Paul M, Bullock K, Bailenson J. Virtual Reality Behavioral Activation for Adults With Major Depressive Disorder: Feasibility Randomized Controlled Trial. JMIR Ment Health. 2022 May 6;9(5):e35526. doi: 10.2196/35526

BACKGROUND: Major depressive disorder (MDD) is a global crisis with increasing incidence and prevalence. There are many established evidence-based psychotherapies (EBP’s) for depression, but numerous barriers still exist, most notably access and dissemination. Virtual reality (VR) may offer some solutions to existing constraints of EBP’s for MDD.OBJECTIVE: To examine the feasibility, acceptability, and tolerability of using VR as a method of delivering behavioral activation (BA) for adults diagnosed with MDD during a global pandemic. To explore for signs of clinical efficacy by comparing VR enhanced BA (VR BA) to (1) a standard BA treatment and (2) a treatment as usual (TAU) group for individuals diagnosed with MDD.METHODS: A feasibility trial using a three-armed, unblinded, randomized controlled pilot design was conducted. The study took place remotely via Zoom telehealth visits between April 8, 2020 and January 15, 2021. This study employed a three-week, four-session protocol, in which VR BA participants used a VR headset to complete their BA homework. Feasibility was measured by dropout rates, serious adverse events, completion of homework, an adapted telepresence scale, a simulator sickness questionnaire, a brief agitation measure, and an adapted technology acceptance model. Efficacy was assessed by the Patient Health Questionnaire-9 (PHQ-9).RESULTS: Of the 35 participants assessed for eligibility, 13 were randomized to VR BA (n=5), traditional BA (n=4), or a TAU control (n=4). The mean age of the 13 participants (5 male, 7 female, 1 non-binary/third gender) was 35.4 (SD = 12.3). This study demonstrated VR BA feasibility in subjects with MDD by documented high levels of acceptability and tolerability while engaging in VR induced pleasurable activities in conjunction with a brief BA protocol. No adverse events were reported. This study also illustrated that VR BA may have potential clinical utility for treating MDD, as the average VR BA participant’s clinical severity decreased by 5.67 points, signifying a clinically meaningful change in severity from a moderate to a mild level of depression, as per PHQ-9 scoring.CONCLUSIONS: The findings of this study demonstrate that VR BA is safe and feasible to explore for the treatment of MDD. This study documented evidence that VR BA may be efficacious, and it justifies examining further in an adequately powered RCT. This pilot highlights the potential utility that VR technology may offer patients with MDD, especially those who have difficulty accessing real-world pleasant activities. VR may also be a viable alternative to psychiatric medications for MDD, given its high tolerability and lack of side effects. Additionally, for those having difficulty accessing care, VR BA could be adapted as a first step to help people improve mood and increase motivation while waiting to connect with a healthcare professional for other EBP’s.CLINICALTRIAL: ClinicalTrials.gov Identifier: NCT04268316.INTERNATIONAL REGISTERED REPORT: RR2-10.2196/24331.