CLINICAL-TRIALS OF PRIMARY-CARE TREATMENTS FOR MAJOR DEPRESSION - ISSUES IN DESIGN, RECRUITMENT AND TREATMENT

The objective of this article is to consider whether randomized clinic al trials (RCTs) are able to determine the validity of transferring tr eatments for major depression from the psychiatric to the primary care sector. This clinical issue is of growing concern in the United State s since both governmental and professional bodies are establishing gui delines for the treatment of medical patients with the affective disor der. The article's method involves analysis of how the competing aims of rigorous scientific methodology (internal validity) and generalizat ion of study findings (external validity) are best balanced within the RCT. Experiences in recruiting medical patients with major depression and providing pharmacologic, psychotherapeutic, and usual care interv entions compatible with the sociotechnical characteristics of ambulato ry medical centers are described to illustrate the complexities of inv estigating transferability of treatments for major depression with RCT methodology.