Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial.

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 numerous barriers to patients accessing them. Virtual reality (VR) has been used as a treatment enhancement for a variety of mental health disorders, but few studies have examined its clinical use in treating MDD. Behavioral activation (BA) is a simple yet effective and established first-line EBP for MDD that has the potential to be easily enhanced and adapted with VR technology. A previous report by our group explored the feasibility and acceptability of VR-enhanced BA in a small clinical proof-of-concept pilot. This study examines the clinical efficacy of a more immersive extended reality (XR)-enhanced BA (XR-BA) prototype. This is the first clinical efficacy test of an XR-BA protocol. OBJECTIVE: This study examined whether XR-BA was feasible and efficacious in treating MDD in an ambulatory telemedicine clinic. METHODS: A nonblinded between-subject randomized controlled trial compared XR-BA to traditional BA delivered via telehealth. The study used a previously established, brief 3-week, 4-session BA EBP intervention. The experimental XR-BA participants were directed to use a Meta Quest 2 (Reality Labs) VR headset to engage in simulated pleasant or mastery activities and were compared to a control arm, which used only real-life mastery or pleasant activities as between-session homework. The Patient Health Questionnaire (PHQ)-9 was the primary outcome measure. Independent-sample and paired-sample t tests (2-tailed) were used to determine statistical significance and confirmed using structural equation modeling. RESULTS: Overall, 26 participants with MDD were randomized to receive either XR-BA (n=13, 50%) or traditional BA (n=13, 50%). The mean age of the 26 participants (n=6, 23% male; n=19, 73% female; n=1, 4% nonbinary or third gender) was 50.3 (SD 17.3) years. No adverse events were reported in either group, and no substantial differences in dropout rates or homework completion were observed. XR-BA was found to be statistically noninferior to traditional BA (t18.6=-0.28; P=.78). Both the XR-BA (t9=2.5; P=.04) and traditional BA (t10=2.3; P=.04) arms showed a statistically significant decrease in PHQ-9 and clinical severity from the beginning of session 1 to the beginning of session 4. There was a significant decrease in PHQ-8 to PHQ-9 scores between the phone intake and the beginning of session 1 for the XR-BA group (t11=2.6; P=.03) but not the traditional BA group (t11=1.4; P=.20). CONCLUSIONS: This study confirmed previous findings that XR-BA may be a feasible, non-inferior, and acceptable enhancement to traditional BA. Additionally, there was evidence that supports the potential of XR to enhance expectation or placebo effects. Further research is needed to examine the potential of XR to improve access, outcomes, and barriers to MDD care. TRIAL REGISTRATION: ClinicalTrials.gov NCT05525390; https://clinicaltrials.gov/study/NCT05525390.

Augmenting group hoarding disorder treatment with virtual reality discarding: A pilot study in older adults.

Hoarding disorder is common and debilitating, especially in older adults, and novel treatment approaches are needed. Many current treatments emphasize skills related to discarding and decision-making about possessions, which can be practiced in the patient's home. However in many cases, in-home visits are unfeasible, or real-life discarding is too difficult. Virtual reality (VR) offers the ability to create a virtual "home" including 3D scans of the patient's actual possessions that can be moved or discarded. VR discarding is an alternative to in-home visits and an approach that provides a stepping stone to real-life discarding. VR has been successfully utilized to treat many disorders but tested minimally in hoarding disorder. In nine older adults with hoarding disorder, we tested an 8-week VR intervention administered to augment a 16-week Buried in Treasures group treatment. Individualized VR rooms were uniquely modeled after each patient's home. During clinician-administered VR sessions, patients practiced sorting and discarding their virtual possessions. The intervention was feasible to administer. Open-ended participant responses, examined by two independent evaluators, indicated that VR sessions were well-tolerated and that participants found them useful, with nearly all participants noting that VR helped them increase real-life discarding. Self-reported hoarding symptoms decreased from baseline to close, with seven of the nine participants showing reliable improvement in this timeframe and none showing deterioration. Results from this exploratory pilot study suggest that VR is a feasible way to simulate an at-home sorting and discarding experience in a manner that may augment skills acquisition. It remains an open question whether VR discarding practice yields greater improvement than existing treatments. VR for this population merits further clinical investigation.

A Systematic Review of using Virtual and Augmented Reality for the Diagnosis and Treatment of Psychotic Disorders.

