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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHenry M. Jackson Foundation for the Advancement of Military Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Symptom-Targeted Approach to Rehabilitation for Concussion

Treatment groups

222 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Henry M. Jackson Foundation for the Advancement of Military Medicine

Lead sponsor

Brooke Army Medical Center

Collaborator

Tripler Army Medical Center

Collaborator