In-Person for Concussion

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ConcussionManualized cognitive rehabilitation for mild traumatic brain injury (mTBI) - Procedure
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

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

1 of 3

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

1 of 3

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: Procedure
Telehealth
Procedure
Experimental Group · 1 Intervention: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) · Intervention Types: Procedure

Trial 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