Hc. Schulberg et al., CLINICAL-TRIALS OF PRIMARY-CARE TREATMENTS FOR MAJOR DEPRESSION - ISSUES IN DESIGN, RECRUITMENT AND TREATMENT, International journal of psychiatry in medicine, 23(1), 1993, pp. 29-42
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.