Mindfulness Intervention in Young Adults With a Concussion History

NCT05399849 | Completed

• 1 other identifier: 22-0732
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain; Concussion Post Syndrome

Keywords

Concussion; Mindfulness; Intervention; Perceived Stress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Mean Days of Mindfulness Exercises/Meditations Completed Per Week

  Approximately 7 to 42 days after intervention initiation.

• Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score

  Baseline (pre-intervention, week 0).

• Mean Rivermead Post-Concussion Questionnaire (RPQ) Symptom and Severity Score

  Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.

• Mean Perceived Stress Scale (PSS-10) Total Score

  Baseline (pre-intervention, week 0).

• Mean Perceived Stress Scale (PSS-10) Total Score

  Follow-up (post-intervention, week 6). Approximately 42 days after intervention initiation.

Study Arms (1)

Mindfulness Intervention

EXPERIMENTAL

All participants will be enrolled in the mindfulness intervention arm to complete the six-week mindfulness intervention.

Behavioral: Mindfulness Exercises and Meditations

Interventions

Mindfulness Exercises and Meditations BEHAVIORAL

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.

Mindfulness Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-8700, United States

Location

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome

Interventions

Meditation

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christine E Callahan, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This pilot study has no masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: July 25, 2022
• Primary Completion: October 2, 2022
• Study Completion: October 2, 2022
• Last Updated: October 14, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 and continuing for 36 months following publication
• Access Criteria: Approval from an IRB, IEC or REB and an executed data use/sharing agreement with the UNC-Chapel Hill.

Locations

US (1)