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A Psychotherapeutic Context for Clinical Trials Is Promising, But Manualization Is Not

Donald F. Klein, MD; Lauren B. Smith
Arch Gen Psychiatry. 1997;54(10):929-930. doi:10.1001/archpsyc.1997.01830220051008.
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IN THIS issue of the ARCHIVES, Carroll1 argues for a psychotherapeutic context, standardized by manualization, for pharmacotherapy trials. This may well succeed in lowering the attrition rate and improving compliance,2 but the superiority of detailed manuals over goal-oriented, supportive therapy has not been demonstrated. Therefore, standardization by manuals is premature.

THE ADOPTION OF MANUALS  Manual-based psychotherapy has become standard in psychotherapy research, to provide a distinct, operationalized, replicable structure. In comparative psychotherapy trials, manuals ensure adequate differentiation between therapies, thus allowing strong statements as to what was actually done.3,4 However, since it has not been shown that manuals increase the treatment efficacy or diminish outcome variance, their required use See also page 923 compared with manual-free, supportive psychotherapy has not been shown to be necessary. Such a manual requirement may expensively address a nonexistent problem.

RESEARCH ON THE EFFICACY OF MANUALS  Schulte et al5 compared the


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