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STAR-C for Long-Term Concussion Symptoms

This study is testing a program called Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C) to help people who have had a mild traumatic brain injury (mTBI), also known as a concussion, more than three months ago and are still experiencing cognitive (thinking) problems. STAR-C is a shortened version of a therapy that teaches strategies to manage these symptoms. Researchers want to see if STAR-C, delivered in person or through telehealth (like video calls), can reduce everyday cognitive complaints. They will compare STAR-C to a group that does not receive treatment. Success will be measured by how much your cognitive complaints improve and how well you achieve personal goals related to your symptoms. You may be able to join if you are 18-64 years old and have ongoing cognitive complaints from a past concussion. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 222 participants. It is a three-group study comparing in-person STAR-C, telehealth STAR-C, and a no-treatment control group.
What's involved
Outcomes will be assessed immediately after treatment, and then again one and three months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to three months after treatment.

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NCT06855186

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

Recruiting
NAAges 18–64InterventionalTreatment
Henry M. Jackson Foundation for the Advancement of Military Medicine
~222 participants
Updated 2026-01-08 on ClinicalTrials.gov
What's tested:Symptom-Targeted Approach to Rehabilitation for Concussion

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Common Concussive Cognitive Complaints (C4)
Measured over From baseline to 3 months post treatment
+1 more outcome measured

Conditions

Mild Traumatic Brain Injury (mTBI)

Explore related trials

Concussion

Where it's being run

2 sites across 2 states
Hawaii1
Texas1

Who to contact

Marc Blaylock
[email protected]
210-916-8693
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Common Concussive Cognitive Complaints (C4)From baseline to 3 months post treatment

    On the C4, patients are asked to "identify challenges that are new since your injury and affect your everyday functioning, so we can focus therapy on what is most important to you." For each question, the patient is asked to choose the number that shows how often this has caused problems for them in everyday life in the past two weeks. Responses are on a scale from 1 (not at all) to 5 (all the time). The reliability and validity of the C4 are acceptable (internal consistency of domains: 0.465 to 0.797; 4-week test-retest reliability of domains: 0.628 to 0.832; convergent validity with MMPI-3 Cognitive Complaints and Inefficiency scales and discriminant validity with MMPI-3 Activation and Eating Concerns scales).

  • Goal Attainment Scaling (GAS)From treatment week 1 to 3 months post treatment

    As described above in the Summary of ongoing relevant clinical trials, in each session, the patient and therapist collaborate to identify a desired outcome for the patient's target and then scale it using a 5-point rating system. The patient's current state relative to the target is assigned a 0 on the scale, achievement of the desired target is +2, partial achievement is +1, and achievement beyond expectations is +3. Success is defined as a GAS score of 2 or 3.