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.
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.
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).
Parallel
Symptom-Targeted Approach to Rehabilitation for Concussion
BehavioralThis 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.
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).
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.
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.
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
Question 3a: Determine what factors, if any, that may have prevented participants from achieving a ≥2 point C4 improvement at the end of treatment. Question 3b: Determine what factors, if any, that may have prevented participants from maintaining at ≥2 point C4 improvement at the 3-month follow-up. Question 3c: Determine what factors, if any, that may have prevented participants from achieving ≥2 out of 3 targets using GAS. Question 3d: Determine what factors, if any, that may have contributed to participants maintaining or exceeding targets (GAS) at the 3-month follow-up.
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Henry M. Jackson Foundation for the Advancement of Military Medicine
Lead sponsor
Brooke Army Medical Center
Collaborator
Tripler Army Medical Center
Collaborator
