Mindfulness Intervention in Young Adults With a Concussion History
Condition: Concussion, Brain; Concussion Post Syndrome
MeSH terms: Brain Concussion; Post-Concussion Syndrome
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness Exercises and Meditations
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concussion; Mindfulness; Intervention; Perceived Stress