Clinical trial NCT05399849: Mindfulness Intervention in Young Adults With a Concussion History
Official title: Acceptability, Feasibility, Usability, and Effectiveness of a Mindfulness Intervention in Young Adults With a Concussion History: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Concussion Post Syndrome
Keywords: Concussion
Mindfulness
Intervention
Perceived Stress
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Young adults aged 18-30
* Concussion history (defined as experiencing a concussive injury within the past five years, but not within the past month)

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Acceptability of Intervention (AIM) Total Score
timeFrame: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
measure: Mean Feasibility of Intervention (FIM) Total Score
timeFrame: Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Secondary outcomes:
measure: Mean Days of Mindfulness Exercises/Meditations Completed Per Week
timeFrame: Approximately 7 to 42 days after intervention initiation.
measure: Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score
timeFrame: Baseline (pre-intervention, week 0).
measure: Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score
timeFrame: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
measure: Mean Perceived Stress Scale (PSS-10) Total Score
timeFrame: Baseline (pre-intervention, week 0).
measure: Mean Perceived Stress Scale (PSS-10) Total Score
timeFrame: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
measure: Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
timeFrame: Baseline (pre-intervention, week 0).
measure: Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score
timeFrame: Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Christine E Callahan, MS
role: PRINCIPAL_INVESTIGATOR
References: