A qualitative study of key stakeholders’ perceived risks and benefits of psychiatric electroceutical interventions

Abstract

Amid a renewed interest in alternatives to psychotherapy and medication to treat depression, there is limited data as to how different stakeholders perceive of the risks and benefits of psychiatric electroceutical interventions (PEIs), including electroconvulsive therapy (ECT) and deep brain stimulation (DBS). To address this gap, we conducted 48 semi-structured interviews, including 16 psychiatrists, 16 persons diagnosed with depression, and 16 members of the general public. To provide a basis of comparison, we asked participants to also compare each modality to front-line therapies for depression and to neurosurgical procedures used for non-psychiatric conditions. Across all stakeholder groups, perceived memory loss was the most frequently mentioned potential risk with ECT. The most discussed benefits across all stakeholder groups were efficacy and quick response. Psychiatrists most often referenced effectiveness when discussing ECT, while patients and the public did so when discussing DBS. Taken as a whole, these data highlight stakeholders’ contrasting perspectives on the risks and benefits of electroceuticals.

Introduction

Recent decades have seen a renewed interest in developing novel alternatives to psychotherapy and medication to treat depression (Pandurangi, Fernicola-Bledowski, and Bledowski 2012), especially psychiatric electroceutical interventions (PEIs), which administer an electrical current to the brain to elicit a therapeutic effect (Famm et al. 2013; Reardon 2014; Strickland 2016). Some PEIs, such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS), are already approved therapies with evidence supporting their effectiveness for reducing depressive symptoms in some patients (McClintock et al. 2018; George et al. 2010). Others, such as deep brain stimulation (DBS) and adaptive brain implants (ABIs), are still under clinical investigation, and their safety and effectiveness when used for patients with treatment refractory depression remains to be determined (Lozano et al. 2008; Lozano et al. 2019). In this article, we aim to examine the perceived risks and benefits about these four electroceuticals across three stakeholder groups. Our goal is to identify shared risk and benefits perceptions across stakeholder groups and interventions, as well as those that might be unique to a particular stakeholder group or intervention by using semi-structured interviews with psychiatrists, persons diagnosed with depression, and members of the general public. This study is part of a larger project investigating key stakeholders’ views about using four electroceuticals for treatment resistant depression (TRD): ECT, rTMS, DBS, and ABIs.

Clinical Evidence on Risk and Benefits of Selected PEIs for Depression

The efficacy of ECT in the treatment of major depression is well-established (Pagnin et al. 2004; Kho et al. 2003), with the United States Food and Drug Administration (FDA) recently reclassifying ECT devices to a less restrictive category for treating major depression and catatonia (Department of Health and Services 2016). Patients who respond to ECT often achieve depressive symptom relief or remission in as few as six to ten treatment sessions (Husain et al. 2004). Yet, ECT remains a controversial intervention because of its potential negative effects on memory and cognition (Robertson and Pryor 2006) and negative portrayals of the treatment in film and television (Walter et al. 2002; Walter 2004; Griffiths and O’Neill-Kerr 2019).

Though rTMS has a shorter history of clinical use than ECT, over 25 years of data support its efficacy and safety for depressive disorder (George et al. 1995; Berman et al. 2000; Slotema et al. 2010; Chen et al. 2017). Common side effects include transient head or scalp discomfort and headaches (McClintock et al. 2018), and an induced seizure, which is uncommon (<0.1% frequency), is understood as the biggest risk with rTMS (Dobek et al. 2015).

DBS is an established, FDA-approved brain implant therapy for some movement disorders, including essential tremor, Parkinson’s disease, and dystonia; however, it is still experimental for most psychiatric conditions, including depression (Harmsen et al. 2020). While there is some early, limited evidence that DBS may offer depressive symptom relief (Mayberg et al. 2005; Dougherty et al. 2015; Lozano et al. 2008; Morishita et al. 2014), its efficacy and safety as a treatment for depression is far from conclusive. In comparison to ablative procedures, commonly mentioned benefits of DBS are its adjustability and reversibility (Müller, Riedmuller, and van Oosterhout 2015). Risks associated with DBS include those related to any major surgical intervention, such as intercranial hemorrhage, skin infection, and, rarely, death (Hariz 2002; Voges et al. 2007), and stimulation-induced adverse effects such as suicidality, hypomania, and visual disturbance (Müller, Riedmuller, and van Oosterhout 2015). Malfunctions with the hardware such as lead fracture and erosion can sometimes occur (Constantoyannis et al. 2005).

