Preventing hung juries about therapy studies.

Abstract

A series of arguments are presented that emphasize the importance of comparatively evaluating psychotherapies with appropriate pharmacotherapy and pill placebo. The lack of a pill-placebo arm has rendered moot those studies that compared pharmacotherapy directly with psychotherapy because of the lack of an internal sample defining calibration with regard to medication responsivity. The National Institute of Mental Health (NIMH) Treatment of Depression Collaborative Research Program is critically discussed because this program incorporated the recommended design features but still led to substantial controversy. The inclusion of a pill-placebo arm in future therapeutic studies is most desirable. NIMH should initiate a funded program specifically for multisite, pill-placebocontrolled studies of psychotherapy, pharmacotherapy, and their combination, jointly sponsored and supervised by skilled psychopharmacologists and psychotherapists.

Defining empirically supported therapies.

“…In most naturalistic follow-ups, patients not only must complete treatment but must show improvement to be retained in the sample. If one treatment is more effective than another in keeping high-risk patients in treatment or in eliciting their response, then acute treatment can act as a differential sieve that undermines the effects of initial randomization ( Klein, 1996 ). For example, several studies have suggested that patients treated to remission with cognitive therapy are about half as likely to relapse after treatment termination as patients who respond to pharmacotherapy ( Hollon et al, 1991 ).…”

“…Although this design allows the investigator to avoid assigning some clients to conditions he or she believes will be inferior, the resultant data are inherently difficult to interpret. One concern is that the evaluator needs to be confident that the established comparison treatment was implemented well in the particular study; otherwise, the unproven treatment will erroneously be deemed efficacious by comparison with a degraded version of the more established treatment ( Klein, 1996 ). Another common problem is low statistical power.…”

“…Concomitantly, low-risk patients would be systematically screened out of pharmacotherapy because they could not tolerate the medication. The consequence would be that underlying risk would no longer be randomly distributed between the treatment conditions, and cognitive therapy's apparent prophylactic effect could be nothing more than an artifact of its lower capacity to retain high-risk patients ( Klein, 1996 ).…”

Viejas y nuevas cuestiones en las viejas y nuevas terapias psicológicas

“…Así, Klein (1996) concluyó que la imipramina tuvo efectos más beneficiosos en pacientes con depresión más grave, mientras que Jacobson y Hollon (1996) señala-ron que los pacientes tratados con imipramina abandonaron con mayor frecuencia el tratamiento y presentaron más recaídas y, por otra parte, estos últimos autores señalaron que todos los trabajos publicados han encontrado una superioridad de la terapia cognitiva frente a los fármacos en el tratamiento de la depresión. A todo ello hay que añadir la carencia de información respecto a las interacciones multivariable que se presentan en el análisis de casos reales y complejos como son las depresiones.…”

Understanding prognostic benefits of exercise and antidepressant therapy for persons with depression and heart disease: the UPBEAT study — rationale, design, and methodological issues

“…This variability greatly limited our freedom to make assumptions about the placebo response rate in any new study context. It is for this reason that Klein [77] concluded that any investigation comparing psychosocial interventions to an established antidepressant medication (representing the 'standard of care') must include a pill-placebo condition in order to assure that the patient sample is actually one that is responsive to the medication beyond the effects of a placebo. Unless a superiority of medication to pill-placebo can be demonstrated in the current study, it could be maintained that these patients were not medication-responsive and that any observed treatment effects would be open to parsimonious explanation as a placebo response.…”