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

Henry M. Jackson Foundation for the Advancement of Military Medicine222 enrolled

Overview

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.

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)?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

Symptom-Targeted Approach to Rehabilitation for ConcussionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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 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). * 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).

Outcomes

Primary Outcomes

Common Concussive Cognitive Complaints (C4)

On the C4, patients are asked to "identify challenges that are new since your injury and affect your everyday functioning, so we can focus therapy on what is most important to you." For each question, the patient is asked to choose the number that shows how often this has caused problems for them in everyday life in the past two weeks. Responses are on a scale from 1 (not at all) to 5 (all the time). The reliability and validity of the C4 are acceptable (internal consistency of domains: 0.465 to 0.797; 4-week test-retest reliability of domains: 0.628 to 0.832; convergent validity with MMPI-3 Cognitive Complaints and Inefficiency scales and discriminant validity with MMPI-3 Activation and Eating Concerns scales).

Time frame: From baseline to 3 months post treatment

Goal Attainment Scaling (GAS)

As described above in the Summary of ongoing relevant clinical trials, in each session, the patient and therapist collaborate to identify a desired outcome for the patient's target and then scale it using a 5-point rating system. The patient's current state relative to the target is assigned a 0 on the scale, achievement of the desired target is +2, partial achievement is +1, and achievement beyond expectations is +3. Success is defined as a GAS score of 2 or 3.

Time frame: From treatment week 1 to 3 months post treatment

Secondary Outcomes

Evaluate maintenance of treatment effects

Question 2a: At the 3-month follow-up, determine the proportion of in-person STAR-C participants with ≥2 points C4 improvement post treatment maintained their improvement using contingency table or McNemar test. Question 2b: At the 3-month follow-up, determine the proportion of telehealth STAR-C participants with ≥2 points C4 improvement post treatment maintained their improvement using contingency table or McNemar test. Question 2c: At the 1-month and 3-month follow-ups, describe rates of maintaining ≥2 points C4 improvement for the in-person and telehealth STAR-C groups.