ABIs, a form of closed-loop DBS, use a brain-computer interface to record patient brain signals and adapt the flow of electrical current that they deliver to the brain (Ward and Irazoqui 2010; Widge, Malone, and Dougherty 2018). To date these implants have been under investigation only for Parkinson’s disease and epilepsy; though, we might soon start seeing trials for psychiatric disorders (Widge, Malone, and Dougherty 2018). While there is little long-term data on the benefits and risks of this intervention, researchers hypothesize that due to the adaptive nature of these implants they are likely to have an enhanced therapeutic efficacy and a reduced risk profile, compared with open-loop DBS (Ward and Irazoqui 2010; Little et al. 2013; Ramirez-Zamora et al. 2018).

Risk and Benefit Perceptions

Decades of social science research on how technical risk experts (Dietz and Rycroft 1988) and laypeople (Slovic 2000) assess the risks and benefits of various technological, environmental, and public health phenomena demonstrate the necessity not only of acknowledging technical risk assessments, but also of considering how relevant stakeholder groups perceive such risks (Rosa, Renn, and McCright 2014). Risk perceptions—“people’s beliefs, attitudes, judgments, and feelings, as well as the wider social or cultural values and dispositions that people adopt, towards hazards and their benefits” (Pidgeon et al. 1992, 89)—provide important context and nuance to “differing views about the meaning of risk and uncertainty and their acceptance and distribution across society” (Pidgeon 2008, 349).

Technical risk experts tend (at least in their own field of expertise) to define risk narrowly as the probability of an event occurring multiplied by the magnitude of the event’s negative consequences, and to calculate risk quantitatively as number of fatalities or amount of financial costs. Laypeople (and even experts considering phenomena outside of their own field of expertise) tend to view risk more broadly through an array of mental heuristics, cognitive shortcuts, and social frames (Stern and Fineberg 1996; Jaeger et al. 2013). This pattern helps explain an oft-mentioned paradox—that the general public views riding in airplanes as much riskier than riding in automobiles even while experts point out how fatalities and costs from the latter dwarf those of the former every year. Most risk perception research in recent decades demonstrates how and why certain characteristics of risks themselves as well as varied heuristics and frames shape how different individuals and groups within and across societies perceive certain kinds of events or phenomena as more or less risky (Slovic 1987; Covello 1983; Boholm 1998). They point out that risk perceptions are shaped heavily by socio-cultural characteristics such as people’s values, emotions, affect, and perceived trust in risk producers and regulators (Slovic et al. 2004; Slovic 1999)—as well as by societal factors such as media coverage and social networks (Kasperson et al. 1988). This usage of heuristics, trust, intuitions, and other ‘non-rational’ or ‘informal’ approaches to uncertainty are shared by expert-professionals and wider publics (Horlick-Jones, Walls and Kitzinger 2007; Raab and Gigerenzer 2015; Zinn 2008), as these are not only influenced by available knowledge but also “by the ways in which they are embedded in the culture and social relations” (Zinn 2008, 445; See also Horlick-Jones et al 2007).

An improved understanding of perceived risks and benefits of the development and use of PEIs is important for several reasons. First, psychiatrists’ risk perceptions influence their referral behavior; clinicians with higher tolerance for risk and uncertainty are more likely to make patient referrals (Tubbs, Elrod, and Flum 2006; Burton et al. 2017). Psychiatrists’ risk perceptions are also likely to influence the form and content of the risk and benefit information they present to patients (Massin, Nebout, and Ventelou 2018). Second, lower risk sensitivity among patients is associated with more risk-seeking in pursuit of effective treatments (Rasiel, Weinfurt, and Schulman 2016). Third, public risk perceptions are likely to influence the level of support or rejection towards expanded use of PEIs. Fourth, considering that risk perceptions shape the priorities and legislative agendas of regulatory bodies and represent a key part of risk-assessment more generally (Slovic 2000), better understanding PEI risk and benefit perceptions is crucial to informing societal decision-making. In the next section, we briefly review those studies that have examined stakeholders’ PEI risk and benefit perceptions.

Studies of Perceived PEI Risks and Benefits

Most studies in this literature have focused on ECT risks and benefits, with many demonstrating how negative media portrayals (e.g., One Flew Over the Cuckoo’s Nest) led to heightened perceived risks of this electroceutical (see Hughes, Barraclough, and Reeve 1981; Malcolm 1989; Walter 2004; Griffiths and O’Neill-Kerr 2019). Perhaps the most widely perceived risk of ECT within the general public is memory loss (Lauber et al. 2005; McFarquhar and Thompson 2008). More recently, a web-based survey found that the German public sees the intervention as a risky therapy (Wilhelmy et al. 2018).

