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Principal Investigator: Jonathan Greenberg
Organization: MASSACHUSETTS GENERAL HOSPITAL
Fiscal Year: 2024
Award: $157,939
Funding agency: National Center for Complementary and Integrative Health
Project Summary
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.
Terms: <Access to Care><Acute><Adherence><After Care><After-Treatment><Aftercare><Age><Anxiety><Attention><Award><Behavioral><Benchmarking><Best Practice Analysis><Brain Concussion><Cephalalgia><Cephalgia><Cephalodynia><Cerebral Concussion><Chronic><Chronic Disease><Chronic Illness><Clinical><Clinical Research><Clinical Study><Clinical Trials><Cognitive><Commotio Cerebri><Complex><Cranial Pain><Data Collection><Development><Dizziness><Dose><Educational process of instructing><Eligibility><Eligibility Determination><Emotional><Enrollment><Environment><Evidence based intervention><Evidence based treatment><Fear><Foundations><Fright><Funding><Future><Goals><Head Pain><Headache><Health><Health Services Accessibility><High Prevalence><Home><Individual><Injury><Insomnia><Insomnia Disorder><Institution><Intervention><Intervention Strategies><Interview><Investigators><K23 Award><K23 Mechanism><K23 Program><Link><MTBI><Medical><Memory Deficit><Memory impairment><Mental Health Services><Mental Hygiene Services><Mentored Patient-Oriented Research Career Development Award><Mentored Patient-Oriented Research Career Development Award (K23)><Mentors><Methods><Mild Concussions><Mind-Body Intervention><Mind-Body Medicine><Mission><Modeling><Musculoskeletal Pain><NCCAM><NCCIH><National Center for Complementary and Integrative Health><National Center for Complementary and Integrative Medicine><Neurologic><Neurological><Orthopedic><Orthopedic Surgical Profession><Orthopedics><Patient Self-Report><Patients><Persons><Phase><Placebo Control><Population><Post-Concussion Symptoms><Post-Concussion Syndrome><Post-Concussive Symptoms><Post-Concussive Syndrome><Preventative intervention><Prevention><Procedures><Process><Protocol Screening><Publications><Qualitative Methods><Qualitative Research><Recovery><Relaxation><Reporting><Research><Research Design><Research Personnel><Researchers><Risk><Scientific Publication><Self-Report><Sleeplessness><Specific qualifier value><Specified><Study Type><Symptoms><Teaching><Technology><Testing><Time><Training><Training Programs><Work><acceptability and feasibility><access to health services><access to services><access to treatment><accessibility to health services><adult youth><age group><ages><anxiety symptoms><anxious symptom><attentional control><availability of services><benchmark><brain-body interaction><care access><career><career development><chronic disorder><chronic pain><chronic symptom><co-morbid><co-morbidity><college><college student><collegiate><comorbidity><concussion><concussion symptom><concussive><concussive symptom><cost><develop therapy><developmental><disability><efficacy trial><enroll><experience><head ache><health service access><health services availability><high risk group><high risk individual><high risk people><high risk population><homes><improved><injuries><injury recovery><innovate><innovation><innovative><intervention development><intervention for prevention><intervention refinement><interventional strategy><m-Health><mHealth><meeting><meetings><memory dysfunction><mental health care><mental healthcare><mild TBI><mild brain trauma><mild traumatic brain injury><mind body approach><mind body interaction><mind body medicine skills><mind body techniques><mind body therapy><mind body treatments><mind body wellness><mind/body><mobile health><multidisciplinary><neural imaging><neuro-imaging><neuroimaging><neurological imaging><novel><parenting education intervention><parenting education programs><parenting intervention><parenting program><parenting skill training><parenting training><patient population><persistent symptom><physical symptom><placebo controlled><post treatment><preference><prevent><preventing><prevention intervention><preventional intervention strategy><preventive intervention><prognostic ability><prognostic power><prognostic utility><prognostic value><programs><psychologic><psychological><qualitative reasoning><recovery after injury><recovery following injury><recovery post injury><recruit><response><satisfaction><screening><screenings><service availability><skills><social stigma><statistics><stigma><study design><therapy development><treatment access><treatment development><university student><young adult><young adulthood>