Margot Paul

All Publications

• Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults with Major Depressive Disorder: A Randomized Controlled Trial. JMIR mental health Paul, M., Bullock, K., Bailenson, J., Burns, D. 2024

  Abstract

  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 numerous barriers for patients to access these treatments. Virtual reality (VR) has been used as a treatment enhancement for a variety of mental health disorders, but few have examined its efficacy and use for MDD in clinical settings. Behavioral activation (BA) is a simple yet effective EBP for MDD that may have potential to be easily enhanced and adapted with VR. A previous report by our group explored the feasibility and acceptability of VR-enhanced behavioral activation (VR-BA) in a small clinical proof of concept pilot. The present study examines the clinical efficacy of a more immersive extended reality prototype (XR-BA) based on modifications from this early pilot testing. We report on the first clinical efficacy testing of XR-BA comparing it to traditional BA.Our main objective was to corroborate previous VR-BA feasibility and tolerability findings with a more immersive extended reality prototype using a commercially available Meta QUEST 2 VR headset. In addition, this study examined whether XR-BA was efficacious and non-inferior to traditional BA in treating MDD in a clinical telemedicine setting.A nonblinded between-subjects randomized controlled trial was conducted comparing XR-BA to traditional BA remotely via a Zoom platform between December 19, 2022 and July 24, 2023. The study utilized the same brief three week, four-session BA protocol described in our previous study and in previous efficacious brief BA interventions in the literature. The main difference between study arms was the requirement for the experimental XR-BA subjects to use a Quest 2 VR headset to engage in pleasant activities instead of in real life (IRL) activities for therapy homework. The primary outcome measured was the Patient Health Questionnaire-9 (PHQ-9). Independent samples t-tests and paired-samples t-tests were used to determine statistical significance and confirmed with Statistical Equation Modeling (SEM).Of 71 participants assessed for eligibility, 26 met study criteria and were randomized to receive either XR-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). No adverse events were reported in either group, and no significant difference in dropout rates or homework completion was observed. The XR-BA intervention was found to be statistically non-inferior to traditional BA, t(18.6) = -.28, p = .78. Both the XR-BA arm, t(9) = 2.5, p = .04, and the traditional BA arm, t(10) = 2.3, p = .04 experienced a statistically significant decrease in symptoms and clinical severity from the beginning of session 1 to the beginning of session 4.This study confirmed our previous findings that XR-BA is a feasible and acceptable enhancement of traditional BA for an outpatient MDD population. The findings, although limited, also provide evidence that XR-BA is not inferior to traditional BA. XR-enhanced BA may be worth pursuing as a modality for improving access and reducing barriers to mental health for those with MDD. In addition, our data indicates further exploration is warranted to test XR's ability to enhance the expectation/placebo effects of EBP's for MDD.ClinicalTrials.gov Identifier: NCT05525390.RR2-10.2196/35526.

  View details for DOI 10.2196/52326

  View details for PubMedID 38437873

• Virtual Reality Behavioral Activation for Adults with Major Depressive Disorder: Feasibility and Randomized Controlled Trial. JMIR mental health Paul, M., Bullock, K., Bailenson, J. 2022

  Abstract

  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.

  View details for DOI 10.2196/35526

  View details for PubMedID 35404830

• Case Report: Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder. JMIR mental health Paul, M. n., Bullock, K. n., Bailenson, J. n. 2020

  Abstract

  Major depressive disorder (MDD) is a global problem with an increasing incidence and prevalence. There has additionally been an increase in depression due to the COVID-19 pandemic. Behavioral activation is considered an evidence-based treatment for MDD. However, there are many barriers that could hinder one's ability to engage in behavioral activation, with COVID-19 "shelter-in-place" and social distancing orders being current and large impediments. Virtual reality has been successfully used to help treat a variety of mental health conditions, but it has not yet been used as a method of administering behavioral activation to a clinical population. Using virtual reality to engage in behavioral activation could eliminate barriers that pandemic precautions place and help decrease symptoms of depression that are especially exacerbated in these times.The following case report examines the feasibility, acceptability, and tolerability of virtual reality behavioral activation for an adult with MDD during a global pandemic. This participant was part of a larger pilot study and the case serves as a description of the VR intervention.The participant engaged in a weekly 50-minute psychotherapy Zoom session for four weeks, in which a modified behavioral activation protocol was administered using a virtual reality headset. Data on mood ratings, homework compliance, and headset use were obtained from the headset. Acceptability, tolerability, and depression symptoms were obtained using self-report rating scales.The intervention was feasible, acceptable, and tolerable, as reported by this participant. The participant's depressive symptoms decreased by five-points on the PHQ-9 over a month, with a beginning score of a 10 (moderate depression) and a final score of a 5 (mild depression).The implications of these findings for future research are discussed.Clinicaltrials.gov NCT04268316.

  View details for DOI 10.2196/24331

  View details for PubMedID 33031046

• What Is Medical Extended Reality? A Taxonomy Defining the Current Breadth and Depth of an Evolving Field. Journal of medical extended reality Spiegel, B. M., Rizzo, A., Persky, S., Liran, O., Wiederhold, B., Woods, S., Donovan, K., Sarkar, K., Xiang, H., Joo, S., Jotwani, R., Lang, M., Paul, M., Senter-Zapata, M., Widmeier, K., Zhang, H. 2024; 1 (1): 4-12

  Abstract

  Medical extended reality (MXR) has emerged as a dynamic field at the intersection of health care and immersive technology, encompassing virtual, augmented, and mixed reality applications across a wide range of medical disciplines. Despite its rapid growth and recognition by regulatory bodies, the field lacks a standardized taxonomy to categorize its diverse research and applications. This American Medical Extended Reality Association guideline, authored by the editorial board of the Journal of Medical Extended Reality, introduces a comprehensive taxonomy for MXR, developed through a multidisciplinary and international collaboration of experts. The guideline seeks to standardize terminology, categorize existing work, and provide a structured framework for future research and development in MXR. An international and multidisciplinary panel of experts was convened, selected based on publication track record, contributions to MXR, and other objective measures. Through an iterative process, the panel identified primary and secondary topics in MXR. These topics were refined over several rounds of review, leading to the final taxonomy. The taxonomy comprises 13 primary topics that jointly expand into 180 secondary topics, demonstrating the field's breadth and depth. At the core of the taxonomy are five overarching domains: (1) technological integration and innovation; (2) design, development, and deployment; (3) clinical and therapeutic applications; (4) education, training, and communication; and (5) ethical, regulatory, and socioeconomic considerations. The developed taxonomy offers a framework for categorizing the diverse research and applications within MXR. It may serve as a foundational tool for researchers, clinicians, funders, academic publishers, and regulators, facilitating clearer communication and categorization in this rapidly evolving field. As MXR continues to grow, this taxonomy will be instrumental in guiding its development and ensuring a cohesive understanding of its multifaceted nature.

  View details for DOI 10.1089/jmxr.2023.0012

  View details for PubMedID 38505474

  View details for PubMedCentralID PMC10945763

• Embodied Virtual Reality Mirror Visual Feedback for an Adult with Cerebral Palsy American Journal of Psychiatry and Neuroscience Bullock, K. D., Stevenson Won, A., Bailenson, J., Muccin, J., Paul, M., Bronte-Stewart, H. 2021; 9 (2): 59-67

  View details for DOI 10.11648/j.ajpn.20210902.16