Abstract
While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.
Highlights
While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, cognitive-behavioral therapy trials, cannot be double-blinded
The conclusions of the rationale presented in this paper would be that for major depressive disorder (MDD): 1. Pill placebos show considerable positive effect on disorders with subjective endpoints such as those used to rate MDD5–7
It is imperative that any intervention for a disorder with subjective endpoints such as MDD requires the same rigor in double-blinding in order to conclude that the results show “efficacy” or are “evidence-based”
Summary
The conclusions of the rationale presented in this paper would be that for MDD: 1. Pill placebos show considerable positive effect on disorders with subjective endpoints such as those used to rate MDD5–7. 3. Psychotherapy clinical trials are non-blinded studies, and cannot effectively be double-blinded. 4. It is imperative that any intervention for a disorder with subjective endpoints such as MDD requires the same rigor in double-blinding in order to conclude that the results show “efficacy” or are “evidence-based”. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. We hope this paper can stimulate more research related to problems in blinding of psychotherapy outcome studies, the potential economic and clinical costs of providing or not-providing private or national health reimbursement for psychotherapeutic interventions, and further discussion on how our official professional organizations and national research centers will define “evidence-based” in relation to interventions for major depressive disorder. Grant information The author(s) declared that no grants were involved in supporting this work
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