Status:
COMPLETED
Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Disability, Independent Living, and Rehabilitation Research
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aims of this traumatic brain injury (TBI) study are: 1. to evaluate the short and long-term efficacy of two structured outpatient intervention programs, Resilience and Adjustment Intervention (RA...
Detailed Description
Participants will be assigned to either of two treatment groups: (1) Resilience and Adjustment Intervention (RAI), or (2) RAI+. After randomization, a second appointment will be scheduled. All partici...
Eligibility Criteria
Inclusion
- Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
- At least 3 months post-TBI.
Exclusion
- Active substance abusers (e.g., intoxicated at arrival to intake).
- Individuals at imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others, as judged by the investigators, will be excluded from the study.
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT03421964
Start Date
February 16 2018
End Date
May 31 2023
Last Update
March 27 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298