A small number of studies have examined psychiatrists’ and patients’ perceptions of the risks and benefits of rTMS. For instance, one study of 96 Saudi psychiatrists found that approximately 73% of the sample viewed it as safer than ECT, with approximately 16% of the sample perceiving permanent brain damage as a risk (AlHadi et al. 2017). An Australian study of adolescent patients and their parents found that 75% of the former and 62% of the latter considered the intervention safe; however both groups perceived it as mostly unhelpful (Mayer et al. 2012).

To date, few studies have investigated stakeholders’ perceived risks and benefits of implantable electroceuticals. Two examined how patients with major depressive disorder view DBS (Leykin et al. 2011; Lawrence et al. 2019). In their study of 31 US patients, Leykin and colleagues found that participants had a reasonable grasp of risks and benefits and an overall positive attitude toward the intervention—identifying the surgery itself as the greatest risk (Leykin et al. 2011). In their study of 24 patients, Lawrence and colleagues found that participants expressed concerns about a range of surgical and post-surgical complications (including bleeding in the brain, infection, and brain damage) but also mentioned that DBS may help them “live again,” improve their ability to cope with stress, increase their happiness, and help them achieve greater success in professional and interpersonal relationships (Lawrence et al. 2019). While approximately one-third of patients doubted that the implant would effectively treat their depression, another one-third reported that it was likely to benefit them. Further, two studies have examined clinicians’ perceptions of the risks and benefits of DBS. One study of the use of DBS for obsessive-compulsive disorder found that psychiatrists and psychotherapists primarily were concerned about complications from surgery and anesthesia (Naesström et al. 2017), while Cormier and colleagues (Cormier et al. 2019) found that psychiatrists and residents felt DBS was dangerous when used for major depression.

Methodology

We conducted key informant interviews with 16 psychiatrists, 16 patients with depression, and 16 members of the general public in Michigan between February and May 2019. Key informant interviews are ideal for eliciting in-depth, meaningful information from participants (Miles, Huberman, and Saldaña 2013).

Recruitment and Participants

We used a non-probability sampling design of purposive sampling with quotas to recruit potential participants from these three key stakeholder groups. When scheduling interviews, we planned to achieve quotas on gender and race for all participants. We aimed for at least 20 per cent females and at least one non-white individual in our psychiatrist sample. For each of the patient and public samples, we aimed for a balance of male and females, and at least one African American, one Asian and one Hispanic participant. Further, we selected psychiatrists and patients to ensure a range of electroceutical experiences, and we selected members of the public to ensure variation in experiences of caregiving for a family member or close friend with a psychiatric disorder.

For the psychiatrist sample, we contacted potential participants by email with an invitation to participate in the study. For the patients and members of the public, we distributed information about the study to mental health clinics, depression disease support groups, clinician networks, as well as in public places in mid-Michigan and social media posts. When scheduling each interview, we sent participants a letter that described the study and stated that proceeding with the interview indicated their voluntary agreement to participate. We also sent each participant a two-page document with information about the four interventions. This approach to consent, and indeed the study as a whole, was approved by Michigan State University (MSU) Institutional Review Board (Exempt determination STUDY00001247) whereby the formal recording of written consent was not deemed necessary. Participants were informed prior to the start of the interview about their right to decline to answer any questions, or to decide to stop or withdraw their involvement at any point during the interview.

A team member conducted each semi-structured interview with participants in person, by phone, or by video teleconference. We invited participants to ask questions before the interview began. For both our patient and public groups, we had a slight majority of women compared to men. The patient group was on average slightly older (mean: 46 years old) than the public group (mean: 42 years old in average). Most participants for both groups were White, and most participants had completed at least a bachelor’s degree (Table 1).

Table 1.

