Study Summary
This trial will analyze manualized treatments from a successful cognitive rehabilitation intervention to develop a streamlined version that is more feasible for Veterans and Service Members with TBI.
Eligible Conditions
- Concussion
Treatment Effectiveness
Effectiveness Progress
Study Objectives
5 Primary · 8 Secondary · Reporting Duration: Treatment session 1(week 1), Treatment session 2 (week 1), Last Treatment session(week 3), 1 week post-treatment, 3 months post-treatment
Week 12
Center for Epidemiological Studies-Depression (CES-D)
Epworth Sleepiness Scale - Adult Version (ESS)
Key Behaviors Change Inventory (KBCI)
Neurobehavioral Symptom Inventory (NSI) Change
PTSD Checklist 5 (PCL-5)
Patient Global Impression of Change (PGIC)
Veterans Rand 36-Item Health Survey (VR-36)
Week 12
Common Concussive Cognitive Complaints (C4) Inventory Change
Week 3
Acceptability of Intervention Measure (AIM)- (Clinician)
Feasibility of Intervention Measure (FIM)
Intervention Appropriateness Measure (IAM)
Month 3
Acceptability of Intervention Measure (AIM)- (Patient)
Week 12
Goal Attainment Scaling Change
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
In-Person
1 of 2
Telehealth
1 of 2
Experimental Treatment
75 Total Participants · 2 Treatment Groups
Primary Treatment: In-Person · No Placebo Group · N/A
In-Person
Procedure
Experimental Group · 1 Intervention: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) · Intervention Types: ProcedureTelehealth
Procedure
Experimental Group · 1 Intervention: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) · Intervention Types: ProcedureTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment
Who is running the clinical trial?
South Texas Veterans Health Care SystemLead Sponsor
17 Previous Clinical Trials
5,689 Total Patients Enrolled
Brooke Army Medical CenterFED
110 Previous Clinical Trials
26,965 Total Patients Enrolled
McMaster UniversityOTHER
801 Previous Clinical Trials
1,727,802 Total Patients Enrolled
Blessen C Eapen, MDPrincipal InvestigatorSouth Texas Veterans Health Care System
Doug B Cooper, PhDPrincipal InvestigatorSouth Texas Veterans Health Care System
Amy O. Bowles, MDPrincipal InvestigatorBrooke Army Medical Center
Eligibility Criteria
Age 18 - 65 · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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