Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)

Recruiting now · Not applicable

Conditions studied: Mild Traumatic Brain Injury (mTBI)

In brief

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.

Key facts

Study ID

NCT06855186

Run by

Henry M. Jackson Foundation for the Advancement of Military Medicine

People needed

222

Starts

2025-09-18

Expected to finish

2028-08-31

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older, up to 64. 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 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.

You may not qualify if…

• 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).

Where it is running

• Desmond T. Doss Health Clinic — Wahiawa, Hawaii, United States (enrolling)
• Brooke Army Medical Center — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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