NCT06855186NARecruiting

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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Start Date

9/18/2025

Completion Date

8/31/2028

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.

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)?

Eligibility Criteria

Age Range: 18 years to 64 years

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).

Interventions

BEHAVIORAL

Symptom-Targeted Approach to Rehabilitation for Concussion

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Conditions

Mild Traumatic Brain Injury (mTBI)

Locations

Desmond T. Doss Health Clinic

Wahiawa, Hawaii 96786

United States

Brooke Army Medical Center

San Antonio, Texas 78234

United States