Objective: Immersive virtual reality (VR) and augmented reality (AR) have the potential to improve the treatment and diagnosis of individuals experiencing psychosis. Although commonly used in creative industries, emerging evidence reveals that VR is a valuable tool to potentially improve clinical outcomes, including medication adherence, motivation, and rehabilitation. However, the efficacy and future directions of this novel intervention require further study. The aim of this review is to search for evidence of efficacy in enhancing existing psychosis treatment and diagnosis with AR/VR. Methods: 2069 studies involving AR/VR as a diagnostic and treatment option were reviewed via PRISMA guidelines in five databases: PubMed, PsychInfo, Embase, and CINAHL. Results: Of the initial 2069 articles, 23 original articles were eligible for inclusion. One study applied VR to the diagnosis of schizophrenia. Most studies demonstrated that the addition of VR therapies and rehabilitation methods to treatment-as-usual (medication, psychotherapy, social skills training) was more effective than traditional methods alone in treating psychosis disorders. Studies also support the feasibility, safety, and acceptability of VR to patients. No articles using AR as a diagnostic or treatment option were found. Conclusions: VR is efficacious in diagnosing and treating individuals experiencing psychosis and is a valuable augmentation of evidence-based treatments. Supplementary Information: The online version contains supplementary material available at 10.1007/s40501-023-00287-5.

Functional neurological disorder is a feminist issue.

Functional neurological disorder (FND) is a common and disabling disorder, often misunderstood by clinicians. Although viewed sceptically by some, FND is a diagnosis that can be made accurately, based on positive clinical signs, with clinical features that have remained stable for over 100 years. Despite some progress in the last decade, people with FND continue to suffer subtle and overt forms of discrimination by clinicians, researchers and the public. There is abundant evidence that disorders perceived as primarily affecting women are neglected in healthcare and medical research, and the course of FND mirrors this neglect. We outline the reasons why FND is a feminist issue, incorporating historical and contemporary clinical, research and social perspectives. We call for parity for FND in medical education, research and clinical service development so that people affected by FND can receive the care they need.

Virtual Reality Behavioral Activation for Adults With Major Depressive Disorder: Feasibility Randomized Controlled Trial.

BACKGROUND: Major depressive disorder (MDD) is a global crisis with increasing incidence and prevalence. There are many established evidence-based psychotherapies (EBPs) for depression, but numerous barriers still exist; most notably, access and dissemination. Virtual reality (VR) may offer some solutions to existing constraints of EBPs for MDD. OBJECTIVE: We aimed 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 and to explore for signs of clinical efficacy by comparing VR-enhanced BA (VR BA) to a standard BA treatment and a treatment as usual control group for individuals diagnosed with MDD. METHODS: A feasibility trial using a 3-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 used a 3-week, 4-session protocol in which VR BA participants used a VR headset to complete their BA homework. Feasibility was measured using dropout rates, serious adverse events, completion of homework, an adapted telepresence scale, the Simulator Sickness Questionnaire, the Brief Agitation Measure, and an adapted Technology Acceptance Model. Efficacy was assessed using the Patient Health Questionnaire-9. RESULTS: Of the 35 participants assessed for eligibility, 13 (37%) were randomized into VR BA (n=5, 38%), traditional BA (n=4, 31%), or a treatment as usual control (n=4, 31%). The mean age of the 13 participants (5/13, 38% male; 7/13, 54% female; and 1/13, 8% nonbinary or third gender) was 35.4 (SD 12.3) years. This study demonstrated VR BA feasibility in participants with MDD through 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 the Patient Health Questionnaire-9 score. 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 justifies further examination in an adequately powered randomized controlled trial. This pilot study highlights the potential utility that VR technology may offer patients with MDD, especially those who have difficulty accessing real-world pleasant activities. In addition, for those having difficulty accessing care, VR BA could be adapted as a first step to help people improve their mood and increase their motivation while waiting to connect with a health care professional for other EBPs. TRIAL REGISTRATION: ClinicalTrials.gov NCT04268316; https://clinicaltrials.gov/ct2/show/NCT04268316. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/24331.

Translating Virtual Reality Cue Exposure Therapy for Binge Eating into a Real-World Setting: An Uncontrolled Pilot Study.

Binge-eating disorder (BED) and bulimia nervosa (BN) have adverse psychological and medical consequences. Innovative interventions, like the integration of virtual reality (VR) with cue-exposure therapy (VR-CET), enhance outcomes for refractory patients compared to cognitive behavior therapy (CBT). Little is known about the feasibility and acceptability of translating VR-CET into real-world settings. To investigate this question, adults previously treated for BED or BN with at least one objective or subjective binge episode/week were recruited from an outpatient university eating disorder clinic to receive up to eight weekly one-hour VR-CET sessions. Eleven of 16 (68.8%) eligible patients were enrolled; nine (82%) completed treatment; and 82% (9/11) provided follow-up data 7.1 (SD = 2.12) months post-treatment. Overall, participant and therapist acceptability of VR-CET was high. Intent-to-treat objective binge episodes (OBEs) decreased significantly from 3.3 to 0.9/week (p < 0.001). Post-treatment OBE 7-day abstinence rate for completers was 56%, with 22% abstinent for 28 days at follow-up. Among participants purging at baseline, episodes decreased from a mean of one to zero/week, with 100% abstinence maintained at follow-up. The adoption of VR-CET into real-world clinic settings appears feasible and acceptable, with a preliminary signal of effectiveness. Findings, including some loss of treatment gains during follow-up may inform future treatment development.

