Recruiting

STAR-C

Sponsor:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Code:

NCT06855186

Conditions

Mild Traumatic Brain Injury (mTBI)

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Symptom-Targeted Approach to Rehabilitation for Concussion

Study Details

Brief 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.

Conditions

Mild Traumatic Brain Injury (mTBI)

Study ID

NCT06855186

Start date

Sep 18, 2025

Status verified date

Jan, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

222 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: No Treatment Waitlist

Individuals randomized to this arm will go for 4 weeks without treatment. During this time, participants will be asked to remain stable on treatments that they are already receiving for their concussive symptoms; that is and should not start a new treatment or change their medication. At the end of the 4-week wait, participant's will be asked about any changes to treatments that they have received during this time, and participants will be asked to complete questionnaires. This visit can be complete in person or remotely. Participants will be randomized into the in-person or telemedicine group.

other: In-Person STAR-C

Individuals assigned to this treatment will receive in-person individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.

other: Telehealth STAR-C

Individuals assigned to this treatment will receive individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists via a telemedicine format. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.

Interventions

Symptom-Targeted Approach to Rehabilitation for Concussion

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.

Primary outcome measure

  • Common Concussive Cognitive Complaints (C4) [ Time Frame: From baseline to 3 months post treatment ]
  • Goal Attainment Scaling (GAS) [ Time Frame: From treatment week 1 to 3 months post treatment ]

Central Contacts and Locations

Central contacts

Marc Blaylock

210-916-8693marc.j.blaylock.ctr@health.mil

Kalawena N Kalehuawehe

808-433-8553kalawena.n.kalehuawehe.ctr@health.mil

Locations

Desmond T. Doss Health Clinic

Recruiting

Wahiawa, Hawaii, United States, 96786

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

More Information

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • concussion
  • brain injury
  • cognitive rehabilitation
  • military
  • adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Henry M. Jackson Foundation for the Advancement of Military Medicine on 2026-01-08.