Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)
Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control
Henry M. Jackson Foundation for the Advancement of Military Medicine
222 participants
Sep 18, 2025
INTERVENTIONAL
Conditions
Summary
Purpose: Investigators propose a three-arm RCT across two military treatment facilities:1) in-person STAR-C, 2) telehealth STAR-C, and 3) no treatment control. Outcomes will be assessed immediately and at one- and three-months post treatment. Hypothesis/Objectives: STAR-C, delivered in-person and via telehealth, will be effective in decreasing everyday cognitive complaints among patients with a history of mTBI. Effectiveness will be moderated by patient characteristics. Stakeholder feedback will yield a process map for broad implementation of STAR-C in varied clinical environments.
Eligibility
Inclusion Criteria3
- mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously.
- a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints.
- 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.
Exclusion Criteria9
- History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines.
- Lifetime diagnosis of schizophrenia or other psychotic/thought disorder.
- Current participation in intensive behavioral health treatment (≥3 appointments /encounters per week) for any psychiatric or substance use disorder.
- Current participation in other treatments that target cognition within the last two weeks (i.e., healthcare provider-prescribed cognitive rehabilitation in a group or individual format of any time duration or involving digital/game-based format of more than 4 hours per week).
- History of a neurological disease affecting cognitive function, other than mild TBI, such as multiple sclerosis, stroke, brain tumor, or Parkinson Disease.
- Current, active suicidal or homicidal ideation.
- Daily use of narcotic pain medications.
- Lack of access to technology or internet/cell phone service that supports telemedicine.
- Current participation in other therapy targeting cognition (Note: This is not the same as Cognitive Behavioral Therapy/CBT which addresses psychological issues and may continue during participation in this research project).
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Interventions
This study is looking at a shortened version of a therapist-direct cognitive rehabilitation intervention, known as STAR-C. STAR-C is focused on strategy use, and for strategy use to become a habit the person must have the opportunity for high-dose spaced practice. Thus, in STAR-C each session includes opportunities for repeated practice and participants schedule practice times between sessions. Sometimes a new strategy requires learning new facts, in which case the clinician chooses ingredients such as self-quizzing or comparing and contrasting outcomes, which are effective for learning new facts and concepts.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06855186