Toby Dresdner, MA
Doctoral Student
Ferkauf Graduate School of Psychology
It is widely accepted that behavioral health interventions are generally safe and low-risk, especially in comparison to pharmaceuticals, but it is not the case that they never produce harm.
Consider running, an activity almost universally hailed as a health-promoting behavior. This does not mean, however, that it never stresses patients’ knees or is a tolerable activity for everyone. Running, especially for beginners, can be uncomfortable and challenging, experiences which some may argue qualify as adverse events.
This is not to say that running, generally speaking, is unhealthy or harmful!
Behavioral health providers may need to rethink the idea that identifying and reporting potential adverse events in behavioral health interventions threatens the legitimacy of these practices. When we minimize the discomforts, potential harms, and issues with tolerability, we do a major to patients. At the lowest level, we risk alienating patients who are confused as to why this “healthy activity” is so unpleasant. In extreme circumstances, we become part of a greater system that pressures patients to adhere to a so-called “health behavior,” despite signals coming from their body that they are damaging their tendons.
Peterson and colleagues (2013) argued that behavioral health clinical trials need to more thoroughly measure and report adverse events so that investigators can 1) conduct studies in line with good clinical practice and 2) patients can make informed decisions about engaging in treatments. Once researchers are committed to measuring and reporting these events, the difficulty lies in defining adverse events in behavioral health interventions.
In order to capture this information about adverse event rates and who is most vulnerable, we need researchers to adopt a systematic way of measuring and reporting adverse events in their trials. Without a consensus on the definition of what constitutes an adverse event, trials may report misleadingly different event rates. Until a consensus is reached, published adverse event rates for behavioral health interventions are limited in how much information they communicate.
Many researchers only report serious adverse events, such as hospitalizations related to the treatment—rare events in behavioral health interventions. The effect of this publication strategy suppresses the more common harms that take place. The U.S. Food and Drug Administration [FDA] (2023) defines events as “any undesirable experience associated with the use of a medical product in a patient.” By definition, if an adverse event is “any undesirable experience,” it could be argued that a sunburn someone gets while running outside or the insecurity someone feels because they notice their limited endurance could constitute adverse events. The risk of defining an adverse event in this way swings too much to the other end of the pendulum, whereby the potential message to patients is that healthy activities are very risky.
Another aspect to contemplate is whether events related to the direct mechanism of action should be considered an adverse event, which has been an ongoing debate in the mindfulness literature (Baer et al., 2019). Studies have shown that mindfulness-based interventions commonly increase perceptions of physical discomfort, such as increased physical tension, localized body pain, and gastrointestinal problems, though it is currently unclear how distressing these experiences are for participants (Britton et al., 2021; Farias et al., 2020). While it seems unlikely that mindfulness causes more pain—in fact, mindfulness may have an analgesic effect (Wells et al., 2014)—it does encourage people to pay more attention to their bodily sensations, which may result in increased awareness of pain that already exists. If interoception, or the capacity to notice internal bodily sensations, is a direct result of mindfulness (Britton, 2019), is it fair to categorize the heightened awareness of bodily pain as an adverse event? If an activity challenges one’s tolerability of it, but is an expected or common byproduct of progressing in the activity, does that also count as an adverse event?
Defining adverse events in behavioral health interventions is inherently fraught and complicated. Currently, because of limited guidelines, providers are left to use their clinical judgment to determine whether something constitutes an adverse event. While one provider would never consider feeling insecure during running to be an adverse event, another with a different definition of “undesirable” may consider it otherwise. To reconcile these complications, the field of health psychology needs a panel of providers and research investigators to come up with clear guidelines, a critical step towards adhering to good clinical practice.
References
Baer, R., Crane, C., Miller, E., & Kuyken, W. (2019). Doing no harm in mindfulness-based programs: Conceptual issues and empirical findings. Clinical Psychology Review, 71, 101-114. https://doi.org/https://doi.org/10.1016/j.cpr.2019.01.001
Britton, W. B. (2019). Can mindfulness be too much of a good thing? The value of a middle way. Current Opinion in Psychology, 28, 159-165. https://doi.org/10.1016/j.copsyc.2018.12.011
Britton, W. B., Lindahl, J. R., Cooper, D. J., Canby, N. K., & Palitsky, R. (2021). Defining and measuring meditation-related adverse effects in mindfulness-based programs. Clinical Psychological Science, 9(6), 1185-1204. https://doi.org/10.1177/2167702621996340
Farias, M., Maraldi, E., Wallenkampf, K. C., & Lucchetti, G. (2020). Adverse events in meditation practices and meditation-based therapies: A systematic review. Acta Psychiatrica Scandinavica, 142(5), 374-393. https://doi.org/10.1111/acps.13225
Peterson, A. L., Roache, J. D., Raj, J., & Young-McCaughan, S. (2013). The need for expanded monitoring of adverse events in behavioral health clinical trials. Contemporary Clinical Trials, 34(1), 152-154. https://doi.org/10.1016/j.cct.2012.10.009
U.S. Food and Drug Administration. (2023, May 18). What is a serious adverse event? https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event
Wells, R. E., Burch, R., Paulsen, R. H., Wayne, P. M., Houle, T. T., & Loder, E. (2014). Meditation for migraines: A pilot randomized controlled trial. Headache: The Journal of Head and Face Pain, 54(9), 1484-1495. https://doi.org/https://doi.org/10.1111/head.12420