Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial
BackgroundConcussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child’s quality of life while interfering with thei...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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JMIR Publications
2024-04-01
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| Series: | JMIR Research Protocols |
| Online Access: | https://www.researchprotocols.org/2024/1/e57226 |
| _version_ | 1797214309821972480 |
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| author | Andrée-Anne Ledoux Roger Zemek Molly Cairncross Noah Silverberg Veronik Sicard Nicholas Barrowman Gary Goldfield Clare Gray Ashley D Harris Natalia Jaworska Nick Reed Bechara J Saab Andra Smith Lisa Walker |
| author_facet | Andrée-Anne Ledoux Roger Zemek Molly Cairncross Noah Silverberg Veronik Sicard Nicholas Barrowman Gary Goldfield Clare Gray Ashley D Harris Natalia Jaworska Nick Reed Bechara J Saab Andra Smith Lisa Walker |
| author_sort | Andrée-Anne Ledoux |
| collection | DOAJ |
| description |
BackgroundConcussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child’s quality of life while interfering with their participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt to postinjury symptoms, resulting in the greater acceptance of change; reduced stress; and recovery of somatic, emotional, and cognitive symptoms.
ObjectiveThe primary objective of this study is to assess the feasibility of conducting a parallel-group (1:1) randomized controlled trial (RCT) to evaluate a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to <18 years. The attention-matched comparator intervention (a math game also used in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with the standard of care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory, and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks after concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention group have different brain-based imaging patterns compared with those randomized to the control group.
MethodsThis study is a double-blind Health Canada–regulated trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week DTx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days after injury) and at 1, 2, and 4 weeks after the injury. A subset of 60 participants will undergo magnetic resonance imaging within 72 hours and at 4 weeks after recruitment to identify the neurophysiological mechanisms underlying the potential benefits from MBI training in adolescents following a concussion.
ResultsThe recruitment began in October 2022, and the data collection is expected to be completed by September 2024. Data collection and management is still in progress; therefore, data analysis is yet to be conducted.
ConclusionsThis trial will confirm the feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youth at risk of experiencing prolonged postconcussion symptoms and complications.
Trial RegistrationClinicalTrials.gov NCT05105802; https://classic.clinicaltrials.gov/ct2/show/NCT05105802
International Registered Report Identifier (IRRID)DERR1-10.2196/57226 |
| first_indexed | 2024-04-24T11:12:08Z |
| format | Article |
| id | doaj.art-b608c97886f8439c86d7da460ec240d9 |
| institution | Directory Open Access Journal |
| issn | 1929-0748 |
| language | English |
| last_indexed | 2024-04-24T11:12:08Z |
| publishDate | 2024-04-01 |
| publisher | JMIR Publications |
| record_format | Article |
| series | JMIR Research Protocols |
| spelling | doaj.art-b608c97886f8439c86d7da460ec240d92024-04-11T12:45:34ZengJMIR PublicationsJMIR Research Protocols1929-07482024-04-0113e5722610.2196/57226Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled TrialAndrée-Anne Ledouxhttps://orcid.org/0000-0002-3163-0844Roger Zemekhttps://orcid.org/0000-0001-7807-2459Molly Cairncrosshttps://orcid.org/0000-0003-1926-0569Noah Silverberghttps://orcid.org/0000-0001-6378-148XVeronik Sicardhttps://orcid.org/0000-0003-2452-934XNicholas Barrowmanhttps://orcid.org/0000-0002-4704-9595Gary Goldfieldhttps://orcid.org/0000-0001-6216-7824Clare Grayhttps://orcid.org/0009-0007-5463-2379Ashley D Harrishttps://orcid.org/0000-0003-4731-7075Natalia Jaworskahttps://orcid.org/0000-0001-5643-8210Nick Reedhttps://orcid.org/0000-0001-9360-7888Bechara J Saabhttps://orcid.org/0000-0003-1673-129XAndra Smithhttps://orcid.org/0000-0002-1212-2473Lisa Walkerhttps://orcid.org/0000-0001-5865-7257 BackgroundConcussion in children and adolescents is a significant public health concern, with 30% to 35% of patients at risk for prolonged emotional, cognitive, sleep, or physical symptoms. These symptoms negatively impact a child’s quality of life while interfering with their participation in important neurodevelopmental activities such as schoolwork, socializing, and sports. Early psychological intervention following a concussion may improve the ability to regulate emotions and adapt to postinjury symptoms, resulting in the greater acceptance of change; reduced stress; and recovery of somatic, emotional, and cognitive symptoms. ObjectiveThe primary objective of this study is to assess the feasibility of conducting a parallel-group (1:1) randomized controlled trial (RCT) to evaluate a digital therapeutics (DTx) mindfulness-based intervention (MBI) in adolescents aged 12 to <18 years. The attention-matched comparator intervention (a math game also used in previous RCTs) will be delivered on the same DTx platform. Both groups will be provided with the standard of care guidelines. The secondary objective is to examine intervention trends for quality of life; resilience; self-efficacy; cognition such as attention, working memory, and executive functioning; symptom burden; and anxiety and depression scores at 4 weeks after concussion, which will inform a more definitive RCT. A subsample will be used to examine whether those randomized to the experimental intervention group have different brain-based imaging patterns compared with those randomized to the control group. MethodsThis study is a double-blind Health Canada–regulated trial. A total of 70 participants will be enrolled within 7 days of concussion and randomly assigned to receive the 4-week DTx MBI (experimental group) or comparator intervention. Feasibility will be assessed based on the recruitment rate, treatment adherence to both interventions, and retention. All outcome measures will be evaluated before the intervention (within 7 days after injury) and at 1, 2, and 4 weeks after the injury. A subset of 60 participants will undergo magnetic resonance imaging within 72 hours and at 4 weeks after recruitment to identify the neurophysiological mechanisms underlying the potential benefits from MBI training in adolescents following a concussion. ResultsThe recruitment began in October 2022, and the data collection is expected to be completed by September 2024. Data collection and management is still in progress; therefore, data analysis is yet to be conducted. ConclusionsThis trial will confirm the feasibility and resolve uncertainties to inform a future definitive multicenter efficacy RCT. If proven effective, a smartphone-based MBI has the potential to be an accessible and low-risk preventive treatment for youth at risk of experiencing prolonged postconcussion symptoms and complications. Trial RegistrationClinicalTrials.gov NCT05105802; https://classic.clinicaltrials.gov/ct2/show/NCT05105802 International Registered Report Identifier (IRRID)DERR1-10.2196/57226https://www.researchprotocols.org/2024/1/e57226 |
| spellingShingle | Andrée-Anne Ledoux Roger Zemek Molly Cairncross Noah Silverberg Veronik Sicard Nicholas Barrowman Gary Goldfield Clare Gray Ashley D Harris Natalia Jaworska Nick Reed Bechara J Saab Andra Smith Lisa Walker Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial JMIR Research Protocols |
| title | Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial |
| title_full | Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial |
| title_fullStr | Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial |
| title_full_unstemmed | Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial |
| title_short | Smartphone App–Delivered Mindfulness-Based Intervention for Mild Traumatic Brain Injury in Adolescents: Protocol for a Feasibility Randomized Controlled Trial |
| title_sort | smartphone app delivered mindfulness based intervention for mild traumatic brain injury in adolescents protocol for a feasibility randomized controlled trial |
| url | https://www.researchprotocols.org/2024/1/e57226 |
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