NCT06855186

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

Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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)?

Conditions

• Mild Traumatic Brain Injury (mTBI)

Interventions

Type	Name	Description
BEHAVIORAL	Symptom-Targeted Approach to Rehabilitation for Concussion	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.

Timeline

• Start date: 2025-09-18
• Primary completion: 2026-12-31
• Completion: 2028-08-31
• First posted: 2025-03-03
• Last updated: 2026-01-08

Locations

2 sites across 1 country: United States