symptom-targeted approach to rehabilitation for concussion (star-c)

Conditions: Mild Traumatic Brain Injury (mTBI)

Summary: purpose: investigators propose a three-arm rct across two military treatment facilities:1) in-person star-c, 2) telehealth star-c, and 3) no treatment control. outcomes will be assessed immediately and at one- and three-months post treatment. hypothesis/objectives: star-c, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mtbi. effectiveness will be moderated by patient characteristics. stakeholder feedback will yield a process map for broad implementation of star-c in varied clinical environments.

specific aim 1 (primary for rct): to evaluate effectiveness of star-c. hypothesis 1a: in-person star-c will lead to a greater decrease in everyday cognitive complaints (c4) compared to wait-list control. hypothesis 1b: tele star-c will lead to a greater decrease in everyday cognitive complaints (c4) compared to wait-list control. specific aim 2 (secondary): to evaluate maintenance of treatment effects using a practice based evidence approach. question 2a: what proportion of in-person star-c treatment effects (c4 and gas) will be maintained at the 3-month follow-up? question 2b: what proportion of telehealth star-c treatment effects (c4 and gas) will be maintained at the 3-month follow-up? specific aim 3 (exploratory): to explore factors associated with heterogeneity in treatment response. question 3a: what factors prevented participants from achieving a ≥2-point improvement on the c4? question 3b: what factors prevented participants from maintaining ≥2-point improvement on the c4? question 3c: what factors prevented participants from achieving ≥2 out of 3 targets using gas? question 3d: what factors contributed to participants maintaining or exceeding targets (gas) at the 3-month follow-up? specific aim 4 (implementation): use stakeholder input (to include clinicians, administrators, and patients) from capacity assessment and after-action review to generate an implementation package for clinics interested in star-c. question 4: for what proportion of patients will clinicians rate star-c as acceptable, appropriate, and feasible (aim/iam/fim)?

Eligibility criteria:
inclusion criteria: * mtbi defined per the va/dod clinical practice guideline for the management of concussion-mild traumatic brain injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously. * a score of 2, 3, or 4 on any of the four cognitive items on the nsi, to include participants who have cognitive complaints. * a score on the word reading subtest of the wide range achievement test of a sixth-grade reading level or higher, to ensure participants can read study materials. exclusion criteria: * history of a moderate, severe, or penetrating tbi as defined by dod/va guidelines. * lifetime diagnosis of schizophrenia or other psychotic/thought disorder. * current participation in intensive behavioral health treatment (≥3 appointments /encounters per week) for any psychiatric or substance use disorder. * current participation in other treatments that target cognition (e.g., computer based cognitive rehabilitation). * history of a neurological disease affecting cognitive function, other than mild tbi, such as multiple sclerosis, stroke, brain tumor, or parkinson disease. * current, active suicidal or homicidal ideation. * daily use of narcotic pain medications. * lack of access to technology or internet/cell phone service that supports telemedicine. * current participation in other therapy targeting cognition (note: this is not the same as cognitive behavioral therapy/cbt which addresses psychological issues and may continue during participation in this research project).

Keywords: concussion brain injury cognitive rehabilitation military adults