Virtual Reality Behavioral Activation as an Intervention for Major Depressive Disorder: Case Report.

BACKGROUND: 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 (VR) 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 VR 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. OBJECTIVE: The following case report examines the feasibility, acceptability, and tolerability of VR 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. METHODS: The participant engaged in a weekly 50-minute psychotherapy Zoom session for 4 weeks, in which a modified behavioral activation protocol was administered using a VR headset to simulate activities. 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. RESULTS: The intervention was feasible, acceptable, and tolerable, as reported by this participant. The participant's depressive symptoms decreased by five-points on the Patient Health Questionnaire-9 over a month, with a beginning score of 10 (moderate depression) and a final score of 5 (mild depression). CONCLUSIONS: The implications of these findings for future research are discussed. TRIAL REGISTRATION: ClinicalTrials.gov NCT04268316; http://clinicaltrials.gov/ct2/show/NCT04268316.

Bringing Virtual Reality From Clinical Trials to Clinical Practice for the Treatment of Eating Disorders: An Example Using Virtual Reality Cue Exposure Therapy.

Novel treatment options for eating disorders (EDs) are critically needed to enhance treatment outcomes and reduce the rates of treatment dropouts. On average, only 50% of individuals receiving evidence-based care remit, whereas 24% drop out before treatment completion. One particularly promising direction involves integrating virtual reality (VR) with existing evidence-based treatments (EBTs) such as cue exposure therapy (CET). Across psychiatric disorders, VR-based interventions are demonstrating at least preliminary efficacy and noninferiority to traditional treatments. Furthermore, VR technology has become increasingly portable, resulting in improved acceptance, increased access, and reductions in cost. However, more efficient research processes may be needed to uncover the potential benefits of these rapid technological advances. This viewpoint paper reviews existing empirical support for integrating VR with EBTs (with a focus on its use with EDs) and proposes key next steps to more rapidly bring this innovative technology-based intervention into real-world clinic settings, as warranted. VR-CET for EDs is used to illustrate a suggested process for developing such treatment enhancements. We recommend following a deployment-focused model of intervention development and testing to enable rapid implementation of robust, practice-ready treatments. In addition, our review highlights the need for a comprehensive clinical protocol that supports clinicians and researchers in the implementation and testing of VR-CET and identifies key missing protocol components with rationale for their inclusion. Ultimately, this work may lead to a more complete understanding of the full potential of the applications and integrations of VR into mental health care globally.

Virtual Reality-Delivered Mirror Visual Feedback and Exposure Therapy for FND: A Midpoint Report of a Randomized Controlled Feasibility Study.

OBJECTIVE: The aim was to provide preliminary feasibility, safety, and efficacy data for a personalized virtual reality-delivered mirror visual feedback (VR-MVF) and exposure therapy (VR-ET) intervention for functional neurological disorder (FND). METHODS: Midpoint results of a single-blind, randomized controlled pilot are presented. Fourteen adults were randomly assigned to eight weekly 30-minute VR sessions-seven in the treatment arm and seven in the control arm. The treatment arm consisted of an immersive avatar-embodied VR-MVF treatment, plus optional weekly VR-ET starting at session 4 if participants had identifiable FND triggers. The control arm received equally immersive nonembodied sessions involving exploration of a virtual interactive space. Feasibility was measured by acceptability of randomization, completion rates, side effects, adverse events, and integrity of blinding procedures. Exploratory primary and secondary outcome measures were weekly symptom frequency and the Oxford Handicap Scale, respectively. RESULTS: Two early dropouts occurred in the treatment arm, resulting in an 86% completion rate (N=12/14). No side effects or adverse events were reported. Blind assessment at study end indicated that two of the seven treatment arm and three of the seven control arm participants incorrectly guessed their assignment. Changes in mean symptom frequency and disability were reported, but data will not be statistically analyzed until study end. CONCLUSIONS: This study is the first to report on MVF and VR for treatment of FND. Results generated thus far support feasibility and justify continuation of the study and further investigation into the efficacy of VR interventions for FND.

COVID-19 and mental health: A review and the role of telehealth and virtual reality.

On March 12, 2020, with more than 20,000 confirmed cases and almost 1000 deaths in the European Region, the World Health Organization classified the COVID-19 outbreak as a pandemic. As of August 15, 2020, there are 21.5 million confirmed cases of COVID-19 and over 766,000 deaths from the virus, worldwide. Most governments have imposed quarantine measures of varied degrees of strictness on their populations in attempts to stall the spread of the infection in their communities. However, the isolation may have inflicted long-term psychological injury to the general population and, in particular, to at-risk groups such as the elderly, the mentally ill, children, and frontline healthcare staff. In this article, we offer the most up-to-date review of the effects of COVID-19 confinement on all the disorders listed in the Diagnostic and Statistical Manual of Mental Disorders. We make data-driven predictions of the impact of COVID-19 confinement on mental health outcomes and discuss the potential role of telemedicine and virtual reality in mental health screening, diagnosis, treatment, and monitoring, thus improving the above outcomes in such a difficult time.

