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

NCT06855186 | Recruiting

• 1 other identifier: C.2024.104d
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

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)

Keywords

concussion; brain injury; cognitive rehabilitation; military; adults

Outcome Measures

Primary Outcomes (2)

• Common Concussive Cognitive Complaints (C4)

  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)

  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 Outcomes (1)

• Evaluate maintenance of treatment effects

  From baseline to 3 months post treatment

Other Outcomes (1)

• 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

  From baseline to 3 months post treatment

Study Arms (3)

No Treatment Waitlist

OTHER

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

In-Person STAR-C

OTHER

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

Telehealth STAR-C

OTHER

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

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.

In-Person STAR-C; No Treatment Waitlist; Telehealth STAR-C

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Brooke Army Medical Center: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Tripler Army Medical Center: collaborator

Study Sites (2)

Desmond T. Doss Health Clinic

Wahiawa, Hawaii, 96786, United States

RECRUITING

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Related Publications (58)

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Related Links

• 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

MeSH Terms

Conditions

Brain Concussion; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Marc Blaylock

CONTACT

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

Kalawena N Kalehuawehe

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 3, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Beginning after data collection ends with no end date
• 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;

Locations

US (2)