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Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study

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Abstract

Purpose

Informing patients about treatment side effects increases the occurrence and intensity of side effects. Since the obligatory informed consent procedure in drug treatments requires transparency and nocebo research suggests that the informed consent of a drug leads to an increased occurrence of the mentioned side effects, the aim of this proof of concept study was to determine the effect of two different framings of informed consent on the occurrence, intensity, and perceived threat of side effects.

Methods

Healthy male participants (n = 80) were randomized to one of two framing groups. The positive framing group was informed that the common side effect dizziness was a sign that the drug had started to work, while the neutral framing group was told that dizziness is an unpleasant but well-known side effect. Side effects were measured after the administration of metoprolol, an antihypertensive agent. Post hoc moderator analyses investigated the effect of pre-existing negative beliefs about the general harm of medication on the framing manipulation.

Results

Metoprolol-specific drug-attributed side effects were rated significantly less threatening in the positive framing group. The between-group effect size (Cohen’s d) was small (d = 0.38, p = 0.049). Exploratory post hoc moderator analyses suggest that participants who believed that medication is a source of harmful effects benefited from positive framing, compared to neutral framing of drug-attributed side effects.

Conclusions

Positive framing was partially effective in decreasing specific side effect measures, particularly among participants with a tendency to believe that medicine is harmful. Informed consent procedures should therefore be personalized, focusing on patients with negative treatment beliefs.

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Acknowledgements

The authors would like to thank G. Schürmann for the medical assessment of the participants and A. Schmitt, E. Helmig, and M. Reinwald for their help in data acquisition.

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Authors and Affiliations

  1. Department of Clinical Psychology and Psychotherapy, University of Marburg, Gutenbergstraße 18, 35032, Marburg, Germany

    Marcel Wilhelm & Winfried Rief

  2. Department of Clinical and Biological Psychology, Catholic University Eichstätt-Ingolstadt, Eichstätt, Germany

    Bettina K. Doering

Authors
  1. Marcel Wilhelm
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  2. Winfried Rief
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  3. Bettina K. Doering
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Corresponding author

Correspondence to Marcel Wilhelm.

Ethics declarations

All procedures performed involving human participants were in accordance with the ethical standards of the ethics committee of the Medical Chamber Hessen which approved the study and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of Interest

The authors declare that they have no conflict of interest.

Informed Consent

Informed consent was obtained from all participants included in the study.

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Wilhelm, M., Rief, W. & Doering, B.K. Decreasing the Burden of Side Effects Through Positive Message Framing: an Experimental Proof-of-Concept Study. Int.J. Behav. Med. 25, 381–389 (2018). https://doi.org/10.1007/s12529-018-9726-z

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  • DOI: https://doi.org/10.1007/s12529-018-9726-z

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