Symptom-Targeted Approach to Rehabilitation for Concussion

Completed · Not applicable

Conditions studied: Mild Traumatic Brain Injury

In brief

Throughout the course of the wars in Iraq and Afghanistan, more than 250,000 service members sustained traumatic brain injuries, mostly characterized as mild traumatic brain injuries (mTBI) or concussions. While most with mTBI recover over days to weeks, a significant percentage continue to experience post-concussive symptoms such as headaches, cognitive difficulties, and dizziness for months to years. As a result, treatment of post-concussive symptoms after mTBI is of significant importance in the Department of Defense and Veterans healthcare systems. Several studies have shown that cognitive rehabilitation can be effective for individuals with mTBI, including Service Members and Veterans with post concussive symptoms. Cognitive rehabilitation is a type of treatment in which patients work with a therapist to improve everyday memory and thinking skills and develop strategies to reduce the impact of cognitive difficulties in their everyday lives. While these treatments have great potential benefits, protocols studied to date are time intensive, requiring up to 60 hours of treatment. These time demands are impractical for many Service Members and Veterans, and place a time-burden on clinics providing the treatment. The current study proposes to identify key ingredients of an evidence-based cognitive rehabilitation protocol to develop a streamlined version that is feasible and acceptable to Service Members and Veterans. This briefer protocol will increase the number of Service Members and Veterans who can access treatment. To accomplish this goal the investigators will first spend six months analyzing manualized treatments from a successful cognitive rehabilitation intervention developed for Service Members. The investigators will analyze manuals using a framework developed to identify active ingredients in rehabilitation. Based on those results the investigators will develop a manualized streamlined treatment protocol, which the investigators will deliver to 25 Service Members and 50 Veterans over 18 months in person or via telehealth. The investigators will determine feasibility and acceptability of this intervention, and collect preliminary efficacy data. The project addresses access to therapy services and enhanced treatment compliance, a key barrier to participation in cognitive rehabilitation by Veterans and Service Members with TBI. Additionally, although this study focuses on Service Members and Veterans with mTBI, the investigators expect that this streamlined intervention can also be translated to civilian populations with mTBI.

Key facts

Study ID: NCT05091970
Run by: South Texas Veterans Health Care System
People needed: 58
Starts: 2021-11-10
Expected to finish: 2023-10-30
Last updated by the study team: 2025-05-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury (CPG; Corrigan \& Bogner, 2007) sustained in any context (deployment-related or non-deployment-related) and at any time longer than 6 months previously;
A score of 3, 4, or 5 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints; and
A score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials.
All individuals in this study population must meet all of the inclusion criteria in order to be eligible to participate in the study

You may not qualify if…

History of TBI (any severity) within 6 months of enrollment.
History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
Lifetime diagnosis of schizophrenia or other psychotic disorder.
Current participation in intensive behavioral health treatment (>5 appointments/encounters per week) for major depressive disorder, post-traumatic stress disorder (PTSD), bipolar disorder, or substance-related disorder.
History of a neurological disease other than mild TBI such as multiple sclerosis, cerebral vascular accident, brain tumor, neurodegenerative disease, or neuro-motor disorder.
Current, active suicidal or homicidal ideation.
A score of <45 on Trial 2 of the Test of Memory Malingering, or a Validity 10 score of >22 from the NSI, to exclude individuals who demonstrate suboptimal effort or potential invalid self-reporting of symptoms.
Daily use of narcotic pain medications.
All individuals in this study population meeting any of the exclusion criteria at baseline will be excluded from study participation.

Where it is running

Brooke Army Medical Center — San Antonio, Texas, United States
South Texas Veterans Health Care System — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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