Demographic Characteristics of the Three Stakeholder Group Sub-Samples

	Psychiatrists (n=16)	Depressed Patients (n=16)	General Public (n=16)
	n (%)	n (%)	n (%)
Gender
Male	11 (68.75%)	6 (37.5%)	7 (43.75%)
Female	5 (31.25%)	10 (62.5%)	9 (56.25%)
Age
Median	54	48.5	40
Range	34-66	18-65	20-81
Race/Ethnicity
White (not Hispanic)	14 (87.5%)	12 (75%)	9 (56.3%)
Hispanic	0	1 (6.25%)	5 (31.3%)
Non-white	2 (12.5%)	3 (18.8%)	2 (12.5%)
Education
High school		3 (18.8%)	1 (6.3%)
Some college		2 (12.5%)	3 (18.8%)
Bachelor		5 (31.3%)	8 (50%)
Master		5 (31.3%)	3 (18.8%)
Doctoral Degree		1 (6.3%)	1 (6.3%)

Procedures

We conducted the semi-structured interviews with an interview guide (Supplemental file) to ensure consistency, as well as to facilitate exploration of unanticipated issues and in-depth understanding, while covering a core set of topics (Miles, Huberman, and Saldaña 2013). A team member (LC, RB, or MP) recorded, and anonymized each interview, which was then transcribed verbatim. We first asked participants some general questions about their experience with and attitudes toward the four electroceuticals. Due to time constraints, we focused the rest of each interview on a number of detailed questions about only one or two of the PEIs. We selected the specific electroceutical(s) for each participant based on their experience and interest. In this article we present our findings about perceived risks and benefits. We asked each participant to compare the risks of a specific intervention to those of front-line therapies for depression (psychotherapy and antidepressant medication) and to those of neurosurgical procedures used for non-psychiatric conditions (DBS for movement disorders, for example).

Data Analysis

We analyzed the text in the interview transcripts using the web-based software Dedoose, which allows for rigorous qualitative analysis within a mixed-methods framework. Data analysis began immediately upon transcription to identify emergent issues that warranted further exploration in subsequent interviews. We used qualitative content analysis methods and a deliberative approach (Hsieh and Shannon 2005; Sandelowski 2000). We analyzed the first two transcribed interviews from the same stakeholder group (psychiatrists) and created a draft codebook. We based several codes on core aspects of the questions asked during the interviews. We analyzed another two transcripts from the same stakeholder group to see if the codebook needed to be adjusted. After this, the team convened to reach consensus on the framework, themes, sub-themes, and codebook. We used the developed codebook to code the transcripts of the other two stakeholder groups, revising this where necessary in order to allow for the emergence of themes not found in the first group’s interviews. Team meetings provided further opportunities to revise the codebook as necessary (for example by refining, merging, and/or distinguishing categories and themes); this process allowed us to reach a consensus on coding discrepancies. In our Findings section below, we present relevant quotes to highlight the findings with non-content words and expressions removed for readability.

Findings

Perceived Risks

Each stakeholder group most frequently mentioned the risk of memory loss (or cognitive issues in general) when discussing ECT. Psychiatrists referred to patients’ concerns and their assessments from the medical literature. Most of the public participants discussed either family or friends who have had ECT or their own exposure to depictions of it in popular culture.

“I would say the cognitive complaints are probably the biggest concern that [patients] have.” Psychiatrist 11

“I think that a potential risk might be that it changes your brain for good...like the memory loss, they say ‘short-term memory loss’ and it’s not permanent. Well, what if it is permanent?” Patient 13

“I recall from prior knowledge that short-term memory difficulties could arise from ECT.” Public 04

Participants generally perceived rTMS as having only minor risks and side effects, such as headaches and transient skin reactions. Most patient and public participants referenced information they read in the two-pages document they received prior to the interview, as many were not aware of this electroceutical before this.

“[T]here’s really not a ton of side effects with [r]TMS. I mean maybe a little bit of a headache.” Patient 06

“I don’t see any major side effects.” Public 12

Participants asked about DBS mentioned several risks of having something implanted in the brain, such as bleeding, infections, or the implant affecting other areas of the brain that were not the original target. Participants also raised concerns about the uncertainties that come with the use of this intervention for psychiatric disorders.

“[T]hey’re going to be a much higher level of side effects … there is the surgical side effects, there is the post-surgical side effects, the risks of infection, there are the side effects that people are going to begin to be experiencing after they have had the equipment implanted and in use.” Psychiatrist 3

“I guess the biggest risk is that […] side effects and longer-term effects are basically totally unknown.” Patient 16

“Brain surgery is always a big risk.” Public 07

Patients did mention one type of risk that no other stakeholder group volunteered—that electroceuticals could cause ongoing problems. Patients described this as the possibility for permanent damage or for residual effects that would last long-term.

