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

Locations

2
Desmond T. Doss Health Clinic96786, WahiawaHawaii, United States
Brooke Army Medical Center78234, San AntonioTexas, United States

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