Evaluation of the short-term executive plus intervention for executive dysfunction after traumatic brain injury: a randomized controlled trial with minimization

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.

Trial registration: ClinicalTrials.gov NCT00627237.

Keywords: APT-II; Attention Process Training, Second Edition; Brain injuries; Brain injury, chronic; Cognition disorders; Cognitive therapy; FrSBe; Frontal Systems Behavior Scale; Rehabilitation; STEP; Short-Term Executive Plus; TBI; WCST; WL; Wisconsin Card Sorting Test computer version 4; traumatic brain injury; waitlist.