Training, supervision and quality monitoring of the COMBINE Study behavioral interventions

Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque, New Mexico 87131-0001, USA.
Journal of studies on alcohol. Supplement 08/2005; 15(15):188-95; discussion 168-9. DOI: 10.15288/jsas.2005.s15.188
Source: PubMed


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.

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Available from: Theresa B Moyers, Jan 08, 2015
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    ABSTRACT: The primary goals in conducting clinical trials of treatments for alcohol use disorders (AUDs) are to identify efficacious treatments and determine which treatments are most efficacious for which patients. Accurate reporting of study design features and results is imperative to enable readers of research reports to evaluate to what extent a study has achieved these goals. Guidance on quality of clinical trial reporting has evolved substantially over the past 2 decades, primarily through the publication and widespread adoption of the Consolidated Standards of Reporting Trials statement. However, there is room to improve the adoption of those standards in reporting the design and findings of treatment trials for AUD. This paper provides a narrative review of guidance on reporting quality in AUD treatment trials. Despite improvements in the reporting of results of treatment trials for AUD over the past 2 decades, many published reports provide insufficient information on design or methods. The reporting of alcohol treatment trial design, analysis, and results requires improvement in 4 primary areas: (i) trial registration, (ii) procedures for recruitment and retention, (iii) procedures for randomization and intervention design considerations, and (iv) statistical methods used to assess treatment efficacy. Improvements in these areas and the adoption of reporting standards by authors, reviewers, and editors are critical to an accurate assessment of the reliability and validity of treatment effects. Continued developments in this area are needed to move AUD treatment research forward via systematic reviews and meta-analyses that maximize the utility of completed studies. Copyright © 2015 by the Research Society on Alcoholism.
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