The role of the communicated treatment rationale on treatment outcome: study protocol for a randomized controlled trial

Trials

Study Protocol

Winfried Rief¹  Liv Henrich¹  Marcel Wilhelm¹  Philipp Lange¹ 

[1] Department of Psychology, Division of Clinical Psychology and Psychotherapy, Philipps University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany;

关键词: Depression;    Treatment expectations;    Pharmacological placebo;    Psychological placebo;    Treatment rationale;    Adults;   

DOI  :  10.1186/s13063-023-07557-w

 received in 2023-06-08, accepted in 2023-07-30,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundPlacebo effects are a well-established phenomenon in the treatment of depression. However, the mechanism underlying these effects are not fully understood. Treatment expectations are considered one explanation for why placebos work. Treatment expectations are likely to be affected by clinician-patient interactions. This study aims to investigate the role of the communicated treatment rationale in modulating treatment expectations and its effects on the treatment outcomes of a pharmacological and a psychological active placebo intervention for depression. In this study, treatment expectations are modulated by presenting illness models that are either congruent or incongruent with the treatment intervention that follows.MethodsThis 2 × 2 randomized controlled trial will involve patients with major depression. Participants will either receive a biological or a psychological illness model from a clinician. Following this, they are randomly assigned to receive either a pharmacological or a psychological active placebo intervention. The illness model and the treatment are either congruent or incongruent with each other, resulting in four groups. In addition, a natural course control group will be included.DiscussionThis study will provide insights into the mechanism of expectation modulation in active placebo treatments for major depression. The results may provide insights for clinicians to improve their communication with patients by focusing on treatment expectations. By identifying the factors that contribute to placebo effects, this study has the potential to improve the effectiveness of existing depression treatments and reduce the burden of this highly prevalent mental health condition.Trial registrationThis trial has been registered prospectively at ClinicalTrials.gov under the identifier: NCT04719663. Registered on January 22, 2021.

【 授权许可】

CC BY   
© BioMed Central Ltd., part of Springer Nature 2023

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