title: Manual-guided psychosocial treatment. A new virtual requirement for pharmacotherapy trials?
abstract: The conduct of randomized clinical trials to evaluate the efficacy of pharmacotherapies for mental disorders is guided by research standards (at a high level of rigor) that govern most design elements, including randomization of subjects, use of placebo controls, formulation and dosage of the therapeutic agent, and monitoring of serum levels. In contrast, no such widely accepted guidelines are recognized for standardization of an essential, if unacknowledged, element of all such studies: the concomitant provision of at least a minimal form of psychosocial treatment. Standardized provision of psychosocial treatments in pharmacotherapy trials will foster replicability of findings and address several common problems (e.g., attrition, medication noncompliance, reduction of error variance, and ethical issues associated with placebo controls). Careful selection and standardization of the psychosocial context in which medications are delivered will improve the validity, precision, and power of pharmacotherapy efficacy research, and should be considered a virtual requirement in research design.
authors.affiliation: Division of Substance Abuse, Yale University School of Medicine, New Haven, Conn., USA.
authors.forename: K M
authors.initials: KM
authors.lastname: Carroll
mesh_terms: D002985:Clinical Protocols; D003131:Combined Modality Therapy; D003365:Costs and Cost Analysis; D004992:Ethics, Medical; D006801:Humans; D008370:Manuals as Topic; D001523:Mental Disorders / Q000188:drug therapy* / Q000523:psychology / Q000628:therapy; D010349:Patient Compliance; D018579:Patient Selection; D010919:Placebos; D011613:Psychotherapy; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods / Q000592:standards*; D012107:Research Design / Q000592:standards*; D012944:Social Support
chemical_list: D010919:Placebos