Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)
NCT ID: NCT06855186
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
222 participants
INTERVENTIONAL
2025-09-18
2028-08-31
Brief Summary
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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.
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Detailed Description
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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)?
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
64 Years
ALL
No
Sponsors
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Brooke Army Medical Center
FED
Tripler Army Medical Center
FED
Henry M. Jackson Foundation for the Advancement of Military Medicine
OTHER
Responsible Party
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Locations
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Desmond T. Doss Health Clinic
Wahiawa, Hawaii, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Countries
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Central Contacts
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References
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Related Links
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DOD TBI Worldwide Numbers
VA/DoD Clinical Practice Guideline for the Management and Rehabilitation of Post-Acute Mild Traumatic Brain Injury
International Classification of Health Interventions (ICHI)
NIH Toolbox Cognition Battery
Other Identifiers
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C.2024.104d
Identifier Type: -
Identifier Source: org_study_id
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