This K23 proposal details a comprehensive 5-year training program that will support the candidate?s transition toward an independent clinical research career focused on the development and rigorous testing of mind-body interventions with an emphasis on prevention of transition from acute to chronic symptoms following illness or injury. In this application the candidate proposes a significant and innovative proposal that is directly tied with his proposed training and career development goals. Background: College-age individuals have particularly high rates of concussions (also known as mTBIs) and anxiety. When these co-occur, there is an increased risk for transition to chronic mTBI symptoms, which are costly and challenging to treat. To date, there are no evidence-based interventions focused on preventing chronic mTBI. The Toolkit for Optimal Recovery (TOR) is a brief, live video mind-body program aimed at preventing chronic pain in patients with acute injuries, which is amenable for adaptations for the needs of college-age individuals with mTBI and anxiety.
Specific aims and research design: The proposed study aims to 1) identify treatment needs and preferences among college-age individuals with acute mTBI and anxiety via live video qualitative interviews (N = 20) to inform adaptation of the TOR and study procedures; 2) explore, via an open pilot (N=5) with exit interviews and pre- and post- self-report assessments, initial feasibility, acceptability, and credibility of the live video TOR-Concussions (TOR-C) and study procedures, and to further refine the intervention, as needed; and 3) establish, via a pilot feasibility RCT of the TOR-C versus a matched dose, time and attention control (N = 50 enrolled), the feasibility, acceptability and credibility of both programs following pre- determined benchmarks. Findings will inform an efficacy trial through the UG3/UH3 o mechanisms, as well as future studies aimed at generalizing this work to other patient populations. Training and mentoring:
Study aims are supported by 3 main training goals aimed at developing expertise in: 1) qualitative methods for mind- body intervention adaptation; 2) mHealth and technology-based approaches, and 3) conduct of rigorous clinical trials, and advanced statistics for clinical trials. These training goals are supported by 1) a team of expert mentors (Vranceanu & Yeh), collaborators (Giacino, Iverson & Macklin), and contributors (Silverberg) that will oversee the progress of the project, 2) a rich institutional environment, and 3) targeted coursework, scientific meetings, seminars and planned publications. Relevance to the NCCIH mission. This K23 proposal is in line with NCCIH?s funding priorities to develop feasible and acceptable mind-body interventions for difficult problems focused on prevention. Impact: Collectively, the experience gained during this award will serve as the foundation for the applicant?s independent career in mind-body preventative interventions, and will start a line of research focused on the development and testing of brief, feasible and scalable mind-body interventions with a focus on prevention of chronic illness.
The proposed study will establish the feasibility, acceptability and credibility of a novel, live video mind-body program, ?Toolkit for Optimal Recovery after Concussions; TOR-C?, aimed at preventing persistent symptoms following uncomplicated mild traumatic brain injury (aka mTBI) among college-age individuals with anxiety. This age group experiences among the highest prevalence of concussions, and up to 40% of these individuals have comorbid anxiety. A brief, tailored mind body program delivered to this high risk population during the window of opportunity of the acute phase has the potential to decrease conversion to costly and challenging-to-treat chronic symptoms of mTBI.
