Trial Summary
What is the purpose of this trial?
Objective: This 3-year multisite RCT will determine the effectiveness of a targeted multidomain intervention (T-MD) (anxiety/mood, cognitive, migraine, ocular, vestibular; and sleep, autonomic) compared to usual care (behavioral management) in military-aged civilians with complex mTBI.
Research Team
AP
Anthony P Kontod, PhD
Principal Investigator
University of Pittsburgh
Eligibility Criteria
This trial is for military-aged civilians (18-49) who've had a mild traumatic brain injury (mTBI) with symptoms like confusion, dizziness, or memory issues. They must have been diagnosed within the past 8 days to 6 months and have a Glascow coma scale score of at least 13. Exclusions include those with certain vestibular or neurological disorders, severe TBI history, pregnancy, legal actions related to mTBI, or previous participation in this study.Inclusion Criteria
I have complex symptoms from a brain injury in areas like mood, thinking, or sleep.
I have experienced symptoms like confusion, dizziness, or memory problems possibly due to a mild brain injury.
You must have a Glascow coma scale (GCS) score of at least 13.
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Exclusion Criteria
I haven't been treated at the study sites in the last 2 years.
Currently on workman's compensation
I have been diagnosed with heart, blood vessel, or brain blood flow problems.
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Treatment Details
Interventions
- Behavioral Management (Behavioral Intervention)
- Targeted Multidomain (Behavioral Intervention)
Trial OverviewThe study compares targeted multidomain interventions focusing on areas such as anxiety/mood, cognitive functions, migraines etc., against usual behavioral management care. It's designed to see if these specialized treatments are more effective for people with complex mTBI symptoms.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: T-MD Intervention GroupExperimental Treatment1 Intervention
Participants will be prescribed 1+ interventions tailored to affected domains.Anxiety/Mood-Cog beh therapy(CBT) for maladaptive beliefs/avoidance/coping behaviors. Graded exposure/activity/relaxation exercises, cognitive restructuring. Cognitive-Accommodations for reduced work/school time/delayed deadlines, more frequent/longer cognitive rest during symptom-provoking activities. Migraine/Headache: Education, relaxation training/mindfulness based therapy. Ocular-Exercises for ocular symptoms, near point convergence, may include Brock string, pencil push-ups, fixation, saccade tracking, pursuits. Sleep-Sleep regulation/hygiene. Mindfulness-based training, morning physical activity, CBT.Vestibular-Exercises for dizziness, visual motion sensitivity, gait, imbalance that may include gaze stability, visual habituation, static and dynamic balance/gait.Autonomic-Graded aerobic exercise. Perform daily aerobic exercise, goal 80% HR max on a stationary bike/treadmill/walking/jogging.
Group II: Behavioral ManagementActive Control1 Intervention
Participants in control group will receive standardized behavioral management strategies including: activity, hydration, nutrition, sleep, and stress management strategies. These strategies provide general methods to manage concussion symptoms and regulate daily activities to assist in the recovery of concussion. Clinicians will discuss and review a behavioral strategies handout with each participant and answer any questions they may have about the information in the handout. Contact time between clinicians and patients will be similar to avoid effects associated with more or less contact time.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Trials
1,820
Recruited
16,360,000+
United States Department of Defense
Collaborator
Trials
940
Recruited
339,000+
Inova Health Care Services
Collaborator
Trials
80
Recruited
22,700+