Mindfulness-Based Intervention for Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Adherence to Treatment
研究概览
简要总结
Mindfulness is a promising tool which may foster adaptative interpersonal qualities to reduce the risk of persistent post-concussion symptoms. The present feasibility study will customize and validate a mindfulness mobile smart-phone app easily accessible to youth and families. The study will also determine whether mindfulness training increases quality of life, reduces symptom burden and promotes neurophysiological recovery at 4 weeks post-injury in adolescents who were diagnosed with an acute concussion compared to a cognitive sham app + usual care.
详细描述
One in three youth with a concussion will be afflicted with persistent post-concussive symptoms (PPCS), defined as the persistence of symptoms beyond one month of injury. PPCS may impair daily activities including schoolwork, socializing, and sports, thus reducing the quality of life. Preventive psychological interventions that foster coping skills may be key to managing concussions and reducing the risk of PPCS. Mindfulness-Based Interventions (MBI) are "present-centered" interventions, encouraging acceptance of thoughts and emotions as they occur in the moment, without judgment. The goal of the present pilot and feasibility randomized clinical trial (RCT) is to investigate whether the introduction of early targeted MBI training, delivered via a mobile application, can increase the quality of life and lead to improved adaptation to acute impairments of concussion. Further, we will establish the feasibility of conducting a larger RCT by investigating the ease of recruitment, credibility score, adherence to treatment, and retention of an app-based MBI. Participants with an acute concussion will be randomly assigned to one of two groups: (1) experimental group (n=63): early introduction of the MBI training; (2) control group (n=63): sham cognitive task and usual care. The targeted MBI training consists of a 4-week custom-made program for youth. Each standardized psychoeducation of meditation practice will be unlocked as the participant progresses through the program. The curriculum is based on previous validated MBI app protocols and team expertise in MBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind study
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
- •Subjects presenting to CHEO's Emergency Department (ED) within 48 hours of sustaining a direct or indirect head injury
- •Aged 12 through 17.99 years
- •Have a concussion, as defined by the Berlin consensus statement
- •Score >4 on the predicting persistent postconcussive problems in pediatric (5P) clinical rule
- •Proficient in English.
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 chronic neurological developmental delay resulting in communication difficulties
- •Intoxication at the time of ED presentation as per clinician judgment
- •History of trauma as primary events (e.g., seizure, syncope, migraine)
- •Prior psychiatric hospitalization
- •Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression is not exclusionary)
- •Inability to obtain a proper written informed consent/assent (e.g., language barrier, absence of parental authority, developmental delay, intoxication, patients too confused to consent)
- •Legal guardian not present (certain forms need to be completed by parents/legal guardians)
- •No Internet or mobile/tablet access.
结局指标
主要结局
Adherence to Treatment
时间窗: 4 weeks post-injury
Calculated based on the time spent on the app. A higher score means better adherence.
Ease of Recruitment
时间窗: 48 hours post-injury
Descriptive variable. Ease of recruitment will be defined as having at least 60% approached and eligible participants agreeing to participate. A higher score means easier recruitment.
Credibility Score (Credibility and Expectancy Questionnaire)
时间窗: 1 week post-injury
The Credibility and Expectancy Questionnaire is a 6-item The credibility score is derived from the items 1-3 and the expectancy scores is derived from the items 4-6. A higher score means better credibility. The treatment will be considered as credible if 80% of the participants rated the treatment as credible.
Retention
时间窗: 4 weeks post-injury
Descriptive variable. Adequate retention will be defined as having 70% of participants completing at least 60% of the 4-week intervention and the outcome measurement post-treatment. A higher score means better retention.
次要结局
- Child and Adolescent Mindfulness Measure(4 weeks post-injury)
- Post-Concussion Symptom Inventory (PCSI)(2 and 4 weeks post-injury)
- Self-Efficacy Questionnaire for Children(4 weeks post-injury)
- NIH Toolbox Cognitive Battery(4 weeks post-injury)
- Functional Connectivity measured by Resting-State Functional MRI(72 hours and 4th week post-injury)
- Pediatric Quality of Life Inventory™ version 4.0(4 weeks post-injury)
- Health and Behaviour Inventory(2 and 4 weeks post-injury)
- General Anxiety Disorder 7-items (GAD)(4 weeks post-injury)
- Center for Epidemiologic Studies Short Depression Scale(4 weeks post-injury)
- The Connor-Davidson Resilience Scale-10(4 weeks post-injury)
研究者
Andree-Anne Ledoux
Scientist
Children's Hospital of Eastern Ontario