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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
Who can join
Ages 18 to 64 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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).
About the study
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.
What is being tested
- Symptom-Targeted Approach to Rehabilitation for Concussion (behavioral)
Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Participants: 222 · Started: Sep 18, 2025
Contact the study team
- Marc Blaylock · Phone: 210-916-8693
- Kalawena N Kalehuawehe · Phone: 808-433-8553
Official record on ClinicalTrials.gov — NCT06855186
Locations in the U.S.
| Hawaii | Desmond T. Doss Health Clinic, Wahiawa |
| Texas | Brooke Army Medical Center, San Antonio |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.