCLUSIONS: This trial will confirm the feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youth at risk of experiencing prolonged postconcussion symptoms and complications.
BACKGROUND: ClinicalTrials.gov NCT05105802; https://classic.clinicaltrials.gov/ct2/show/NCT05105802.
UNASSIGNED: DERR1-10.2196/57226.
摘要：
背景：儿童和青少年脑震荡是一个重要的公共卫生问题，30%到35%的患者有长期情绪风险，认知，睡眠,或身体症状。这些症状对儿童的生活质量产生负面影响，同时干扰他们参与重要的神经发育活动，如学业，社会化,和体育。脑震荡后的早期心理干预可能会提高调节情绪和适应伤后症状的能力。导致对变化的更大接受度；减少压力；和身体恢复，情感,和认知症状。
目的：本研究的主要目的是评估进行平行组（1：1）随机对照试验（RCT）的可行性，以评估12至<18岁青少年的数字治疗（DTx）正念干预（MBI）。注意力匹配的比较器干预（以前的RCT中也使用的数学游戏）将在同一DTx平台上交付。两组都将获得标准的护理指南。次要目标是检查生活质量的干预趋势;韧性;自我效能感;认知，如注意力，工作记忆,和执行功能；症状负担；以及脑震荡后4周的焦虑和抑郁评分，这将提供更明确的RCT。子样本将用于检查随机分配到实验干预组的那些与随机分配到对照组的那些相比是否具有不同的基于脑的成像模式。
方法：本研究是加拿大卫生部规范的一项双盲试验。共有70名参与者将在脑震荡后7天内注册，并随机分配接受为期4周的DTxMBI（实验组）或比较干预。可行性将根据招聘率进行评估，两种干预措施的治疗依从性，和保留。所有结果指标将在干预前（受伤后7天内）以及受伤后1、2和4周进行评估。60名参与者的子集将在招募后的72小时内和4周内进行磁共振成像，以确定脑震荡后青少年MBI训练潜在益处的神经生理机制。
结果：招聘于2022年10月开始，数据收集预计将于2024年9月完成。数据收集和管理仍在进行中；因此，数据分析尚未进行。
结论：该试验将确认可行性并解决不确定性，以告知未来确定的多中心疗效RCT。如果证明有效,对于有长期脑震荡后症状和并发症风险的青少年,基于智能手机的MBI有可能成为一种可获得且低风险的预防性治疗.
背景：ClinicalTrials.govNCT05105802;https://classic.clinicaltrials.gov/ct2/show/NCT05105802.
■DERR1-10.2196/57226。
目的：本研究的主要目的是评估进行平行组（1：1）随机对照试验（RCT）的可行性，以评估12至<18岁青少年的数字治疗（DTx）正念干预（MBI）。注意力匹配的比较器干预（以前的RCT中也使用的数学游戏）将在同一DTx平台上交付。两组都将获得标准的护理指南。次要目标是检查生活质量的干预趋势;韧性;自我效能感;认知，如注意力，工作记忆,和执行功能；症状负担；以及脑震荡后4周的焦虑和抑郁评分，这将提供更明确的RCT。子样本将用于检查随机分配到实验干预组的那些与随机分配到对照组的那些相比是否具有不同的基于脑的成像模式。
方法：本研究是加拿大卫生部规范的一项双盲试验。共有70名参与者将在脑震荡后7天内注册，并随机分配接受为期4周的DTxMBI（实验组）或比较干预。可行性将根据招聘率进行评估，两种干预措施的治疗依从性，和保留。所有结果指标将在干预前（受伤后7天内）以及受伤后1、2和4周进行评估。60名参与者的子集将在招募后的72小时内和4周内进行磁共振成像，以确定脑震荡后青少年MBI训练潜在益处的神经生理机制。
结果：招聘于2022年10月开始，数据收集预计将于2024年9月完成。数据收集和管理仍在进行中；因此，数据分析尚未进行。
结论：该试验将确认可行性并解决不确定性，以告知未来确定的多中心疗效RCT。如果证明有效,对于有长期脑震荡后症状和并发症风险的青少年,基于智能手机的MBI有可能成为一种可获得且低风险的预防性治疗.
背景：ClinicalTrials.govNCT05105802;https://classic.clinicaltrials.gov/ct2/show/NCT05105802.
■DERR1-10.2196/57226。
