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

January 7, 2026 updated by: Henry M. Jackson Foundation for the Advancement of Military Medicine

Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Specific Aim 1 (primary for RCT): To evaluate effectiveness of STAR-C.

Hypothesis 1a: In-Person STAR-C will lead to a greater decrease in everyday cognitive complaints (C4) compared to wait-list control.

Hypothesis 1b: Tele STAR-C will lead to a greater decrease in everyday cognitive complaints (C4) compared to wait-list control.

Specific Aim 2 (secondary): To evaluate maintenance of treatment effects using a practice based evidence approach.

Question 2a: What proportion of in-person STAR-C treatment effects (C4 and GAS) will be maintained at the 3-month follow-up?

Question 2b: What proportion of telehealth STAR-C treatment effects (C4 and GAS) will be maintained at the 3-month follow-up?

Specific Aim 3 (exploratory): To explore factors associated with heterogeneity in treatment response.

Question 3a: What factors prevented participants from achieving a ≥2-point improvement on the C4?

Question 3b: What factors prevented participants from maintaining ≥2-point improvement on the C4?

Question 3c: What factors prevented participants from achieving ≥2 out of 3 targets using GAS?

Question 3d: What factors contributed to participants maintaining or exceeding targets (GAS) at the 3-month follow-up?

Specific Aim 4 (implementation): Use stakeholder input (to include clinicians, administrators, and patients) from capacity assessment and after-action review to generate an implementation package for clinics interested in STAR-C.

Question 4: For what proportion of patients will clinicians rate STAR-C as acceptable, appropriate, and feasible (AIM/IAM/FIM)?

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Wahiawa, Hawaii, United States, 96786
        • Recruiting
        • Desmond T. Doss Health Clinic
    • Texas
      • San Antonio, Texas, United States, 78234
        • Recruiting
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Behavioral: 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.
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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Common Concussive Cognitive Complaints (C4)
Time Frame: 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).
From baseline to 3 months post treatment
Goal Attainment Scaling (GAS)
Time Frame: 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.
From treatment week 1 to 3 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate maintenance of treatment effects
Time Frame: From baseline to 3 months post treatment
Question 2a: At the 3-month follow-up, determine the proportion of in-person STAR-C participants with ≥2 points C4 improvement post treatment maintained their improvement using contingency table or McNemar test. Question 2b: At the 3-month follow-up, determine the proportion of telehealth STAR-C participants with ≥2 points C4 improvement post treatment maintained their improvement using contingency table or McNemar test. Question 2c: At the 1-month and 3-month follow-ups, describe rates of maintaining ≥2 points C4 improvement for the in-person and telehealth STAR-C groups.
From baseline to 3 months post treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To explore factors associated with heterogeneity in treatment response. Statistical approach will be determined after potential factors are evaluated for differences between the RCT arms
Time Frame: From baseline to 3 months post treatment

Question 3a: Determine what factors, if any, that may have prevented participants from achieving a ≥2 point C4 improvement at the end of treatment.

Question 3b: Determine what factors, if any, that may have prevented participants from maintaining at ≥2 point C4 improvement at the 3-month follow-up. Question 3c: Determine what factors, if any, that may have prevented participants from achieving ≥2 out of 3 targets using GAS. Question 3d: Determine what factors, if any, that may have contributed to participants maintaining or exceeding targets (GAS) at the 3-month follow-up.
From baseline to 3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborators

Brooke Army Medical Center
Tripler Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

August 31, 2028

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

February 25, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C.2024.104d

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Common Concussive Cognitive Complaints (C4); Goal Attainment Scaling (GAS); Audio recordings; Patient Characterization Measures (headache, sleep problems, dizziness, musculoskeletal injury and pain, medications, and use of commercial brain games); Neurobehavioral Symptom Inventory (NSI); Key Behaviors Change Inventory (KBCI); Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5); Patient Health Questionnaire (PHQ-9); Veterans RAND 36 Item Health Survey (VR-36); Epworth Sleepiness Scale (ESS); Feasibility of Intervention Measure (FIM)/Intervention Appropriateness Measure (IAM)/Acceptability of Intervention Measure (AIM); Self Efficacy for Symptom Management (SESx); NIH Toolbox - cognition; Memory Complaints Inventory (MCI); Inventory of Problems (IOP)

IPD Sharing Time Frame

Beginning after data collection ends with no end date

IPD Sharing Access Criteria

Brain Injury Rehabilitation Service at Brooke Army Medical Center, Brain Injury Rehabilitation Service at Desmond T. Doss Health Clinic and McMaster University will be sent de-identified data that will be transmitted using DoD SAFE, which is a DoD endorsed platform for transferring data securely; De-identified data will be uploaded directly to Federal Interagency Traumatic Brain Injury Research (FITBIR) database;

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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