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

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.

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)?

Interventions

• 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

Primary outcome measures

• Common Concussive Cognitive Complaints (C4) [Time frame: From baseline to 3 months post treatment]
• Goal Attainment Scaling (GAS) [Time frame: From treatment week 1 to 3 months post treatment]

Secondary outcome measures (1)

• Evaluate maintenance of treatment effects [Time frame: From baseline to 3 months post treatment]

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 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

• Desmond T. Doss Health Clinic — Wahiawa
• Brooke Army Medical Center — San Antonio

Publications

• Cicerone KD, Azulay J. Perceived self-efficacy and life satisfaction after traumatic brain injury. J Head Trauma Rehabil. 2007 Sep-Oct;22(5):257-66. doi: 10.1097/01.HTR.0000290970.56130.81. PMID 17878767
• Corrigan JD, Bogner J. Initial reliability and validity of the Ohio State University TBI Identification Method. J Head Trauma Rehabil. 2007 Nov-Dec;22(6):318-29. doi: 10.1097/01.HTR.0000300227.67748.77. PMID 18025964
• Scheffler B, Schimbock F, Scholer A, Rosner K, Spallek J, Kopkow C. Tailored GuideLine Implementation in STrokE Rehabilitation (GLISTER) in Germany. Protocol of a Mixed Methods Study Using the Behavior Change Wheel and the Theoretical Domains Framework. Front Neurol. 2022 Jul 27;13:828521. doi: 10.3389/fneur.2022.828521. eCollection 2022. PMID 35968277
• Gromatsky M, Sullivan SR, Mitchell EL, Spears AP, Edwards ER, Goodman M. Feasibility and acceptability of VA CONNECT: Caring for our nation's needs electronically during the COVID-19 transition. Psychiatry Res. 2021 Feb;296:113700. doi: 10.1016/j.psychres.2020.113700. Epub 2020 Dec 31. PMID 33422845
• Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459
• Kendzerska TB, Smith PM, Brignardello-Petersen R, Leung RS, Tomlinson GA. Evaluation of the measurement properties of the Epworth sleepiness scale: a systematic review. Sleep Med Rev. 2014 Aug;18(4):321-31. doi: 10.1016/j.smrv.2013.08.002. Epub 2013 Aug 22. PMID 24135493
• Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540. PMID 1798888
• Kazis LE, Ren XS, Lee A, Skinner K, Rogers W, Clark J, Miller DR. Health status in VA patients: results from the Veterans Health Study. Am J Med Qual. 1999 Jan-Feb;14(1):28-38. doi: 10.1177/106286069901400105. PMID 10446661

Identifiers

NCT: NCT06855186 · C.2024.104d

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