Informing About the Nocebo Effect Affects Patients' Need for Information About Antidepressants-An Experimental Online Study

Yvonne Nestoriuc, Yiqi Pan, Timm Kinitz, Ella Weik, Meike C Shedden-Mora, Yvonne Nestoriuc, Yiqi Pan, Timm Kinitz, Ella Weik, Meike C Shedden-Mora

Abstract

Relevance: Understanding patients' informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects. Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients' need for information about antidepressants. Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs. Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [ X ( 4 , 97 ) 2 = 12.714, Cramer's V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [ X ( 4 , 97 ) 2 = 14.878, Cramer's V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151). Conclusions: Learning about the nocebo effect can alter patients' informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

Keywords: adverse (side) effects; antidepressants; ethics; expectation; informed consent; nocebo effects; shared decision making.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Nestoriuc, Pan, Kinitz, Weik and Shedden-Mora.

Figures

Figure 1
Figure 1
Illustration of nocebo effects in everyday life. ©Timm Kinitz.
Figure 2
Figure 2
Satisfaction with information about medication at prescription. Percentages indicate the proportion of patients agreeing to each item (scores #3–5) (N = 97).
Figure 3
Figure 3
Preferred information disclosure about side effects. Black marked columns indicate the percentage of participants who wish to receive detailed information about the potential side effects. (A) Would you find it beneficial if your practitioner did not inform you about all possible side effects? (B) How thoroughly would you like your practitioner to inform you about possible side-effects? (C) Which side would you like to be informed about.
Figure 4
Figure 4
Wish for disclosure about modes of action of the antidepressant by the intervention group. Student’s t-tests for independent samples were conducted. Each scale ranges from 1 “do not agree at all” to 5 “fully agree”; bars indicate means. AD, antidepressant, *p < 0.05, **p < 0.01.

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