Mindfulness Intervention in Young Adults With a Concussion History

Acceptability, Feasibility, Usability, and Effectiveness of a Mindfulness Intervention in Young Adults With a Concussion History: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Concussion Post Syndrome; Concussion, Brain
• Intervention / Treatment: Behavioral: Mindfulness Exercises and Meditations

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-8700
      • The University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness Intervention; All participants will be enrolled in the mindfulness intervention arm to complete the six-week mindfulness intervention.

Behavioral: Mindfulness Exercises and Meditations; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Acceptability of Intervention (AIM) Total Score	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.	Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.
Mean Feasibility of Intervention (FIM) Total Score	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.	Follow-up (post-intervention, week 6) approximately 42 days after intervention initiation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Days of Mindfulness Exercises/Meditations Completed Per Week	Throughout the intervention participants will be prompted to complete a weekly questionnaire to assess adherence. Subjects will be asked which mindfulness exercises/meditations they completed for that week. Adherence will be assessed at weeks 1, 2, 3, 4, 5, and 6 (post-intervention follow-up). The outcome for adherence will be the number of days of mindfulness exercises/meditations completed per week (range=0-7). The mean number of days of mindfulness exercises/meditations completed per week for all participants will be reported.	Approximately 7 to 42 days after intervention initiation.
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score	Concussion symptoms will be measured using the RPQ, a validated measure which asks participants to report the presence and severity (0-4) of 18 concussion-related symptoms compared with before their concussion. The RPQ has been frequently used in the study population. Concussion symptoms will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). Outcomes for concussion symptoms will include the total symptoms (range=0-18) and total symptom severity (range=0-72) reported from the RPQ. The mean RPQ total symptoms and total symptom severity for all participants will be reported.	Baseline (pre-intervention, week 0).
Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score	Concussion symptoms will be measured using the RPQ, a validated measure which asks participants to report the presence and severity (0-4) of 18 concussion-related symptoms compared with before their concussion. The RPQ has been frequently used in the study population. Concussion symptoms will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). Outcomes for concussion symptoms will include the total symptoms (range=0-18) and total symptom severity (range=0-72) reported from the RPQ. The mean RPQ total symptoms and total symptom severity for all participants will be reported.	Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Mean Perceived Stress Scale (PSS-10) Total Score	Perceived stress will be measured using the PSS-10, the most widely used psychological instrument for measuring perceived stress. The PSS-10 is well validated and had been used in connection to mindfulness and in brain injury populations. The PSS-10 consists of 10 questions on a five-point scale (0=never to 4=very often) about how often a participant has felt or thought a certain way relative to their perceived stress in the past month. Final scores will be obtained by reversing responses to the four positively stated items and then summing all 10 scale items (higher scores indicate higher perceived stress). Perceived stress will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for perceived stress will be the PSS-10 total score (range=0-40). The mean PSS-10 total score for all participants will be reported.	Baseline (pre-intervention, week 0).
Mean Perceived Stress Scale (PSS-10) Total Score	Perceived stress will be measured using the PSS-10, the most widely used psychological instrument for measuring perceived stress. The PSS-10 is well validated and had been used in connection to mindfulness and in brain injury populations. The PSS-10 consists of 10 questions on a five-point scale (0=never to 4=very often) about how often a participant has felt or thought a certain way relative to their perceived stress in the past month. Final scores will be obtained by reversing responses to the four positively stated items and then summing all 10 scale items (higher scores indicate higher perceived stress). Perceived stress will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for perceived stress will be the PSS-10 total score (range=0-40). The mean PSS-10 total score for all participants will be reported.	Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score	Mindfulness will be measured using the FFMQ. This widely used, valid survey to measure mindfulness has been researched extensively connected to perceived stress. Participants will be asked 39 questions on a five-point scale (1=never/very rarely true to 5=very often/always true) related to general mindfulness tendencies in daily life. Final scores will be obtained by reversing responses to the 19 reverse scored questions and then summing all 39 items (higher scores indicate greater mindfulness levels). Mindfulness will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for mindfulness will be the FFMQ total score (range=39-195). The mean FFMQ total score for all participants will be reported.	Baseline (pre-intervention, week 0).
Mean Five Facet Mindfulness Questionnaire (FFMQ) Total Score	Mindfulness will be measured using the FFMQ. This widely used, valid survey to measure mindfulness has been researched extensively connected to perceived stress. Participants will be asked 39 questions on a five-point scale (1=never/very rarely true to 5=very often/always true) related to general mindfulness tendencies in daily life. Final scores will be obtained by reversing responses to the 19 reverse scored questions and then summing all 39 items (higher scores indicate greater mindfulness levels). Mindfulness will be assessed at baseline (pre-intervention, week 0) and follow-up (post-intervention, week 6). The outcome for mindfulness will be the FFMQ total score (range=39-195). The mean FFMQ total score for all participants will be reported.	Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Christine E Callahan, MS, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): October 2, 2022
• Study Completion (Actual): October 2, 2022

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Concussion; Mindfulness; Intervention; Perceived Stress
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 22-0732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: Beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Approval from an IRB, IEC or REB and an executed data use/sharing agreement with the UNC-Chapel Hill.
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No