“I think the risks of [rTMS/DBS] would be permanent damage… can they be specific enough to hit the exact spot and […] is it going to have any residual effects?” Patient 04

“Could that hurt me long-term or could that disrupt other functions of the brain?” Patient 03

When comparing electroceuticals with psychotherapy, participants emphasized how distinct types of interventions produce distinct types of risks. For instance, participants viewed electroceuticals as leading to more physical risks and psychotherapy as producing more emotional ones.

“[T]he risk of psychotherapy is not being effective enough earlier in the course of the illness. But there is obviously no direct memory impairment from psychotherapy.” Psychiatrist 11

“[r]TMS has more side effects physically. But I think psychotherapy can have emotional side effects.” Patient 13

“Psychotherapy might be lower risk physically, higher risk emotionally…” Public 01

When comparing electroceuticals with medication, participants were divided on whether ECT was more or less risky than pharmaceuticals, but there was more agreement that rTMS had a smaller or equivalent risk profile to that of medication. The majority of participants assessed DBS as posing a greater risk than medication.

“[T]he side effect profile is better with [r]TMS than with medications.” Psychiatrist 10

“I found the side effects from meds to be more problematic [than ECT] because it’s an everyday thing and they sometimes get cumulative or when you change it, you’ll get different ones.” Patient 12

“I think [DBS] would be more risky than the medications. … I would be more afraid of the secondary effects of the electric therapies.” Public 09

Compared to a brain stent (an invasive non-mental health treatment), psychiatrists considered all electroceuticals to have fewer risks and side effects. Patient and public participants were unsure about the risks and side effects of electroceuticals compared to brain stents. Some of these participants thought there could be more side effects from brain stents than from ECT and rTMS, since the former are more invasive than the latter. Yet, they perceived stents and DBS to have a similar level of invasiveness and, therefore, risks. Although, as one patient mentioned, “DBS has its own unique [risks], because it could theoretically like change your personality or there could be all these weird odd effects” (Patient 16).

Finally, when comparing electroceuticals with using a brain implant for movement disorders, our participants again used the level of physical invasiveness to judge some of the risks. Some acknowledged that an implant’s risks and side effects can vary based on the disorder treated, while others (especially the patient and public participants) thought the risks and side effects are similar regardless of which indication is used for.

“I would think that [DBS for movement disorders] would be higher risk procedures compared to ECT.” Psychiatrist 11

“So, because it’s a different area of your brain, I would think there is potential of possible different side effects.” Patient 15

“I feel like they would be about the same. I mean they might target different brain areas, but I think there is always the potential for the wrong brain area to be targeted or for it to target another part of the brain area.” Patient 02

Perceived Benefits

Effectiveness and quick response were the two most common benefits mentioned across all three stakeholder groups when comparing the discussed electroceutical with other treatments. Psychiatrists mentioned rapid response almost entirely in reference to ECT. Patient and public participants mostly brought up rapid response when comparing benefits of electroceuticals over medication or psychotherapy, as they saw these interventions as providing faster relief than the other two therapies.

“[ECT is] the most rapidly acting antidepressant method that we have.” Psychiatrist 06

“ [DBS] seems like something that’s directly tying into the brain and sending these impulses… would have a stronger impact than a pill.” Patient 03

“I guess faster in the sense that it seemed like [ECT] would be useful for people who were at high-risk of like suicide or something like that.” Public 01

Psychiatrists mentioned effectiveness as a key benefit of ECT; patients discussed effectiveness when comparing the benefits of electroceuticals to medication or therapy broadly; while the public participants mostly referenced effectiveness when discussing DBS.

“ECT is still the most effective treatment we have, but it does come at […]a cost, both in terms of just the procedure itself as well as just some people can be a little bit cognitively different.” Psychiatrist 04

“I don’t know how many people ECT works for, but it seems to continue to be an effective treatment when other things don’t work.” Patient 12

“[DBS] would be more effective than seeing a counselor and taking medication. And my guess is that it would be more permanent, and I do see the value in that.” Public 13

In comparing the benefits of either ECT or rTMS against psychotherapy, the majority of stakeholders mentioned not having to discuss potentially painful topics in detail with a therapist. When comparing electroceuticals to medications, both patient and public participants claimed not having to take a daily pill, or needing fewer medications, as a benefit.

