OBJECTIVE: This article argues that nondrinking outcomes are essential to include in complex trials such as COMBINE to assess the hypothesized mechanisms of action and behavioral change associated with both medications and psychotherapy. Toward this end, COMBINE is used as a case study for (1) discussing hypothesized mechanisms of action for behavior change, (2) discussing distinctive design features of combined studies, (3) highlighting issues in the selection of outcome measures, (4) providing a framework for organizing outcome domains and measures and (5) providing a dose-response model for assessing alcoholism treatment outcomes. METHOD: A review of the literature and discussion of methodological issues in assessing nondrinking outcomes is provided as well as a case study in developing a conceptual framework for selecting outcome measures. RESULTS: The results of the review and case study include the development of a framework for categorizing outcome dimensions and measures into condition-specific clinical status, condition-specific symptoms and personal and interpersonal functioning outcomes. In addition, a model is provided for assessing the dose-response of combined alcoholism treatment with multiple dimensions of outcome during and after treatment. CONCLUSIONS: Consistent with previous observations that recovery from alcohol dependence is a multidimensional developmental process, the COMBINE Study will examine the effects of different combinations of pharmacotherapy and behavioral interventions on the magnitude and pattern of changes in various outcome dimensions (both drinking and nondrinking) over time.
OBJECTIVE: This article argues that nondrinking outcomes are essential to include in complex trials such as COMBINE to assess the hypothesized mechanisms of action and behavioral change associated with both medications and psychotherapy. Toward this end, COMBINE is used as a case study for (1) discussing hypothesized mechanisms of action for behavior change, (2) discussing distinctive design features of combined studies, (3) highlighting issues in the selection of outcome measures, (4) providing a framework for organizing outcome domains and measures and (5) providing a dose-response model for assessing alcoholism treatment outcomes. METHOD: A review of the literature and discussion of methodological issues in assessing nondrinking outcomes is provided as well as a case study in developing a conceptual framework for selecting outcome measures. RESULTS: The results of the review and case study include the development of a framework for categorizing outcome dimensions and measures into condition-specific clinical status, condition-specific symptoms and personal and interpersonal functioning outcomes. In addition, a model is provided for assessing the dose-response of combined alcoholism treatment with multiple dimensions of outcome during and after treatment. CONCLUSIONS: Consistent with previous observations that recovery from alcohol dependence is a multidimensional developmental process, the COMBINE Study will examine the effects of different combinations of pharmacotherapy and behavioral interventions on the magnitude and pattern of changes in various outcome dimensions (both drinking and nondrinking) over time.
Authors: Ralitza Gueorguieva; Ran Wu; Dennis Donovan; Bruce James Rounsaville; David Couper; John Harrison Krystal; Stephanie Samples O'Malley Journal: Alcohol Date: 2011-09-17 Impact factor: 2.405
Authors: Rocco Luigi Picci; Francesco Oliva; Marco Zuffranieri; Paola Vizzuso; Luca Ostacoli; Alessandro Jaretti Sodano; Pier Maria Furlan Journal: Qual Life Res Date: 2014-06-15 Impact factor: 4.147
Authors: Katie Witkiewitz; John W Finney; Alex H S Harris; Daniel R Kivlahan; Henry R Kranzler Journal: Alcohol Clin Exp Res Date: 2015-08-06 Impact factor: 3.455
Authors: Joseph S LoCastro; Marston Youngblood; Ron A Cisler; Margaret E Mattson; Allen Zweben; Raymond F Anton; Dennis M Donovan Journal: J Stud Alcohol Drugs Date: 2009-03 Impact factor: 2.582
Authors: Meenakshi Sabina Subbaraman; Samuel Lendle; Mark van der Laan; Lee Ann Kaskutas; Jennifer Ahern Journal: Addiction Date: 2013-06-04 Impact factor: 6.526
Authors: Shannon Gwin Mitchell; Jan Gryczynski; Robert P Schwartz; C Patrick Myers; Kevin E O'Grady; Yngvild K Olsen; Jerome H Jaffe Journal: J Psychoactive Drugs Date: 2015 Apr-Jun