Acceptability, Feasibility, Usability, and Effectiveness of a Mindfulness Intervention in Young Adults With a Concussion History: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Mean Feasibility of Intervention (FIM) Total Score
研究概览
简要总结
Young adults (aged 18-30) with a concussion history (defined as experiencing a concussion within the past five years but not within the past month) will complete a six-week mindfulness intervention. Throughout the intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day using the LoveYourBrain Foundation Meditation Library. Before the intervention, participants will complete a baseline assessment including demographics, concussion history, mental health history, mindfulness history, perceived stress, mindfulness, and concussion symptoms. Throughout the intervention, participants will complete weekly assessments measuring adherence and concussion symptoms. After six weeks, participants will complete a final, follow-up assessment with assessments for adherence, acceptability, feasibility, intervention perceptions, perceived stress, mindfulness, and concussion symptoms.
This study's aim is to determine the acceptability, feasibility, usability, and effectiveness of a mindfulness intervention in young adults with a concussion history. The investigators hypothesize that participants who participate in the mindfulness intervention will report high adherence (complete five days of meditation per week), positive acceptability, positive feasibility, and positive intervention perceptions. Additionally, after completing the intervention, participants will report decreased perceived stress, increased mindfulness, and decreased concussion symptoms compared to before the intervention.
详细描述
This study is a pilot prospective, feasibility intervention clinical trial. As this is a novel, pilot intervention in the proposed population, the study will utilize an uncontrolled study design where all participants will partake in the six-week, longitudinal mindfulness intervention. All participants will be recruited via the University of North Carolina at Chapel Hill and all data will be collected via the single site. Participants will complete baseline measures for concussion symptoms, perceived stress, and mindfulness. For the six-week intervention, participants will complete 10-20 minutes of mindfulness-focused exercises and meditations each day. Mindfulness exercises will be completed independently using the LoveYourBrain Foundation Meditation Library, a free, online resource containing traumatic brain injury-focused mindfulness-focused exercises and meditations. Mindfulness-based exercises and meditations to be completed will be chosen by study personnel based on tools utilized in mindfulness-based stress reduction programs that are provided on the LoveYourBrain Meditation Library. Specific mindfulness-based exercises and meditations will include body scan, acceptance, awareness, and breathing. At intervention enrollment participants will be presented with a detailed manual providing them with beginner mindfulness tips and instructions as well as details on the purpose for the intervention. Before beginning the exercises and after being presented the manual, participants will be asked by study personnel if they have any questions or concerns regarding the intervention. Throughout the six-week intervention, study personnel will prompt participants via email and text at the beginning of each week with the specific exercises/meditations to be completed each day for that week. Participants will be prompted via email and text at the end of each week to complete a questionnaire to assess adherence and track concussion symptoms. Participants will have one day to complete the weekly assessment. If it is not completed on that day, study personnel will prompt the participant via email and text for three days. If the assessment is not completed in three days, study personnel will call participants to complete the assessment. At three weeks (halfway through the intervention), study personnel will call participants to complete the weekly assessment and check in on participation. Upon completion of the six-week trial, participants will be prompted via email and text to complete a final assessment including questions regarding adherence, acceptability, feasibility, intervention perceptions, concussion symptoms, perceived stress, and mindfulness. Participants will have one day to complete the final assessment. If they have not completed the final assessment at that time, study personnel will prompt the participant via email and text for three days. If it is not completed after three days, study personnel will call the participant to complete the assessment over the phone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This pilot study has no masking.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Young adults aged 18-30
- •Concussion history (defined as experiencing a concussive injury within the past five years, but not within the past month)
排除标准
- •History of moderate and/or severe traumatic brain injury
- •Currently under provider care for a concussion/traumatic brain injury
- •Health risks (heart conditions, respiratory disorders, and/or neurological disorders) that put them at greater than minimal risk
- •Current mindfulness practice
- •There will be no exclusion based on self-report sex, race, ethnicity, or mental health history.
结局指标
主要结局
Mean Feasibility of Intervention (FIM) Total Score
时间窗: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Feasibility will be measured during the post-intervention follow-up (week 6) assessment using the FIM, a four-item validated measure assessing intervention feasibility. The FIM is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive feasibility). The outcome for feasibility will be the FIM total score (range=4-20). The mean FIM total score for all participants will be reported.
Mean Acceptability of Intervention (AIM) Total Score
时间窗: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Acceptability will be assessed during the post-intervention follow-up (week 6) assessment using the AIM. The AIM is a four-item validated measure assessing associations with an intervention. It is assessed on a five-point scale from 1=completely disagree to 5=completely agree. A total score will be computed by summing the responses for all four items (higher scores indicating more positive acceptance). The outcome for acceptability will be the AIM total score (range=4-20). The mean AIM total score for all participants will be reported.
次要结局
- Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score(Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.)
- Mean Days of Mindfulness Exercises/Meditations Completed Per Week(Approximately 7 to 42 days after intervention initiation.)
- Mean Perceived Stress Scale (PSS-10) Total Score(Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.)
- Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score(Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.)