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STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.

ABSTRACT: BACKGROUND:Social Anxiety Disorder (SAD) is characterized by an intense fear of negative judgement by others. Cognitive Behavioral Therapy (CBT) is recommended for treatment, but a substantial part of individuals with SAD either do not seek treatment or drop-out. CBT with Virtual Reality (VR)-based exposure has several advantages compared to traditional exposure methods, mainly due to increased control of situational elements. The aim of the current study is to develop a CBT program containing VR-based exposure. The intervention is targeted to adult patients suffering from SAD and treatment effect will be assessed by changes in SAD symptoms. METHODS:This article describes the study protocol of a Randomized Controlled Trial with three arms: 1) CBT with VR exposure based on 360° videos 2) CBT with in vivo exposure and 3) VR relaxation therapy. There will be 30 participants in each arm with a crossover at the end of the treatment period during which the participants in the third group will be randomly re-allocated to one of the two former groups. The treatment program consists of 10 weekly individual sessions with a psychologist, and a six month follow-up consisting of a questionnaire. The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS). DISCUSSION:There are currently no published studies on CBT with VR exposure based on 360° videos for SAD treatment. Furthermore, the current study will be the first Danish SAD treatment program that includes VR technology. TRIAL REGISTRATION:clinicaltrials.gov (NCT03973541) June 3rd 2019.

SUBMITTER: Clemmensen L

PROVIDER: S-EPMC6990574 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.

Clemmensen Lars L Bouchard Stéphane S Rasmussen Johan J Holmberg Trine Theresa TT Nielsen Jakob Hyldig JH Jepsen Jens Richardt Møllegaard JRM Lichtenstein Mia Beck MB

BMC psychiatry 20200130 1

<h4>Background</h4>Social Anxiety Disorder (SAD) is characterized by an intense fear of negative judgement by others. Cognitive Behavioral Therapy (CBT) is recommended for treatment, but a substantial part of individuals with SAD either do not seek treatment or drop-out. CBT with Virtual Reality (VR)-based exposure has several advantages compared to traditional exposure methods, mainly due to increased control of situational elements. The aim of the current study is to develop a CBT program cont ...[more]

PMID: 32000725

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Project description:Background: Convincing evidence on Virtual Reality (VR) exposure for phobic anxiety disorders has been reported, however, the benchmark and golden standard for phobia treatment is in vivo exposure. For direct treatment comparisons, the control of confounding variables is essential. Therefore, the comparison of VR and in vivo exposure in studies applying an equivalent amount of exposure in both treatments is necessary. Methods: We conducted a systematic search of reports published until June 2019. Inclusion criteria covered the diagnosis of Specific Phobia, Social Phobia, or Agoraphobia, and a randomized-controlled design with an equivalent amount of exposure in VR and in vivo. We qualitatively reviewed participants' characteristics, materials, and the treatment procedures of all included studies. For quantitative synthesis, we calculated Hedges' g effect sizes for the treatment effects of VR exposure, in vivo exposure, and the comparison of VR to in vivo exposure in all studies and separately for studies on each diagnosis. Results: Nine studies (n = 371) were included, four on Specific Phobia, three on Social Phobia, and two on Agoraphobia. VR and in vivo exposure both showed large, significant effect sizes. The comparison of VR to in vivo exposure revealed a small, but non-significant effect size favoring in vivo (g = -0.20). Specifically, effect sizes for Specific Phobia (g = -0.15) and Agoraphobia (g = -0.01) were non-significant, only for Social Phobia we found a significant effect size favoring in vivo (g = -0.50). Except for Agoraphobia, effect sizes varied across studies from favoring VR to favoring in vivo exposure. Conclusions: We found no evidence that VR exposure is significantly less efficacious than in vivo exposure in Specific Phobia and Agoraphobia. The wide range of study specific effect sizes, especially in Social Phobia, indicates a high potential of VR, but also points to the need for a deeper investigation and empirical examination of relevant working mechanisms. In Social Phobia, a combination of VR exposure with cognitive interventions and the realization of virtual social interactions targeting central fears might be advantageous. Considering the advantages of VR exposure, its dissemination should be emphasized. Improvements in technology and procedures might even yield superior effects in the future.

