Mild Traumatic Brain Injury Clinical Trial
Official title:
Social Work Intervention for Adults With Mild Traumatic Brain Injury: SWIFT Pilot Study
Mild traumatic brain injury (mTBI) is a prevalent and costly public health problem with
disabling consequences. More than one million civilians with mTBI are treated in US
hospitals and emergency departments each year (Faul, et al., 2010). While the exact number
is debated, approximately 10-15% of individuals with mTBI will experience prolonged and
disabling post-concussive symptoms (Stranjalis, et al., 2008; Ruff and Weyer Jamora, 2009),
and 34% will experience a psychiatric illness in the first year after injury (Fann, et al.,
2004). In addition, at least 188,270 military service members sustained a TBI from 2000 to
mid August 2010, and nearly 77% of these injuries were mild (Defense and Veterans Brain
Injury Center, 2010). Many individuals require treatment for resulting mTBI symptoms.
The proposed study builds on preliminary research conducted by the investigators to develop
and test the effectiveness of a social work delivered education and reassurance intervention
for adults with mTBI (SWIFT-Acute) against usual care. The proposed study will assess
acceptability and obtain preliminary effectiveness data for an enhanced social work
assessment and intervention for adults with mTBI (SWIFT) discharged from the Emergency
Department (ED). SWIFT includes early education, reassurance, coping strategies, resources
and a brief alcohol use intervention in the ED plus follow up telephone counseling, needs
assessment and case management referral to necessary services. The intervention targets
cognitive, physical, psychiatric and functional outcomes; specifically, post-concussive
symptoms, depression, anxiety, posttraumatic stress disorder, alcohol use, community
functioning and successful linkage to community resources.
It is hypothesized that SWIFT will be acceptable to patients and that participants in the
SWIFT group will report superior outcomes on measures of post-concussive symptoms,
depression and anxiety, alcohol use and community functioning and will report increased
successful linkages to needed resources when compared to the SWIFT-Acute group.
The specific aims of the study are:
1. Implement an innovative social work intervention for adults with mTBI (SWIFT).
2. Assess acceptability of SWIFT using qualitative interviews with participants.
3. Assess preliminary effectiveness of SWIFT compared to SWIFT-Acute alone on reduction or
prevention of post-concussive symptoms, depression, anxiety, posttraumatic stress
disorder (PTSD) symptoms, and alcohol use, and on improvement of community functioning
and successful linkage to community resources. 80 participants will be randomized to
receive SWIFT or SWIFT-Acute. Preliminary intervention effectiveness will be assessed
using standard measures of post-concussive symptoms, the primary outcome, depression,
anxiety, PTSD, alcohol use, and community functioning. A structured survey will be used
to assess linkage to community resources.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04372797 -
Standardized Instruments to Provide Diagnostic and Prognostic Information in Mild Traumatic Brain Injury (mTBI)
|
N/A | |
Completed |
NCT01903525 -
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
|
Phase 1 | |
Completed |
NCT01847040 -
Deployment Related Mild Traumatic Brain Injury (mTBI)
|
||
Completed |
NCT03678077 -
Trends in Cohabitation Status, Academic Achievement and Socio-economic Indicators After Mild Traumatic Brain Injury
|
||
Recruiting |
NCT05682677 -
Combined Neuromodulation and Cognitive Training for Post-mTBI Depression
|
N/A | |
Terminated |
NCT03345550 -
OPTIMA-TBI Pilot Study
|
Phase 2 | |
Completed |
NCT05095012 -
RECOVER Clinical Pathway for Pediatric Concussion
|
N/A | |
Recruiting |
NCT05886400 -
The Effects of Environmental Distractions on SCAT6 Outcomes
|
N/A | |
Recruiting |
NCT05262361 -
Persistent Post-Concussion Symptoms With Convergence Insufficiency
|
N/A | |
Active, not recruiting |
NCT03892291 -
Objective Dual-task Turning Measures for Return-to-duty Assessments
|
||
Completed |
NCT03688984 -
Treatment of Insomnia for Adolescents With Mild Traumatic Brain Injury
|
N/A | |
Completed |
NCT02057081 -
Multifamily Group to Reduce Marital Conflict and Disability in Veterans With mTBI
|
N/A | |
Recruiting |
NCT06233851 -
t-BIOMAP : Prospective Paediatric Cohort Study of Blood Biomarkers in mTBI
|
||
Completed |
NCT02844946 -
One-Day Life Skills Workshop for Veterans With TBI, Pain and Psychopathology
|
N/A | |
Completed |
NCT04641767 -
BIOmarkers of TRAumatic Brain Injury Spain (BIOTRABIS)
|
||
Recruiting |
NCT06112093 -
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
|
N/A | |
Recruiting |
NCT03819608 -
Neuromodulation and Neurorehabilitation for mTBI Plus PTSD
|
N/A | |
Withdrawn |
NCT00580918 -
Functional MRI Study of Attention in Normal Controls and Traumatic Brain Injured Patients
|
||
Completed |
NCT03319966 -
Eyetracking and Neurovision Rehabilitation of Oculomotor Dysfunction in Mild Traumatic Brain Injury
|
||
Recruiting |
NCT03846830 -
Incremental Velocity Error as a New Treatment in Vestibular Rehabilitation
|
N/A |