Mental Health: A Report by the Surgeon General

Mental health professionals have long observed that treatments work better in the clinical research trial setting as opposed to typical clinical practice settings. The diminished level of treatment effectiveness in real-world settings is so perceptible that it even has a name, the “efficacy-effectiveness gap.” Efficacy is the term for what works in the clinical trial setting, and effectiveness is the term for what works in typical clinical practice settings. The efficacy-effectiveness gap applies to both pharmacological therapies and to psychotherapies (Munoz et al., 1994; Seligman, 1995). The gap is not unique to mental health, for it is found with somatic disorders too.

The magnitude of the gap can be surprisingly high. With schizophrenia medications, one review article found that, in clinical trials, the use of traditional antipsychotic medications for schizophrenia was associated with an average annual relapse rate of about 23 percent, whereas the same medications used in clinical practice carried a relapse rate of about 50 percent (Dixon et al., 1995). The magnitude of the gap found in this study may not apply to other medications and other disorders, much less to psychological therapies. Studies of real-world effectiveness are scarce. Yet some degree of gap is widely recognized. The question is, why?

Efficacy studies test whether treatment works under ideal circumstances. They typically exclude patients with other mental or somatic disorders. In the past, they typically have examined relatively homogeneous populations, usually white males. Furthermore, efficacy studies are carried out by highly trained specialists following strict protocols that require frequent patient monitoring. Finally, participation in efficacy studies is often free of charge to patients.

It is not surprising that the reasons commonly cited to explain the discrepancy between efficacy and effectiveness focus on the practicalities and constraints imposed by the real world. In real-world settings, patients often are more heterogeneous and ethnically diverse, are beset by comorbidity (more than one mental or somatic disorder),18 are often less compliant, and are seen more often in general medical rather than specialty settings; providers are less inclined to adequately monitor and standardize treatment; and cost pressures exist on both patients and providers, depending on the nature of the financing of care (Dixon et al., 1995; Wells & Sturm, 1996). This constellation of real-world constraints appears to explain the gap.

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