Original article
Evaluation of the Short-Term Executive Plus Intervention for Executive Dysfunction After Traumatic Brain Injury: A Randomized Controlled Trial With Minimization

https://doi.org/10.1016/j.apmr.2013.08.005Get rights and content

Abstract

Objective

To determine whether the Short-Term Executive Plus (STEP) cognitive rehabilitation program improves executive dysfunction after traumatic brain injury (TBI).

Design

Randomized, waitlist controlled trial with minimization and blinded outcome assessment.

Setting

Community.

Participants

Participants with TBI and executive dysfunction (N=98; TBI severity 50% moderate/severe; mean time since injury ± SD, 12±14y; mean age ± SD, 45±14y; 62% women; 76% white).

Intervention

STEP program: 12 weeks (9h/wk) of group training in problem solving and emotional regulation and individual sessions of attention and compensatory strategies training.

Main Outcome Measures

Factor analysis was used to create a composite executive function measure using the Problem Solving Inventory, Frontal Systems Behavior Scale, Behavioral Assessment of the Dysexecutive Syndrome, and Self-Awareness of Deficits Interview. Emotional regulation was assessed with the Difficulties in Emotion Regulation Scale. The primary attention measure was the Attention Rating and Monitoring Scale. Secondary measures included neuropsychological measures of executive function, attention, and memory and measures of affective distress, self-efficacy, social participation, and quality of life.

Results

Intention-to-treat mixed-effects analyses revealed significant treatment effects for the composite executive function measure (P=.008) and the Frontal Systems Behavior Scale (P=.049) and Problem Solving Inventory (P=.016). We found no between-group differences on the neuropsychological measures or on measures of attention, emotional regulation, self-awareness, affective distress, self-efficacy, participation, or quality of life.

Conclusions

The STEP program is efficacious in improving self-reported post-TBI executive function and problem solving. Further research is needed to identify the roles of the different components of the intervention and its effectiveness with different TBI populations.

Section snippets

Overview

This study was a single-center, randomized, waitlist (WL) controlled trial using minimization with blinded outcome assessments that took place at the Mount Sinai Medical Center starting in January 2008. Enrollment ended in March 2012, and collection of primary outcome data concluded in June 2012. The Icahn School of Medicine at Mount Sinai Institutional Review Board approved the study. All participants provided written informed consent.

Participants

We recruited participants at the Mount Sinai Medical Center

Results

We screened 233 individuals of whom 98 met inclusion criteria and were randomized (fig 1). There were no significant baseline differences between the groups in injury severity, age, education, sex, race, marital status, or income (table 1). In addition, the groups were not significantly different at baseline on any of the outcome variables except the Woodcock-Johnson III Tests of Cognitive Ability auditory attention scale (table 2; supplemental table S2, available online only at //www.archives-pmr.org/

Discussion

The findings suggest that the STEP reduces executive dysfunction and improves problem solving. Participants reported significant positive changes in their ability to solve problems and engage in efficacious, goal-directed behavior in everyday life. The findings add to a small but growing body of evidence that intensive training in metacognitive skill, such as problem solving and emotional regulation, can benefit individuals with TBI-related executive dysfunction.6, 7, 8, 9, 61, 62, 63, 64, 65

Conclusions

This study has some important implications. Results support the efficacy of an intervention for ameliorating deficits in executive function, one of the most debilitating sequelae of TBI. Future trials should focus on identifying active ingredients in STEP that contribute to outcome76 and investigating effectiveness in different modalities (eg, individual treatment, online delivery) and with different populations with TBI where executive dysfunction is a substantive problem (eg, military service

Supplier

Acknowledgments

We thank the therapists and assessors and Vladimira Varbanova, BA, for her work as a research coordinator. We also thank Keith Cicerone, PhD, for his work monitoring treatment fidelity and Tausif Billah, BS, for his help in preparing the manuscript.

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    Current affiliation for Ashman, Shepherd Center, Atlanta, GA.

    Supported by the Centers for Disease Control and Prevention (grant no. 1R49CE001171-01).

    Clinical Trial Registration No.: NCT00627237.

    No commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a benefit on the authors or on any organization with which the authors are associated.

    †

    Deceased.

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    Copyright © 2014 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.