Paul, M., Bullock, K., Bailenson, J., & Burns, D. (under review). Examining the Efficacy of Virtual Reality-Enhanced Behavioral Activation for Adults with Major Depressive Disorder: A Randomized Controlled Trial. JMIR Ment Health Preprints, doi: 10.2196/52326

Background:

Major depressive disorder (MDD) is a global concern with increasing prevalence. While many evidence-based psychotherapies (EBPs) have been identified to treat MDD, there are many barriers to successfully doing so. Virtual reality (VR) has been used as an effective treatment tool for a variety of mental health disorders, but few have examined its effectiveness for the treatment of MDD as a primary outcome measure. While our prior study illustrated that VR is a feasible, acceptable, and tolerable method of delivering VR-enhanced behavioral activation (BA) therapy, no study to date has examined its efficacy in treating MDD.

Objective:

To examine the clinical efficacy of using VR to engage in BA compared to a traditional BA treatment for adults diagnosed with MDD. To corroborate our previous study’s findings that VR is a feasible, acceptable, and tolerable method of delivering BA for adults diagnosed with MDD.

Methods:

We conducted a nonblinded between-subjects randomized controlled trial. This study took place remotely via Zoom telehealth between December 19, 2022 and July 24, 2023. This study utilized the same brief three week, four-session BA protocol documented in our previous study, with the main difference being this study’s VR-enhanced BA participants used the more immersive and interactive Meta Quest 2 VR headset to complete their BA homework. The primary outcome was measured by the Patient Health Questionnaire-9 (PHQ-9). The secondary outcome was measured by dropout rates, serious adverse events, completion of homework, an adapted telepresence scale, a simulator sickness questionnaire, and an adapted technology acceptance model.

Results:

Of 71 participants assessed for eligibility, 26 were recruited and randomized to receive either VR-enhanced BA (n=13) or traditional BA (n=13). The mean age of the 26 participants (6 male, 19 female, 1 non-binary/third gender) was 50.3 (SD = 17.3). This study demonstrated that VR-enhanced BA is as efficacious as traditional BA in treating symptoms of depression, as both groups experienced a statistically significant decrease in symptoms as measured by the PHQ-9, with both groups experiencing about a 4-point decrease in symptoms between sessions 1 and 4. This study also corroborated our previous study’s findings 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 serious adverse events were reported.

Conclusions:

The findings of this study demonstrate that VR-enhanced BA is efficacious in treating adults with symptoms of MDD, akin to a traditional BA protocol. The findings also corroborate that VR-enhanced BA is a feasible treatment for MDD. Clinicians can consider incorporating VR into their BA treatment protocol, as indicated by patient presentation, in order to decrease barriers to care. Clinical Trial: ClinicalTrials.gov Identifier: NCT05525390