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Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder: A Feasibility and Pilot Randomized Controlled Trial (Preprint)


 UNSTRUCTURED
 Context: 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 they present with various limitations. Virtual reality (VR) may offer some solutions to these limitations of existing MDD EBP’s. 

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 the degree of clinical efficacy of using VR to engage in BA compared to (1) a BA treatment as usual and (2) a non-treatment control group for individuals diagnosed with MDD.

Design, Settings, Participants: We conducted a feasibility trial and a three-arm nonblinded between-subjects pilot randomized controlled trial. This study took place remotely via Zoom telehealth between April 8, 2020 and January 15, 2021. 
Intervention: This study employed a three week, four-session BA protocol, where the VR BA participants used a VR headset to complete their BA homework. 

Outcome Measures: The primary outcome 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. The secondary outcome was measured by the Patient Health Questionnaire-9 (PHQ-9). 

Results: Of the 35 participants assessed for eligibility, 13 were randomized to VR BA (n=5), BA TAU (n=4), or a non-treatment 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 that VR is a feasible, acceptable, and tolerable method of experiencing pleasurable activities in conjunction with a brief BA protocol for individuals diagnosed with MDD. No adverse events were reported. This study also illustrated that VR BA has potential clinical utility in treating symptoms of depression, as the average VR BA participant diagnosis changed from a moderate severity level to mild depression, with a clinically significant average decrease of 5.67 on the PHQ-9.

Conclusion: The findings of this study demonstrate that VR BA is a feasible treatment for MDD. This study documented evidence of VR BA’s efficacy and further justification to explore its true effect in an adequately powered RCT. This pilot documented the potential utility that VR could 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.
 
 
 INTERNATIONAL REGISTERED REPORT
 RR2-10.2196/24331 
