Acute Neurobehavioral Program for Improving Functional Status After TBI

More than 1.4 million people a year in the United States begin confronting life with the
medical, cognitive, and psychosocial challenges resulting from traumatic brain injury (TBI).
A range of cognitive impairments commonly observed following injury increase caregiver
burden as well as per-person lifetime costs for care and support of survivors of TBI,
estimated at $600,000 to $1,875,000. Our long-term goal is to lessen these burdens through
improving the functional status of patients with TBI by providing an evidence-based,
comprehensive, brief, acute-care intervention, First Steps Acute Neurobehavioral and
Cognitive Intervention (FANCI). The 10-sesson, manualized FANCI Program will be tested in a
controlled, randomized study. Therapeutic components of the FANCI include didactics,
cognitive remediation, demonstration, guided self-reflection, rehearsal, and supported
practice of skills and strategies. Specific hypotheses are that 1) FANCI will result in more
improvement in functional status compared to standard interdisciplinary rehabilitation
treatment and 2) FANCI will result in more improvement on measures of neurobehavioral
functioning compared to standard rehabilitation care for patients with moderate to severe
TBI. We base these hypotheses on the observations that 1) providing information about
symptoms, treatment, and coping results in reduced symptom intensity and duration for
patients with TBI, and 2) inpatient participants in recent FANCI pilot studies learned >80%
of the FANCI Program curriculum, and 3) the most recent pilot study participants had
significantly better functional outcomes at discharge than matched controls. The specific
aims of the proposed study are to 1) evaluate the efficacy of FANCI for improving functional
status following treatment using the FIM, 2) examine the impact of FANCI on broader outcome
measures of general emotional and behavioral functioning and productive activity in the
community as measured post-treatment and at 6-month follow-up, 3) examine contributions of
participant injury severity and cognitive status at time of treatment to treatment outcome
and treatment response, 4) examine contributions of treatment variables of session topic and
mastery, caregiver presence, and concurrent therapies on treatment outcome and treatment
response for inpatients with TBI. Primary outcome measure is the (FIM). We will secondarily
compare scores on the Disability Rating Scale (DRS), Glasgow Outcome Scale-Extended (GOSE),
Rehabilitation Intensity of Therapy Scale (RITS), and Frontal Systems Behavior Scale
(FRsBe). Our design is a parallel groups, single-blind, randomized, controlled trial. We
will enroll 150 (75 treatment, 75 control) participants. Inclusion Criteria: Mod to Sev TBI
based on time to commands, English speaker, Length of stay ≥ 5 days in acute BI
rehabilitation Unit, 18 years of age or older, ≥ 79 on GOAT.