Mindfulness-Based Intervention for Mild Traumatic Brain Injury

NCT05105802 | Completed DMC

• 1 other identifier: 20190441
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness is a promising tool which may foster adaptative interpersonal qualities to reduce the risk of persistent post-concussion symptoms. The present feasibility study will customize and validate a mindfulness mobile smart-phone app easily accessible to youth and families. The study will also determine whether mindfulness training increases quality of life, reduces symptom burden and promotes neurophysiological recovery at 4 weeks post-injury in adolescents who were diagnosed with an acute concussion compared to a cognitive sham app + usual care.

Conditions

Concussion, Mild

Keywords

mild traumatic brain injury; intervention; treatment; persistent post-concussive symptoms; quality of life; meditation

Outcome Measures

Primary Outcomes (4)

• Ease of Recruitment

  Descriptive variable. Ease of recruitment will be defined as having at least 60% approached and eligible participants agreeing to participate. A higher score means easier recruitment.

  48 hours post-injury

• Credibility Score (Credibility and Expectancy Questionnaire)

  The Credibility and Expectancy Questionnaire is a 6-item The credibility score is derived from the items 1-3 and the expectancy scores is derived from the items 4-6. A higher score means better credibility. The treatment will be considered as credible if 80% of the participants rated the treatment as credible.

  1 week post-injury

• Retention

  Descriptive variable. Adequate retention will be defined as having 70% of participants completing at least 60% of the 4-week intervention and the outcome measurement post-treatment. A higher score means better retention.

  4 weeks post-injury

• Adherence to Treatment

  Calculated based on the time spent on the app. A higher score means better adherence.

  4 weeks post-injury

Secondary Outcomes (10)

• Pediatric Quality of Life Inventory™ version 4.0

  4 weeks post-injury

• Health and Behaviour Inventory

  2 and 4 weeks post-injury

• Post-Concussion Symptom Inventory (PCSI)

  2 and 4 weeks post-injury

• Self-Efficacy Questionnaire for Children

  4 weeks post-injury

• NIH Toolbox Cognitive Battery

  4 weeks post-injury

Study Arms (2)

Mindfulness Intervention

EXPERIMENTAL

MBI training will consist of a 4-week custom-made program that include, setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal. Each standardized course will be unlocked as the child progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days in a week, over a period of 4 weeks.

Behavioral: Mindfulness-Based Intervention

Cognitive Sham Application + Usual Care

ACTIVE COMPARATOR

Usual care recommends that the patient refrain from physical and cognitive activities for 24-48 hours after injury. After the rest period, it is recommended that low to moderate levels of physical and cognitive activity be gradually started 24-48 hours after injury. The activities should be performed at a level that does not result in recurrence or exacerbation of symptoms. Children must refrain from any activities that increase the risk of re-injury (drills with body contact or that risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. We consider this arm as active as participants will be assigned to a cognitive sham app (cognitive math game) delivered via the same app (same main interface as the mindfulness intervention). However, they will not take part in the MBI program for the first 4 weeks. On a daily basis, participants will be asked questions about their stress and emotions and about their symptoms.

Behavioral: Cognitive Sham + Usual Care

Interventions

Mindfulness-Based Intervention BEHAVIORAL

Using AmDtx MBI-based app, targeted MBI training will consist of a 4-week custom-made program that include, setting intentions and check-in with mood, audio-recorded lectures, guided meditations such as body scans, and writing events journal (Appendix 5). Each standardized course will be unlocked as the child progresses through the program. Users will be encouraged to participate in the app-based activities for a total of 10-15 minutes every day, with a minimum of 4 days in a week, over a period of 4 weeks.

Also known as: MBI, AmDtx

Mindfulness Intervention

Cognitive Sham + Usual Care BEHAVIORAL

Usual care recommends that the patient refrain from physical and cognitive activities for 24-48 hours after injury. After the rest period, it is recommended that low to moderate levels of physical and cognitive activity be gradually started 24-48 hours after injury. The activities should be performed at a level that does not result in recurrence or exacerbation of symptoms. Children must refrain from any activities that increase the risk of re-injury (drills with body contact or that risk falls) until fully asymptomatic and cleared by their primary care or other medical provider. The sham journey will consist of playing an open-source cognitive math game delivered through the same app as MBI, but without the mindfulness content.

Also known as: Cognitive Sham, Usual Care

Cognitive Sham Application + Usual Care

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects presenting to CHEO's Emergency Department (ED) within 48 hours of sustaining a direct or indirect head injury
• Aged 12 through 17.99 years
• Have a concussion, as defined by the Berlin consensus statement
• Score \>4 on the predicting persistent postconcussive problems in pediatric (5P) clinical rule
• Proficient in English.

You may not qualify if:

• Glasgow Coma Scale ≤13
• Abnormality on standard neuroimaging studies, including positive head CT findings (Note: neuroimaging is not required but may be performed if clinically indicated)
• Neurosurgical operative intervention, intubation, or intensive care required
• Severe chronic neurological developmental delay resulting in communication difficulties
• Intoxication at the time of ED presentation as per clinician judgment
• History of trauma as primary events (e.g., seizure, syncope, migraine)
• Prior psychiatric hospitalization
• Inability to obtain a proper written informed consent/assent (e.g., language barrier, absence of parental authority, developmental delay, intoxication, patients too confused to consent)
• Legal guardian not present (certain forms need to be completed by parents/legal guardians)
• No Internet or mobile/tablet access.

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead
• Mobio Interactive PTE LTD: collaborator
• University of Ottawa: collaborator
• Academic Health Science Centres: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Canada

Location

Related Publications (1)

• Ledoux AA, Zemek R, Cairncross M, Silverberg N, Sicard V, Barrowman N, Goldfield G, Gray C, Harris AD, Jaworska N, Reed N, Saab BJ, Smith A, Walker L. Smartphone App-Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 11;13:e57226. doi: 10.2196/57226.

  PMID: 38602770 DERIVED

MeSH Terms

Conditions

Brain Concussion

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

Study Officials

• Andrée-Anne Ledoux, PhD

  Children's Hospital of Eastern Ontario Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: Double-blind randomized clinical trial with 2 groups

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 3, 2021
• Study Start: October 4, 2022
• Primary Completion: July 6, 2024
• Study Completion: July 6, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: These documents will be shared once the protocol is published, approximately 6 months from now.
• Access Criteria: The protocol will be accessible online and through Trials.gov.

Locations

CA (1)