Mindfulness-Based Intervention for Mild Traumatic Brain Injury

NCT ID: NCT05105802

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-04
• Study Completion Date: 2024-07-06

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.

Detailed Description

One in three youth with a concussion will be afflicted with persistent post-concussive symptoms (PPCS), defined as the persistence of symptoms beyond one month of injury. PPCS may impair daily activities including schoolwork, socializing, and sports, thus reducing the quality of life. Preventive psychological interventions that foster coping skills may be key to managing concussions and reducing the risk of PPCS. Mindfulness-Based Interventions (MBI) are "present-centered" interventions, encouraging acceptance of thoughts and emotions as they occur in the moment, without judgment. The goal of the present pilot and feasibility randomized clinical trial (RCT) is to investigate whether the introduction of early targeted MBI training, delivered via a mobile application, can increase the quality of life and lead to improved adaptation to acute impairments of concussion. Further, we will establish the feasibility of conducting a larger RCT by investigating the ease of recruitment, credibility score, adherence to treatment, and retention of an app-based MBI. Participants with an acute concussion will be randomly assigned to one of two groups: (1) experimental group (n=63): early introduction of the MBI training; (2) control group (n=63): sham cognitive task and usual care. The targeted MBI training consists of a 4-week custom-made program for youth. Each standardized psychoeducation of meditation practice will be unlocked as the participant progresses through the program. The curriculum is based on previous validated MBI app protocols and team expertise in MBI.

Conditions

Concussion, Mild

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Mindfulness Intervention

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.

Group Type: EXPERIMENTAL

Mindfulness-Based Intervention

Intervention Type: 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.

Cognitive Sham Application + Usual Care

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Sham + Usual Care

Intervention Type: 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.

Interventions

Mindfulness-Based Intervention

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.

Intervention Type: BEHAVIORAL

Cognitive Sham + Usual Care

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBI, AmDtx; Cognitive Sham, Usual Care

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Prior diagnosis of severe psychiatric disorder such as schizophrenia (diagnosis of anxiety or depression is not exclusionary)
• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mobio Interactive PTE LTD

INDUSTRY

Sponsor Role: collaborator

University of Ottawa

OTHER

Sponsor Role: collaborator

Academic Health Science Centres

OTHER

Sponsor Role: collaborator

Children's Hospital of Eastern Ontario

OTHER

Sponsor Role: lead

Responsible Party

Andree-Anne Ledoux

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrée-Anne Ledoux, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Eastern Ontario Research Institute

Locations

Children's Hospital of Eastern Ontario

Ottawa, , Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 38602770 (View on PubMed)

Other Identifiers

20190441

Identifier Type: -

Identifier Source: org_study_id