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

Henry M. Jackson Foundation for the Advancement of Military Medicine

Status: Not yet enrolling

Conditions: Mild Traumatic Brain Injury (mTBI)

Treatments: Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06855186

C.2024.104d

Details and patient eligibility

About

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.

Full 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)?

Enrollment: 222 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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222 participants in 3 patient groups

No Treatment Waitlist

Other group

Description:

Individuals randomized to this arm will go for 4 weeks without treatment. During this time, participants will be asked to remain stable on treatments that they are already receiving for their concussive symptoms; that is and should not start a new treatment or change their medication. At the end of the 4-week wait, participant's will be asked about any changes to treatments that they have received during this time, and participants will be asked to complete questionnaires. This visit can be complete in person or remotely. Participants will be randomized into the in-person or telemedicine group.

Treatment:

Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion

In-Person STAR-C

Other group

Description:

Individuals assigned to this treatment will receive in-person individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.

Treatment:

Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion

Telehealth STAR-C

Other group

Description:

Individuals assigned to this treatment will receive individual cognitive rehabilitation treatment conducted by credentialed speech or occupational therapists via a telemedicine format. Participants will complete up to three sessions per week (approximately 50 minutes each) for up to nine sessions plus one wrap up session. The treatment will include a focus on compensatory strategies and weekly homework assignments. Participants will work on personalized targets and assignments. The treatment will end with one wrap up session where participants will put together a plan for maintenance of what they have learned with their therapist's help.

Treatment:

Behavioral: Symptom-Targeted Approach to Rehabilitation for Concussion