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Behavioural Intervention
Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C Trial)
N/A
Waitlist Available
Led By Blessen C Eapen, MD
Research Sponsored by South Texas Veterans Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment
Awards & highlights
No Placebo-Only Group
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Common Concussive Cognitive Complaints (C4) Inventory Change
Goal Attainment Scaling Change
Key Behaviors Change Inventory (KBCI)
+2 moreSecondary study objectives
Acceptability of Intervention Measure (AIM)- (Clinician)
Acceptability of Intervention Measure (AIM)- (Patient)
Center for Epidemiological Studies-Depression (CES-D)
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: TelehealthExperimental Treatment1 Intervention
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered via telehealth.
Group II: In-PersonExperimental Treatment1 Intervention
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered face-to-face.
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Who is running the clinical trial?
South Texas Veterans Health Care SystemLead Sponsor
18 Previous Clinical Trials
6,008 Total Patients Enrolled
Brooke Army Medical CenterFED
129 Previous Clinical Trials
27,579 Total Patients Enrolled
McMaster UniversityOTHER
918 Previous Clinical Trials
2,616,235 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
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Telehealth
- Group 2: In-Person
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.