Abstract
<h3>Research Objectives</h3> To deliver a feasibility pilot trial to evaluate the acceptability and limited effectiveness of the internet-delivered cognitive behavioural therapy (ICBT) program that has been designed for persons with mild traumatic brain injury (mTBI) to improve overall well-being. <h3>Design</h3> A mixed-methods feasibility trial will be conducted to evaluate ICBT among persons with mTBI. Data will be collected at three time points, baseline, post-treatment and 3-month follow-up. Post-treatment, participants will complete a brief semi-structured interview examining the barriers and facilitators of the program. <h3>Setting</h3> Participants will be recruited from outpatient brain injury and stroke clinics by their health care providers. <h3>Participants</h3> A priori sample size of 20 has been calculated to be sufficient to detect a power of 90% and alpha at .05 with an effect size of 0.8 and accounted for a potential dropout of 30%. Potential participants will undergo an extensive screening process involving interviews to assess suicide risk and cognitive status. <h3>Interventions</h3> The ICBT program consists of six modules, including lessons on psychoeducation on the mTBI symptoms, managing symptoms of depression and anxiety, with a registered mental health professional contacting them once per week for up to 12 weeks, leading to personalized care. <h3>Main Outcome Measures</h3> The primary outcomes for the study include the feasibility and acceptability of the ICBT program. Secondary outcome measures include depression and anxiety. <h3>Results</h3> It is hypothesized that the ICBT program will be acceptable to participants and improve patient-reported outcomes from baseline to follow-up. Additionally, participants will provide valuable information on the strengths and challenges of the ICBT program to further improve and better serve this population's needs. <h3>Conclusions</h3> This research is expected to significantly improve health outcomes and mental health care delivery for individuals with mTBI and for those with other neurological conditions. The results of this study will guide larger studies to evaluate the program's effectiveness in a community setting. <h3>Author(s) Disclosures</h3> No conflict between any of the authors.
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