Efficacy of Intervention of Participation and Executive Functions (I-PEX) for Adults Following Traumatic Brain Injury: A Preliminary Pilot Randomized Controlled Trial

Background Participation restrictions following traumatic brain injury are associated with executive function (EF) deficits (EFDs). The subacute recovery phase’s specific characteristics (enhanced brain plasticity and impaired self-awareness) and contextual factors (inpatient setting) warrant adjusting cognitive rehabilitation protocols. The Intervention of Participation and Executive Functions (I-PEX) was designed to improve EFDs during subacute inpatient rehabilitation. Objective To investigate the I-PEX’s preliminary efficacy to improve EFDs during the performance of complex daily activities and enhance self-awareness, cognitive self-efficacy, participation, and quality of life postdischarge. Methods A pilot pre-, post-, and follow-up double-blind randomized controlled trial with 25 participants randomly allocated to the I-PEX (n = 13) or treatment-as-usual (n = 12) group. Cognitive assessments were administered pre- and postintervention, and quality of life and participation questionnaires 1-month postdischarge. Data analysis included repeated measures analysis of variance mixed design and independent t-tests, extracting effect sizes. Results Significant group-by-time interaction effect with a medium effect size was found for the primary outcome measure; EFs manifested in complex daily activities, indicating a larger improvement for the experimental group. The group effect was not significant. The experimental group’s mean delta score (pre–post improvement) was significantly higher (1.75 ± 2.89; t (23) = 2.52, P = .019), with a large effect size ( d = 1.012, 95% confidence interval [0.166-1.840]). We found no significant group and interaction effects for EFs, self-awareness, and cognitive self-efficacy or no significant differences in participation or quality of life postdischarge. Conclusions Results provide initial evidence for the I-PEX efficacy in treating EFDs in the subacute phase and could help determine effect size for future studies. Clinical Trial Registry Number: ClinicalTrial.gov NCT04292925.