“[O]ne of the bigger benefits […] is that it’s not a pill that you have to take every day and remember to take.” Patient 08

“[M]aybe with this type of treatment, you can only have like these sessions for X amount of time and then your brain continue works perfectly, with no more medication or no more [r]TMS. So that’s like a big pro.” Public 12

“[F]or a lot of people, the surgical treatment allows them to lower their medications [….] once the surgery has happened…that it is a net positive.” Public 07

When discussing DBS, patient and public participants mentioned that they would not have to commit time for multiple sessions, and that it is a more targeted intervention, as the stimulation is more localized.

“I think that’s one of the most appealing things about the implant is that it’s there, and it’s done, and it’s going to continue to work, whereas like everything else, you’re going to have to commit that time and that’s just hard if you’re a working parent adult with multiple things pulling at your time.” Patient 03

“An advantage over ECT is that you don’t have to keep going back in and going under anesthetic.” Patient 12

Members of each stakeholder group considered rTMS to be either non-invasive or minimally invasive. Compared to the other electroceuticals, participants saw the low risk profile of this electroceutical as another relevant benefit.

“For [r]TMS, it doesn’t work as well, but its side effect burden is trivial. Its invasiveness is, negligible.” Psychiatrist 10

“[rTMS is] non-invasive really and, it’s pretty simple.” Patient 16

Among the participants who answered our question about which electroceutical has the best benefit-risk ratio, almost three-quarters of psychiatrists selected ECT; almost equal percentages of patients selected rTMS (50%) and ECT (43%); and approximately 38% of public participants reported rTMS and DBS. In the case of ABIs, we asked all participants about their perceived benefits or risks compared to DBS, with the majority of participants responding that ABI would most likely bring more benefits than risks:

“I think an adaptive implant would be welcome and would be well worth the risk because, it is intelligently responding to some actual neural activity.” Psychiatrist 10

“I think that the benefits may be a little more because […] it is actually going by what that specific person needs.” Patient 15

“The fact that it’s not us just bombarding the brain continuously but that the implant can actually know when it’s best to stimulate, that actually might improve the benefits and diminish the risks.” Public 13

Discussion

We examined perceived risks and benefits regarding electroceuticals among three stakeholder groups: psychiatrists, people living with depression, and members of the public. The majority of each group perceived memory loss as a major risk, and efficacy and quick response as major benefits of ECT. Each stakeholder group considered rTMS to lack major risks and saw its minimal invasiveness as a key benefit. Participants were more divided on the risks and benefits of more invasive electroceuticals. Participants from each group perceived each electroceutical to have the benefit of eliciting a quick response. Our findings contribute a unique perspective and add value to the literature by examining similarities and differences in risk and benefit perceptions across three stakeholder groups and across multiple electroceuticals, both those that are FDA-approved and those currently undergoing trials.

ECT: Memory Loss vs. Effectiveness and Quick Response

Our findings suggest that memory loss and cognitive disturbances were the most commonly perceived risks associated with ECT, regardless of stakeholder group. This is consistent with the results of earlier studies (Rose et al. 2003; See also Hersh 2013; Lauber et al. 2005; McFarquhar and Thompson 2008). While formal assessments of ECT risks document that it produces only transient disturbances in recent memories (Reisner 2003; Fink 2009; Sadowsky 2017), the majority of patient and public participants believed that it could affect old memories in a permanent way. Unsurprisingly, psychiatrists’ risk perceptions of memory loss seem consistent with the current scientific literature. Experts’ risks assessments around medical applications tend to focus on observed or expected fatalities and potential benefits (Savadori et al. 2004). This likely helps explain why most psychiatrists believed that the benefits of ECT outweighed the risks for treatment-resistant depressed patients. While we observed this trend for ECT, we did not see it for perceived risks and benefits of other electroceuticals. Moreover, informed by their own professional experience, psychiatrists reported seeing the risks of untreated major depression (for example, suicide) as potentially more worrisome than the potential for transient, short-term memory loss.

As mentioned above, patient and public participants have been exposed to largely one-sided, negative portrayals of ECT (Hughes, Barraclough, and Reeve 1981; Malcolm 1989; Walter 2004; Griffiths and O’Neill-Kerr 2019). Further, these stakeholder groups seem to ground their perceptions of ECT in terms of severe outcomes (such as permanent memory loss) that evoke strong feelings of dread. The risk perception literature suggests that laypeople are often likely to overestimate the frequency of catastrophic risks that evoke dread, leading to risk-avoidance behaviors or to policies that are not necessarily in ‘people’s’ best interests (Slovic 1987), depending on whose values and interests are being considering (Szmukler 2003). Similar to previous studies showing the negative connotations of ECT (McFarquhar and Thompson 2008; Lauber et al. 2005), our patient and public participants also described the treatment as “scary,” “inhumane,” or “barbaric”.

