Clinical trial NCT06855186: Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C)
Official title: Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Traumatic Brain Injury (mTBI)
Keywords: concussion
brain injury
cognitive rehabilitation
military
adults
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine
Sponsor class: OTHER
Collaborators: name: Brooke Army Medical Center
name: Tripler Army Medical Center
First posted: 2025-03-03
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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: 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 (e.g., computer based cognitive rehabilitation).
* 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).

Primary outcomes:
measure: Common Concussive Cognitive Complaints (C4)
timeFrame: From baseline to 3 months post treatment
measure: Goal Attainment Scaling (GAS)
timeFrame: From treatment week 1 to 3 months post treatment
Secondary outcomes:
measure: Evaluate maintenance of treatment effects
timeFrame: From baseline to 3 months post treatment
Other outcomes:
measure: 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
timeFrame: From baseline to 3 months post treatment
Locations:
city: Wahiawa
country: United States
facility: Desmond T. Doss Health Clinic
state: Hawaii
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
Study officials:
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