Choosing a control group in effectiveness trials of behavioral drug abuse treatments

Maryhaven Research Institute, Maryhaven, Columbus, OH 43207, USA.
Journal of substance abuse treatment (Impact Factor: 2.9). 07/2009; 37(4):388-97. DOI: 10.1016/j.jsat.2009.05.004
Source: PubMed


Effectiveness trials are an important step in the scientific process of developing and evaluating behavioral treatments. The focus on effectiveness research presents a different set of requirements on the research design when compared with efficacy studies. The choice of a control condition has many implications for a clinical trial's internal and external validity. The purpose of this article was to provide a discussion of the issues involved in choosing a control group for effectiveness trials of behavioral interventions in substance abuse treatment. The authors provide a description of four trial designs and a discussion of the advantages and disadvantages of each.

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Available from: Daniel J Feaster,
    • "For nonpharmacological interventions, the CONSORT checklist includes additional recommendations for reporting the specific details of the experimental and comparator conditions , including a description of the components of the interventions and any tailoring of the interventions to individual participants, details regarding standardization of the interventions and adherence to the intervention protocols, and how adherence to intervention protocols was assessed. All of these recommendations can be particularly important in alcohol treatment trials in which " treatment as usual " or " standard care " interventions are included as comparison interventions (Brigham et al., 2009), as these approaches may vary substantially across studies. This information is crucial to allow the relative effects of different interventions to be assessed in research syntheses. "
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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.
    Alcoholism Clinical and Experimental Research 08/2015; 39(9). DOI:10.1111/acer.12797 · 3.21 Impact Factor
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    • "Note that Design 2 in the original conceptualization (Brigham, Feaster, Wakim, and Dempsey, 2009) has been subdivided into Design 2a and Design 2b, depending on whether the new intervention is an add-on to TAU, or substitutes for some existing component of TAU. "
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    ABSTRACT: Multisite effectiveness trials such as those carried out in the National Drug Abuse Treatment Clinical Trials Network (CTN) are a critical step in the development and dissemination of evidence-based treatments because they address how such treatments perform in real-world clinical settings. As Brigham et al. summarized in a recent article (G. S. Brigham, D. J. Feaster, P. G. Wakim, & C. L. Dempsey C. L., 2009), several possible experimental designs may be chosen for such effectiveness trials. These include (a) a new treatment intervention (Tx) is compared to an existing mode of community based treatment as usual (TAU): Tx versus TAU; (b) a new intervention is added to TAU and compared to TAU alone: Tx + TAU versus TAU; or (c) a new intervention is added to TAU and compared to a control condition added to TAU: Tx + TAU versus control + TAU. Each of these designs addresses a different question and has different potential strengths and weaknesses. As of December 2009, the primary outcome paper had been published for 16 of the multisite randomized clinical trials conducted in the CTN, testing various treatments for drug abuse, HIV risk behavior, or related problems. This paper systematically examines, for each of the completed trials, the experimental design type chosen and its original rationale, the main findings of the trial, and the strengths and weaknesses of the design in hindsight. Based on this review, recommendations are generated to inform the design of future effectiveness trials on treatments for substance abuse, HIV risk, and other behavioral health problems.
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    ABSTRACT: Many depressed women seen in community mental health centers (CMHCs) have histories of childhood sexual abuse and are economically disadvantaged. Randomized trials are needed to test the effectiveness of evidence-based interventions in this population and setting. This study compared interpersonal psychotherapy with usual care psychotherapy among women in a CMHC. Among 1,100 women seeking treatment in a CMHC, 230 (21%) had major depression and histories of childhood sexual abuse. Seventy women with major depression and sexual abuse before age 18 were randomly assigned to interpersonal psychotherapy (N=37) or usual care psychotherapy (N=33). Staff clinicians provided all treatments. Participants were assessed at study entry and at ten, 24, and 36 weeks after random assignment. Generalized estimating equations were used to examine change over time. Compared with women assigned to usual care, women who received interpersonal psychotherapy had greater reductions in depressive symptoms (Hamilton Rating Scale, p=.05, d=.34; Beck Depression Inventory-II, p=.01, d=.29), posttraumatic stress disorder symptoms (p=.04, d=.76), and shame (p=.002, d=.38). Interpersonal psychotherapy and usual care yielded comparable improvements in social and mental health-related functioning. Interpersonal psychotherapy compared favorably to usual care psychotherapy in a CMHC in improving psychiatric symptoms and reducing shame among sexually abused women. However, there is a critical need for continued research to develop more effective treatments for the social and psychiatric sequelae of interpersonal trauma and socioeconomic disadvantage.
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