As expected, given their expertise and professional experience, psychiatrists perceived that ECT is effective and has a quick response, which reflects the medical literature to date (Pagnin et al. 2004; Husain et al. 2004). Few patient and public participants had any prior knowledge to judge the benefits of ECT; as such, their responses were largely shaped by the information we sent them before the study. To the extent possible we tried to provide a neutral description of the technologies, without making claims that could easily bias our participants. However, for ECT, in particular, our participants were previously aware of the generally negative portrayals of ECT in popular culture. Several participants remarked that after reading the two-pager information sheet, they realized how useful this technology could be to patients in need. This realization in some of our participants is just one more example of the complex factors involved in risk and benefit perceptions and judgements.

rTMS: Minimal Risks and Minimal Invasiveness

Our participants perceived rTMS as minimally or non-invasive with a limited risk profile, reflecting descriptions in the scientific literature (George, Taylor, and Short 2013; McClintock et al. 2018). This perceived minimal physical invasiveness may be a main reason why patient and public participants viewed rTMS as having at most minimal risk.

While many psychiatrists knew patients who have received and benefited from ECT, fewer in our sample personally administered rTMS or knew patients treated with it. Likewise, knowledge of this intervention among our patient and public participants was very limited. Thus, the rTMS risk perceptions of the latter two groups were most likely shaped by affect and other heuristics that associate less invasive procedures with being safer. Previous literature has looked into how judgements of risks and benefits are negatively correlated (Fischhoff, Slovic and Lichtenstein 1978; see also Slovic et al. 2007; Skagerlund et al. 2020), which supports our finding in as much as invasive interventions are generally perceived as much riskier than non-invasive ones. Finally, we have also found that a number of factors, including familiarity and perceived capacity to cause harm, modulate perceptions of the invasiveness of PEIs (Bluhm et al. 2021)

Implantable PEIs: Invasive vs. Localized

Most participants across all stakeholder groups acknowledged the heightened level of risk related to neurosurgery for implantable electroceuticals compared with those of ECT and rTMS, and they viewed the potential precision and fast results with DBS as likely benefits. While some patients and public participants perceived the permanence of these electroceuticals as a risk, others considered it to be a benefit as they would no longer need to worry about taking pills daily. Finally, while the majority of the neuroethical debate around this technology is focused on risks of DBS negatively affecting self-related concepts (identity, personality, autonomy, and agency, for example), only a few participants raised this type of concern.

Across the stakeholder groups, our participants had limited or minimal experience with or awareness of these electroceuticals, which seems to have shaped their perceived risks and benefits. Similar to Cormier and colleagues (2019), we found that sampled psychiatrists had a low level of knowledge of DBS: only two had minimal experience and one had moderate experience with it (Supplemental file). This is not surprising given its investigational status. Further, several of our patient and public participants had never heard of DBS being investigated as a potential depression treatment, and their responses about this electroceutical were likely shaped primarily by the information handout they received prior to the interview.

In contrast with the negative portrayals of ECT in the media, these implantable technologies have had more positive media coverage (Cabrera et al. 2017), which can emphasize or perhaps overstate the potential benefits while undermining the potential risks. Moreover, given the low awareness among our public and patient participants about these interventions, some of the perceived risks and benefits reported might have been shaped by their perceptions on risk and benefits of interventions they were familiar with. For example, many new wearables monitor body measures and provide personalized feedback to the user based on the monitor measures. This could be one reason for why we found that many participants perceived adaptive implants to be more beneficial than standard DBS, where the stimulation cannot be adapted in the same personalized manner.

Implications for Clinical Practice and Policy

As noted above, those who are unfamiliar with technologies tend to assess their risk and benefits differently, in terms of both process (how they assess) and outcome (their perceptions). It is therefore important to understand not only patients’ perceptions of the benefits and risks of an intervention but also those of clinicians who are less familiar with interventions that are new or not readily available in their practice. Such information will identify potential misunderstandings and ensure that educational information about interventions addresses patient concerns. For example, in the case of ECT, individuals seemed to be more wary of memory loss and less worried about induced seizures. Thus, a main challenge is to better understand why different electroceuticals bring about different risk perceptions that might not correspond to what previous studies have found for other medical technologies.

