Participants' Perceptions of Deep Brain Stimulation Research for Treatment-Resistant Depression: Risks, Benefits, and Therapeutic Misconception

Abstract

Background: Deep brain stimulation (DBS) for treatment-resistant depression (TRD) is the focus of great interest and numerous studies. Given the state of this research, the risks of DBS, the uncertainty of direct benefits, and the potential for therapeutic misconception (TM), examination of research participants' perspectives is critical to addressing concerns about the adequacy of consent among people with TRD.

Methods: Among 31 participants considering DBS studies at two sites, self-report questionnaires were used to examine three dimensions of TM (eight true/false items). Additional Likert-scale items assessed perceptions of risks, potential benefits, and altruistic motivations.

Results: Participants correctly identified the surgery itself as the riskiest study procedure, although only four participants rated the surgery as "high risk." Most participants rated the entire DBS study as "moderate" or lower risk. Participants rated the likelihood of others benefiting in the future more strongly than they did the likelihood of personal benefit. Participants held positive attitudes toward research, and were moderately altruistic. Nearly two-thirds of the 31 participants (64.5%) answered at least one of the true/false TM items incorrectly.

Conclusions: Individuals considering DBS studies for TRD demonstrated reasonable perceptions of risks and benefits, distinguished among procedural risks, and expressed hopes for personal benefit as well as altruism. Findings related to TM were mixed: Participants understood the experimental stage of DBS for depression and endorsed the possibility of no personal benefit, yet there was some evidence for TM. Although these findings are reassuring, investigators must nevertheless remain vigilant about identifying and addressing potential misconceptions.

Keywords: informed consent; major depression; research benefits; research risks; therapeutic misconception.

Figure 1

(A) Perceived risks of specific study procedures. (B) Perceived risk of study to participant personally. (C) Perceived risk of study to people with TRD in general. (D) Participants’ ratings of overall level of risk of study.

Figure 2

(A) Participants’ ratings of likelihood of personal benefit. (B) Participants’ ratings of likelihood of benefit to people with TRD in general. (C) Participants’ ratings of altruism as a motivating factor in participation.