A Decentralized, Investigator Blinded, Randomized, Parallel-group Study to Determine the Feasibility of an 8-week Smart-phone App Delivered Mindfulness- Based Intervention Versus a Health Education Program for Adolescents With Persisting Symptoms After Concussion/mTBI
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
Concussion or mild traumatic brain injury (mTBI) is a major public health concern. Most adolescents will recover from mTBI without complication; however, a sizeable minority experience symptoms that last more than one most post-injury (i.e., persisting symptoms after concussion). Few evidence-based treatments exist for adolescents with persisting symptoms after concussion. Mindfulness-based interventions (MBIs) are effective for treating a wide range of mental and physical health conditions that overlap with post-concussion symptoms. Participants will participate in an 8-week smartphone app-based MBI or a health education program as a control. The study will determine the practicality of doing a larger study to evaluate the effectiveness of the MBI by assessing participants' level of interest, view of intervention helpfulness, and their completion of all the components of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Structured interview confirming a concussion/mTBI or suspected concussion/mTBI diagnosis according to the American Congress of Rehabilitation Medicine definition
- •Concussion/mTBI occurred 1-12 months prior to randomization
- •Persisting symptoms after concussion as demonstrated by a score >75th percentile on the Health and Behaviour Inventory compared to orthopedic injury normative group
- •English proficiency
排除标准
- •Parent- or self-reported psychiatric hospitalization in past year or prior diagnosis of a psychiatric disorders or psychiatric symptoms that may be contraindicated for mindfulness-based interventions (e.g., psychosis)
- •Participation in a clinical trial using the Dawn intervention app in acute concussion (e.g., <2 weeks post-injury).
研究组 & 干预措施
Mindfulness-based intervention
干预措施: Mindfulness-based intervention (Behavioral)
Health education
干预措施: Health Education (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: at randomization
% eligible participants randomized
Eligibility
时间窗: pre-enrollment
% screened that are eligible
Treatment Adherence
时间窗: post-intervention questionnaires (Week 8)
% participants who complete 70% of the intervention
Retention
时间窗: post-intervention questionnaires (Week 8)
% participants who complete follow-up assessment
次要结局
- Treatment credibility and expectancy(7-14 days post-enrollment)
- Treatment Satisfaction(Post-intervention questionnaires (Week 8))
研究者
Molly Cairncross
Assistant Professor
Simon Fraser University