abstract
- Current standards for clinical trials require that behavioral interventions be thoroughly specified, that clinicians be well trained and closely supervised and that performance be carefully monitored to ensure and document treatment fidelity. This article describes procedures developed and implemented for this purpose in the COMBINE Study, a multisite trial combining medications and behavioral interventions for alcohol dependence.Two behavioral treatments were tested in COMBINE: a Medical Management (MM) protocol to accompany the delivery of trial medications and a Combined Behavioral Intervention (CBI) designed as a comprehensive and flexible evidence-based psychotherapy.Information is provided concerning (1) screening and qualifications of practitioners, (2) training and certification in the interventions, (3) on-site supervision and coordination of the two treatments, (4) central monitoring and coding of treatment sessions and (5) maintenance and documentation of treatment fidelity.Both interventions were delivered with fidelity. Problems encountered and important choices made in the implementation of training and quality assurance for CBI and MM are briefly described.