Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
ID06855186

Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): Randomized Trial Comparing In-Person, Telehealth, and Wait List Control

Led by Henry M. Jackson Foundation for the Advancement of Military Medicine · Updated on 2026-01-08

222

Participants Needed

2

Research Sites

87 weeks

Total Duration

On this page

Sponsors

H

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead Sponsor

B

Brooke Army Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C) in adults with a history of mild traumatic brain injury (mTBI). The study aims to compare the effects of in-person STAR-C, telehealth STAR-C, and no treatment on reducing everyday cognitive complaints. The trial also seeks to understand how patient characteristics affect treatment response and to develop a plan for wider use of STAR-C in clinical settings. Participants are randomly assigned to one of three groups: a four-week no treatment waitlist, in-person cognitive rehabilitation, or telehealth cognitive rehabilitation. Those receiving treatment will have up to nine sessions plus a wrap-up session over several weeks. Therapy focuses on compensatory strategies, personalized goals, and homework practice to help make strategy use a habit. The wrap-up session helps participants plan to maintain their progress. During the study, participants complete questionnaires and assessments at baseline, immediately post-treatment, and at one- and three-month follow-ups. Outcome measures include the Common Concussive Cognitive Complaints (C4) and Goal Attainment Scaling (GAS) to track improvement and maintenance. Researchers will also gather feedback from patients and clinicians to guide future implementation. The total duration of participation varies but includes treatment and follow-up visits over several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of mild traumatic brain injury (mTBI) sustained over 3 months ago, defined by VA/DoD Clinical Practice Guidelines
  • Score of 2, 3, or 4 on any of the four Cognitive items on the Neurobehavioral Symptom Inventory (NSI)
  • Reading ability at or above a sixth-grade level on the Word Reading Subtest of the Wide Range Achievement Test
  • Age between 18 and 64 years
Not Eligible

You will not qualify if you...

  • History of moderate, severe, or penetrating traumatic brain injury (TBI) as defined by DoD/VA guidelines
  • Lifetime diagnosis of schizophrenia or other psychotic or thought disorders
  • Currently receiving intensive behavioral health treatment with three or more appointments per week
  • Participation in other cognitive treatments within the last two weeks exceeding 4 hours per week
  • History of neurological diseases affecting cognition other than mild TBI (e.g., multiple sclerosis, stroke, brain tumor, Parkinson Disease)
  • Current active suicidal or homicidal thoughts
  • Daily use of narcotic pain medications
  • Lack of access to technology or internet/cell phone service supporting telemedicine
  • Current participation in other therapies targeting cognition (excluding Cognitive Behavioral Therapy)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Wait-list Control

Duration - 4 weeks

Participants randomized to this group will wait for 4 weeks without treatment while maintaining their current treatments. They will complete questionnaires about their symptoms during this time.

1 visit (in-person or remote) at end of wait period

In-Person Treatment

Duration - Up to 4 weeks (up to nine sessions plus one wrap-up session)

Participants receive individual in-person cognitive rehabilitation treatment with up to three sessions per week focusing on compensatory strategies, personalized targets, and weekly homework assignments. The treatment ends with a wrap-up session to plan maintenance.

Up to 10 visits (in-person)

Telehealth Treatment

Duration - Up to 4 weeks (up to nine sessions plus one wrap-up session)

Participants receive individual cognitive rehabilitation treatment via telemedicine with up to three sessions per week focusing on compensatory strategies, personalized targets, and weekly homework assignments. The treatment ends with a wrap-up session to plan maintenance.

Up to 10 visits (remote)

Follow-up

Duration - 3 months

Participants are followed for 3 months after treatment to evaluate maintenance of treatment effects and overall progress.

1 visit at 3 months post treatment

Trial Site Locations

Total: 2 locations

1

Desmond T. Doss Health Clinic

Wahiawa, Hawaii, United States, 96786

Actively Recruiting

2

Brooke Army Medical Center

San Antonio, Texas, United States, 78234

Actively Recruiting

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Research Team

M

Marc Blaylock

K

Kalawena N Kalehuawehe

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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