Virtual Reality Therapy for Emotional Regulation in Youth (VERVE Trial)
Palo Alto (17 mi)Overseen byRyan J Herringa, MD,PhD
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: University of Wisconsin, Madison
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial aims to test virtual reality video games as a way to help young people in the juvenile justice system manage their emotions. The games provide real-time feedback on the body's responses, teaching better emotional control. The goal is to see if this method is effective and well-received by the participants.
Is the treatment DEEP VR a promising treatment for emotional regulation in youth?Yes, DEEP VR is a promising treatment for emotional regulation in youth. Virtual reality therapy has shown benefits in reducing anxiety and depression, making it a valuable tool for helping young people manage their emotions. It is engaging and can be more accessible than traditional therapy methods.45678
What safety data exists for virtual reality therapy for emotional regulation in youth?The safety data for virtual reality therapy, including treatments like DEEP VR, shows that it is generally feasible, tolerable, and beneficial for treating anxiety in youth. Studies indicate that VR therapy can reduce anxiety severity and elicit changes in physiological and subjective outcomes. However, mild and temporary side effects such as nausea, dizziness, or headache can occur. The therapy is considered safe with proper therapist supervision and offers advantages like controlled exposure and confidentiality. Despite some methodological limitations in studies, VR therapy is seen as a promising alternative for emotional disorders.13468
Do I have to stop taking my current medications for this trial?The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, but you should confirm with the trial organizers.
What data supports the idea that Virtual Reality Therapy for Emotional Regulation in Youth is an effective treatment?The available research shows that Virtual Reality Therapy can be effective for treating anxiety and depression in youth. One study found that VR therapy was more effective than no treatment for reducing anxiety and depression symptoms. Another study showed that VR therapy was as effective as traditional therapy for social anxiety and was more practical for therapists. Additionally, VR therapy was found to enhance emotional engagement and treatment appreciation in children with aggressive behavior problems compared to traditional roleplays. These findings suggest that VR therapy can be a promising tool for emotional regulation in youth.24578
Eligibility Criteria
This trial is for youth aged 13-17 under juvenile justice supervision, who can read English and have a caregiver's consent. It's not for those with severe psychiatric conditions or discomfort with immersive experiences like VR.Inclusion Criteria
I can read text on a computer screen clearly.
I am between 13 and 17 years old.
Treatment Details
The study tests a virtual reality video game designed to help manage emotions in teens exposed to violence. Participants will undergo up to six sessions of the VR-based treatment called DEEP VR.
1Treatment groups
Experimental Treatment
Group I: DEEP VR Experiment GroupExperimental Treatment1 Intervention
Participants identified from the Dane County Juvenile Court Program will be asked to experience up to 6 VR-B sessions. Participants will wear a lightweight, ultra-high-resolution, wireless, head-mounted display (Oculus Quest 2 Enterprise VR Headset). Each session will proceed through a series of four stages. First, participants will begin with a 5 minute acclimation period inside a demo VR environment. Second, baseline levels of physiological arousal will be captured over a 5 minute resting period where participants will be asked to sit quietly in a serene virtual environment. Third, participants will progress through the DEEP VR experience for 15 minutes. Finally, participants will complete a short series of online questionnaires.
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of WisconsinMadison, WI
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Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
University of TorontoCollaborator
Radboud University Medical CenterCollaborator
Explore DEEP IncCollaborator
References
Isolating the effect of Virtual Reality Based Exposure Therapy for agoraphobia: a comparative trial. [2011]The isolated effect of Virtual Reality Based Exposure Therapy (VRBET) for agoraphobia was analyzed through a comparative trial involving the first 10 agoraphobic participants. The participants were randomly assigned to two groups: VREBT only and VREBT combined with cognitive therapy. All the required Virtual Environments (VE) were created with an inexpensive Game Level Editor (GLE). Outcome measures supported the immersive effect of the VEs. Questionnaires, behavioral tests and physiological measures indicated a positive effect of VRBET alone. The addition of cognitive therapy to VREBT did not appear to generate any significant differences. Consequences for future research and practice are discussed.
Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial. [2019]BackgroundPeople with social anxiety disorder (SAD) fear social interactions and may be reluctant to seek treatments involving exposure to social situations. Social exposure conducted in virtual reality (VR), embedded in individual cognitive-behavioural therapy (CBT), could be an answer.AimsTo show that conducting VR exposure in CBT for SAD is effective and is more practical for therapists than conducting exposure in vivoMethodParticipants were randomly assigned to either VR exposure (n = 17), in vivo exposure (n = 22) or waiting list (n = 20). Participants in the active arms received individual CBT for 14 weekly sessions and outcome was assessed with questionnaires and a behaviour avoidance test. (Trial registration number ISRCTN99747069)ResultsImprovements were found on the primary (Liebowitz Social Anxiety Scale) and all five secondary outcome measures in both CBT groups compared with the waiting list. Conducting exposure in VR was more effective at post-treatment than in vivo on the primary outcome measure and on one secondary measure. Improvements were maintained at the 6-month follow-up. VR was significantly more practical for therapists than in vivo exposure.ConclusionsUsing VR can be advantageous over standard CBT as a potential solution for treatment avoidance and as an efficient, cost-effective and practical medium of exposure.
