Multisite Randomized Clinical Trial: Mindfulness-Based Intervention for Mild Traumatic Brain Injury (MBI-4-mTBI)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 362
- 试验地点
- 5
- 主要终点
- Pediatric Quality of Life Inventory™ version 4.0
研究概览
简要总结
Formal MBIs, such as Mindfulness-Based Stress Reduction (MBSR), have been shown to increase resiliency and teach affect regulation. However, these formal interventions may not be suitable for acutely concussed youth as they are costly, not easily accessible (trained therapists are needed), and require commitment from parents and children for in-person weekly meetings and at-home practice of learned skills for 8 to 16 weeks. Further, MBSR programs may not be readily accessible immediately after a concussion. With the increasing use of mobile phones and tablets in youth, mobile health offers a powerful platform for mental health interventions. Advantages of app-based interventions include constant availability, greater access, tailored content, lower cost, immediate delivery, and increased service capacity and efficiency. Therefore, the anticipated benefit is to show the efficacy of a pragmatic and low-cost intervention and reduce barriers to care through a novel, innovative and accessible MBI treatment program. This will have both a benefit to public health and expand our understanding of the impact of MBIs on pediatric recovery.
详细描述
The proposed study has two groups: (1) experimental group: usual care plus early introduction of the app-based MBI; and (2) control group: usual care plus early introduction sham application, including the cognitive math game called 2048. Usual care in both groups refers to the recommended return to physical and cognitive activity 24-48 hours post-injury. To maintain valid results, participants will be "blinded" to their intervention. (i.e., during the informed consent process, the study will be referred to as the App-based Intervention study with the purpose of evaluating two app-based interventions). Although only one group will receive the MBI intervention, both groups will be receiving usual care instructions, which involves the early return to cognitive and physical activities. Therefore, both groups will be receiving a beneficial intervention with the experimental group receiving the additional MBI that is being assessed. For both groups, Treatment Coaches will be assigned to each participant. Coaches will maintain regular communication with patients. Their role will be to encourage and assist participants throughout the study duration through a standardized question-and-answer protocol. Additionally, to increase adherence to the intervention, participants will complete a motivational interview at 2 weeks. After 4 weeks, all participants will be offered the MBI program for an extra period of 4 weeks. The control group will have the possibility at that time to crossover and start the intervention if desired.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Pragmatic-blinding
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants presenting to five PERC EDs after sustaining a direct or indirect head injury
- •Aged 12 through 17.99 years
- •Diagnosed with a definite or suspected concussion, defined by the American College of Rehabilitation Medicine definition
- •Score ≥6 on the 5P rule
- •Suffered the index injury in the previous 48 hours
- •Proficient in English or French
排除标准
- •Glasgow Coma Scale ≤13
- •Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required, but may be performed if clinically indicated)
- •Neurosurgical operative intervention, intubation or intensive care required
- •Multi-system injuries with treatment requiring hospital admission, operating room or procedural sedation in ED (Note: hospital admission for observation or management of ongoing concussion symptoms is not an exclusion criteria)
- •Severe neurological developmental delay resulting in communication difficulties
- •Intellectual disability/mental retardation, autism spectrum disorder (history of attention deficit hyperactivity disorder, learning disability, or Tourette's syndrome is not an exclusion)
- •Intoxication at the time of ED presentation as per clinician judgment
- •No clear history of trauma as primary events (e.g., seizure, syncope or migraine)
- •Prior psychiatric hospitalization
- •Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression are not exclusionary)
- •Inability to obtain a proper written informed consent/assent (language barrier, absence of parental authority, developmental delay, intoxication, patient too confused to consent, etc.)
- •Legal guardian not present (certain forms need be completed by parents/legal guardians)
- •No internet or mobile/tablet access.
- •Previously enrolled in phase 1 or phase 2 of the feasibility trial or the efficacy trial.
研究组 & 干预措施
Mindfulness Intervention + Usual Care
Experimental group: MBI training will consist of a 4-week custom-made program that includes setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal. Each standardized course will be unlocked as the participant progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days a week, over a period of 4 weeks (with the option to continue for 8 weeks).
干预措施: Mindfulness Based Intervention (MBI) (Behavioral)
Cognitive Sham + Usual care
Usual care recommends that patients refrain from physical and cognitive activities for 24-48 hours after concussion. After the initial rest period, it is recommended to introduce low to moderate levels of physical and cognitive activity at a level that does not result in recurrence or exacerbation of symptoms. Patients must refrain from any activities that increase the risk of re-injury (body contact or risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. This arm is considered as active participant with the sham app (cognitive math game called "2048") delivered via the same app as the MBI, but without the mindfulness content. Participants will be encouraged to engage in the app-based activities for at least 10 minutes daily, with a minimum of 4 days per week, over a period of 4 weeks. Participants will also be asked questions about their stress, emotions, and symptoms.
干预措施: Cognitive Sham (Behavioral)
结局指标
主要结局
Pediatric Quality of Life Inventory™ version 4.0
时间窗: Day of enrolment (ED), Week 4, Week 8
The PedsQL is a reliable and valid measure of quality of life (QoL) in healthy children and adolescents and those with acute and/or chronic health conditions. Parent versions exist for children aged 2 to 18 years (in 4 age groups) and child versions for those aged 5 and over. For this study, only the child's version (ages 8-12 and ages 13-18) will be used. The inventory covers four domains: physical, emotional, social, and school, the sum of which is total QoL. This measure will be used to assess whether early brief MBI can improve total QoL. Higher scores indicate better health related to QoL.
次要结局
- Connor-Davidson Resilience Scale-10 (CD-RISC)(Day 1, Week 4, & Week 8)
- The 18-item PedsQL™ Multidimensional Fatigue Scale (PedsQL-MFS)(Day 1, Week 4, & Week 8)
- Health and Behaviour Inventory (HBI)(Day of enrolment (ED; retrospective (parents) and post-injury (participant)), Week 2, Week 4, & Week 8)
- The General Anxiety Disorder 7-items (GAD-7)(Day of enrolment (ED), Week 4, & Week 8)
- Center for Epidemiologic Studies Short Depression Scale (CES-D-10)(Day of enrollment (ED), Week 4, & Week 8)
- Child and Adolescent Mindfulness Measure (CAMM)(Day 1, Week 4, & Week 8)
- Pediatric Fear Avoidance Behavior After Traumatic Brain Injury (PFAB-TBI)(Week 4 & Week 8)
- Avoidance and Fusion Questionnaire for Youth Short Form (AFQ-Y8)(Day 1, Week 4 & Week 8)
- Perceived Stress Scale (PSS-10)(Day of enrollment (ED), Week 4, & Week 8)
- Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)(Day 1, Week 4, & Week 8)
- Credibility Score (Credibility and Expectancy Questionnaire (CEQ))(Week 1)
- Modified version of the Client Satisfaction Questionnaire (CSQ)(Week 4)
研究者
Andree-Anne Ledoux
Scientist
Children's Hospital of Eastern Ontario