Implantable electroceuticals are still in development as treatments for depression, so a clinical understanding of their risks and benefits is only gradually emerging. This makes it challenging to inform patients and research subjects about their potential risks and benefits. Moreover, for both these and the currently approved electroceuticals, the interventions’ mechanism of action and factors shaping who is more likely to face certain risks and benefits are not fully understood. In that regard, as some others have argued, we support the view that the process of informed consent, both in therapy and research, must include a comprehensive account of the uncertainties about these procedures (Park et al. 2017). Further, when making decisions about proceeding with the development and use of electroceuticals, clinicians must think deeply about how stakeholders’ perceived risks and benefits might change as these are approved by regulatory bodies and become more widely available. Although our findings are based on a small, non-probability sample, we hope that studies such as this one will form a useful reference point as the epistemic basis and status of these technologies evolves over time. In particular, we see our findings contributing to wider understandings of risk and this particular type of medical technologies, as different forms of knowledge are drawn upon not only by different stakeholder groups, but also by those who have experience with or awareness (that is those who are familiar) with the technology and those who do not. For example, as we mentioned earlier, psychiatrists with no experience referring patients for or administering a given intervention are more likely to draw on heuristics or other “informal approaches” to reasoning about risks (Horlick-Jones et al. 2007; Raab and Gigerenzer 2015; Zinn 2008). In a previous study we also found that level of familiarity, including people’s own previous experiences and exposures to similar types of technologies provide an important frame of reference that can shape people’s risks and benefits perceptions, even if they do not have experience with a given electroceutical intervention (Cabrera et al. 2019). Our current study also addresses the issue of how people assess medical technologies that have been used for several years and are approved by the Food and Drug Administration, versus those that novel and are still undergoing clinical trials. In this regard DBS is an interesting case study as it is novel and experimental for psychiatric disorders, but it is an established technology for movement disorders. Thus, while different technologies possess the capacity to engender specific patterns of understanding (Horlick-Jones et al. 2007), the social and cultural context in which they are embedded also shapes our understanding of them and the risks and benefits we associate with them.

Finally, risk perceptions are important from a policy-making perspective, not only because there is a need to account for the epistemological status of competing ‘expert,’ ‘layperson,’ and ‘practitioner’ evaluations of risk (Pidgeon 2008), but also because risk perceptions of medical technologies certainly include a variety of ethical or value-based concerns (Szmukler 2003). As such, there is a critical need to generate an effective dialogue on the values, visions, and wider societal implications of electroceuticals as one contribution to a process of “responsible innovation” (Garden et al. 2016).

Limitations

It is important to acknowledge some of the limitations of our study. First, we used a purposive sampling strategy to recruit participants, which likely brings a selection bias. While we attempted to collect data from a demographically diverse sample of Michigan stakeholders, we were constrained to select among interested participants, thus our findings are neither representative nor generalizable. Second, we collected data from participants using semi-structured interviews. Although semi-structured interviews are a useful tool for extracting rich and contextualized data, this approach poses a challenge when comparing and contrasting data between participants. Another limitation that inhibits comparisons across interviews is that not all participants were asked about all four electroceuticals, however, our interview instrument was the same across all stakeholder groups (with a few extra questions for particular stakeholder groups). We also acknowledge the overrepresentation of attitudes related to ECT compared to other interventions, as this was the intervention about which many participants had the most knowledge. Finally, as noted above, we provided all stakeholders with a two-page information sheet to provide some background information about the PEIs. While we aimed to produce very neutral descriptions and to provide consistent information for each of the interventions, it is possible that participants’ responses were shaped by this information, in particular for those interventions for which they were the least familiar. One goal of this study was to provide a framework for the next stage of our project—a national survey of patients, caregivers, the general public, and psychiatrists—that will overcome some of these limitations through the use of a representative national sample and objective measures and scales.

Conclusions

Electroceuticals can be valuable tools when first-line mental health treatments (e.g., psychotherapy and medication) have not provided symptom relief or remission. Each modality that we explored in this study has a distinct risk and benefit profile, though some of these profiles are very much still emerging given the novelty of the technologies. One of the most substantial impediments to informed conversations around electroceuticals are incongruities between stakeholder perceptions of the efficacy and risks associated with these modalities and clinically tested, peer-reviewed claims. An example of this lies in the decades-long conversation on ECT, a depression treatment with substantial evidence for effectiveness yet that is feared by many. It is important that proactive and engaging communication continues around the use of electroceuticals in psychiatry, to reduce unnecessarily high levels of risk aversion as well as to mitigate hype about their benefits.