Abstract
BACKGROUND: Evidence-based approaches to cognitive rehabilitation are limited; however, new technologies such as brain-training computer programs provide opportunities for novel interventions.
OBJECTIVE: This paper describes a randomized controlled training study in a military treatment facility with service members who had combat-related cognitive symptoms. It examines challenges in study design and implementation, and provides "lessons learned" with proposed solutions.
METHODS: Participants were randomly assigned to one of two 6-week computer-based cognitive training (CBCT) programs or a treatment-as-usual (TAU) control group. Feasibility assessments included reasons for consent refusal, compliance, and drop-out rates.
RESULTS: The intended sample size for the study was 114 participants before attrition. Of 291 patients referred over 2.5 years, 120 were eligible, 38 consented to participate, and 18 completed the study. Forty-two percent of the participants assigned to CBCT groups completed the required 30 sessions in 6.5 to 32 weeks. Study-design factors that affected enrollment and compliance included eligibility restrictions, lack of a computer-based control condition, and inflexible scheduling.
CONCLUSIONS: Successful implementation of a high-dose computer-based clinical trial will require design changes such as expanded inclusion criteria, control by sham computer program or wait-list, dosing flexibility, and web-based options.