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

Part of paid clinical trials in Wahiawa, Hawaii.

Sponsor
Henry M. Jackson Foundation for the Advancement of Military Medicine
Study ID
NCT06855186
Status
Recruiting
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Conditions

  • Mild Traumatic Brain Injury (mTBI)

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Symptom-Targeted Approach to Rehabilitation for Concussion — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 18, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Common Concussive Cognitive Complaints (C4) [ Time Frame: From baseline to 3 months post treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Desmond T. Doss Health ClinicWahiawaHawaii96786-
Brooke Army Medical CenterSan AntonioTexas78234-

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By research site
Desmond T. Doss Health Clinic· Wahiawa, HIBrooke Army Medical Center· San Antonio, TX

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