Project description:BackgroundSocial anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT.DesignThis article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes.DiscussionThe study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of patients needed for a confirmatory RCT.Trial registrationClinicalTrials.gov: NCT02360033 ; date of registration: 21 January 2015.

Project description:BackgroundVirtual reality (VR) is as effective a technique as traditional cognitive behavioral therapy (CBT) and a promising tool for treating panic disorder symptoms because VR exposure can be safer and has better acceptability than in vivo exposure and is more immersive than exposure through imagination. CBT techniques can be delivered more effectively using VR as well. So far, VR has required high-quality devices, but the development of mobile VR technology has improved user availability. At the same time, a well-structured form of VR can be reproduced and used anywhere. This means that VR can be used to provide a self-guided form of treatment and address the high treatment costs of evidence-based therapy and the lack of professional therapists. This study aimed to investigate the potential of self-guided VR as an alternative to high-cost treatment.ObjectiveThe main goal of this study was to offer data about the efficacy of a mobile app-based self-led VR CBT in the treatment of panic disorder.MethodsA total of 54 subjects with panic disorder were enrolled in this study and randomly assigned to either the VR treatment group or waitlist group. The VR treatment was designed to be total 12 sessions for 4 weeks. The VR treatment consists of 4 steps in which patients are gradually exposed to phobic stimuli while learning to cope with panic symptoms in each stage. The effectiveness of treatment was assessed through the Panic Disorder Severity Scale, Hamilton Rating Scale for Depression, Body Sensations Questionnaire, Albany Panic and Phobia Questionnaire, Anxiety Sensitivity Index, State-Trait Anxiety Inventory, Hospital Anxiety and Depression Scale, Korean Inventory of Social Avoidance and Distress Scale, Korean Inventory of Depressive Symptomatology, and Perceived Stress Scale. In addition, physiological changes using heart rate variability were evaluated.ResultsIn within-group analyses, the VR treatment group exhibited improvements in panic disorder symptoms, anxiety, and depression after 4 weeks, while the waitlist group did not show any significant improvement. Compared to the waitlist group, the VR treatment group showed significantly greater improvements in the Panic Disorder Severity Scale in both completer analysis and intention-to-treat analysis. Heart rate variability in the VR treatment group showed improvement in normalized high frequency from baseline to postassessment with no significant differences in any outcome measure between groups.ConclusionsThe self-guided, mobile app-based VR intervention was effective in the treatment of panic symptoms and restoring the autonomic nervous system demonstrating the validity of the use of VR for self-guided treatment. VR treatment can be a cost-effective therapeutic approach.Trial registrationClinicalTrials.gov NCT04985019; https://clinicaltrials.gov/ct2/show/NCT04985019.

Project description:In virtual reality exposure therapy (VRET) for anxiety disorders, sense of presence in the virtual environment is considered the principal mechanism that enables anxiety to be felt. Existing studies on the relation between sense of presence and level of anxiety, however, have yielded mixed results on the correlation between the two. In this meta-analysis, we reviewed publications on VRET for anxiety that included self-reported presence and anxiety. The comprehensive search of the literature identified 33 publications with a total of 1196 participants. The correlation between self-reported sense of presence and anxiety was extracted and meta-analyzed. Potential moderators such as technology characteristics, sample characteristics including age, gender and clinical status, disorder characteristics and study design characteristics such as measurements were also examined. The random effects analysis showed a medium effect size for the correlation between sense of presence and anxiety (r = .28; 95% CI: 0.18-0.38). Moderation analyses revealed that the effect size of the correlation differed across different anxiety disorders, with a large effect size for fear of animals (r = .50; 95% CI: 0.30-0.66) and a no to small effect size for social anxiety disorder (r = .001; 95% CI: -0.19-0.19). Further, the correlation between anxiety and presence was stronger in studies with participants who met criteria for an anxiety disorder than in studies with a non-clinical population. Trackers with six degrees of freedom and displays with a larger field of view resulted in higher effect sizes, compared to trackers with three degrees of freedom and displays with a smaller field of view. In addition, no difference in effect size was found for the type of presence measurement and the type of anxiety measurement. This meta-analysis confirms the positive relation between sense of presence and anxiety and demonstrates that this relation can be affected by various moderating factors.

Dataset Information

STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.

Publications

STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.

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