Key Considerations for Incorporating Conversational AI in Psychotherapy.

Conversational artificial intelligence (AI) is changing the way mental health care is delivered. By gathering diagnostic information, facilitating treatment, and reviewing clinician behavior, conversational AI is poised to impact traditional approaches to delivering psychotherapy. While this transition is not disconnected from existing professional services, specific formulations of clinician-AI collaboration and migration paths between forms remain vague. In this viewpoint, we introduce four approaches to AI-human integration in mental health service delivery. To inform future research and policy, these four approaches are addressed through four dimensions of impact: access to care, quality, clinician-patient relationship, and patient self-disclosure and sharing. Although many research questions are yet to be investigated, we view safety, trust, and oversight as crucial first steps. If conversational AI isn't safe it should not be used, and if it isn't trusted, it won't be. In order to assess safety, trust, interfaces, procedures, and system level workflows, oversight and collaboration is needed between AI systems, patients, clinicians, and administrators.

Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study.

BACKGROUND: Therapeutic virtual reality (VR) has emerged as an efficacious treatment modality for a wide range of health conditions. However, despite encouraging outcomes from early stage research, a consensus for the best way to develop and evaluate VR treatments within a scientific framework is needed. OBJECTIVE: We aimed to develop a methodological framework with input from an international working group in order to guide the design, implementation, analysis, interpretation, and communication of trials that develop and test VR treatments. METHODS: A group of 21 international experts was recruited based on their contributions to the VR literature. The resulting Virtual Reality Clinical Outcomes Research Experts held iterative meetings to seek consensus on best practices for the development and testing of VR treatments. RESULTS: The interactions were transcribed, and key themes were identified to develop a scientific framework in order to support best practices in methodology of clinical VR trials. Using the Food and Drug Administration Phase I-III pharmacotherapy model as guidance, a framework emerged to support three phases of VR clinical study designs-VR1, VR2, and VR3. VR1 studies focus on content development by working with patients and providers through the principles of human-centered design. VR2 trials conduct early testing with a focus on feasibility, acceptability, tolerability, and initial clinical efficacy. VR3 trials are randomized, controlled studies that evaluate efficacy against a control condition. Best practice recommendations for each trial were provided. CONCLUSIONS: Patients, providers, payers, and regulators should consider this best practice framework when assessing the validity of VR treatments.

Systemwide Initiative Documents Robust Health Screening for Adults With Intellectual Disability.

It is well documented that adults with intellectual disability (ID) experience higher rates of a series of health conditions compared to their peers without disability. These health conditions include cardiovascular disease, obesity, diabetes, gastrointestinal disorders, and psychiatric and behavioral disorders. With life expectancy approximating the general population, adults with ID are also now experiencing health conditions related to aging, further increasing their risk for diminished function and well-being. This increased morbidity poses new challenges in geriatric healthcare planning for this population. Relatively simple health prevention practices, such as the implementation of a health screening tool, can substantially increase disease detection and clinical activities directed toward improved health outcomes for people with ID. This study examines data collected from the District of Columbia Developmental Disabilities Administration's (DC DDA's) health screening component of its Health and Wellness Standards. Findings are presented, along with recommendations and implications for improving preventive health screening practices in the ID population.

Group Dialectical-Behavior Therapy Skills Training for Conversion Disorder With Seizures.

Neuroimaging evidence suggests deficits in affective regulation in conversion disorder (CD). Dialectical-behavior therapy skills training (DBT-ST) was developed to target emotion dysregulation. This study was aimed to test the feasibility of stand-alone DBT-ST for CD using Linehan's manual for borderline personality disorder. In a prospective naturalistic design, 19 adult outpatients diagnosed with video EEG-confirmed seizure type CD were recruited and received weekly group DBT. Seventeen out of 19 subjects finished an average of 20.5 weeks of treatment. The mean seizure rate decreased by 66%. Cessation of seizures occurred in 35% of the sample. Completion rates reached 90%.

Emergency medicine workforce issues affect hospital efficiency.

Improving efficiency and quality in emergency departments is a crucial issue for hospital leaders and depends on changing physician performance. Shortages of residency-trained emergency physicians results in a need for collaborative staffing models and a continued reliance on physicians who trained in other specialties, especially family medicine. Healthcare executives need to identify the unique needs of their institutions, but also be aware of the strengths that family physicians possess in patient-centered care.