[Virtual reality therapy in anxiety disorders]. [2017]During the last decade a number of studies have been conducted in order to examine if virtual reality exposure therapy can be an alternative form of therapy for the treatment of mental disorders and particularly for the treatment of anxiety disorders. Imaginal exposure therapy, which is one of the components of Cognitive Behavioral Therapy, cannot be easily applied to all patients and in cases like those virtual reality can be used as an alternative or a supportive psychotherapeutic technique. Most studies using virtual reality have focused on anxiety disorders, mainly in specific phobias, but some extend to other disorders such as eating disorders, drug dependence, pain control and palliative care and rehabilitation. Main characteristics of virtual reality therapy are: "interaction", "immersion", and "presence". High levels of "immersion" and "presence" are associated with increased response to exposure therapy in virtual environments, as well as better therapeutic outcomes and sustained therapeutic gains. Typical devices that are used in order patient's immersion to be achieved are the Head-Mounted Displays (HMD), which are only for individual use, and the computer automatic virtual environment (CAVE), which is a multiuser. Virtual reality therapy's disadvantages lie in the difficulties that arise due to the demanded specialized technology skills, devices' cost and side effects. Therapists' training is necessary in order for them to be able to manipulate the software and the hardware and to adjust it to each case's needs. Devices' cost is high but as technology continuously improves it constantly decreases. Immersion during virtual reality therapy can induce mild and temporary side effects such as nausea, dizziness or headache. Until today, however, experience shows that virtual reality offers several advantages. Patient's avoidance to be exposed in phobic stimuli is reduced via the use of virtual reality since the patient is exposed to them as many times as he wishes and under the supervision of the therapist. The technique takes place in the therapist's office which ensures confidentiality and privacy. The therapist is able to control unpredicted events that can occur during patient's exposure in real environments. Mainly the therapist can control the intensity of exposure and adapt it to the patient's needs. Virtual reality can be proven particularly useful in some specific psychological states. For instance, patients with post-traumatic stress disorder (PTSD) who prone to avoid the reminders of the traumatic events. Exposure in virtual reality can solve this problem providing to the patient a large number of stimuli that activate the senses causing the necessary physiological and psychological anxiety reactions, regardless of his willingness or ability to recall in his imagination the traumatic event.
The effectiveness of virtual reality based interventions for symptoms of anxiety and depression: A meta-analysis. [2019]We report a meta-analysis of virtual reality (VR) interventions for anxiety and depression outcomes, as well as treatment attrition. We included randomized controlled trials comparing VR interventions, alone or in combination, to control conditions or other active psychological interventions. Effects sizes (Hedges' g) for anxiety and depression outcomes, as post-test and follow-up, were pooled with a random-effects model. Drop-outs were compared using odds ratio (OR) with a Mantel-Haenszel model. We included 39 trials (52 comparisons). Trial risk of bias was unclear for most domains, and high for incomplete outcome data. VR-based therapies were more effective than control at post-test for anxiety, g = 0.79, 95% CI 0.57 to 1.02, and depression, g = 0.73, 95% CI 0.25 to 1.21, but not for treatment attrition, OR = 1.34, 95% CI 0.95 to 1.89. Heterogeneity was high and there was consistent evidence of small study effects. There were no significant differences between VR-based and other active interventions. VR interventions outperformed control conditions for anxiety and depression but did not improve treatment drop-out. High heterogeneity, potential publication bias, predominant use of waitlist controls, and high or uncertain risk of bias of most trials question the reliability of these effects.
The use of virtual reality in assessment and treatment of anxiety and related disorders. [2021]In recent years the development of new virtual environments has been qualitatively high and fast at the same time, but the dissemination of virtual reality (VR) in clinical practice is still scarce. The aim of this review is to give an insight into the state of the art of the use of VR as an assessment tool and treatment intervention in anxiety and related disorders as posttraumatic stress disorder and obsessive-compulsive disorders. Besides an overview into the efficacy of VR, a summary will be given on assumed working mechanisms in virtual reality exposure therapy and how this aligns with current theoretical models. Further, it will be discussed how VR is accepted by patients and research into the reluctance of therapist to use this technology during treatment with focus on the therapeutic alliance and how it may be influenced by the use of VR. Finally, we discuss clinical and future issues as, for example, dissemination into clinical practice and what VR has to offer therapists in future. This not only in adult population but as well in younger patients, as young adolescents VR has a great potential as it connects easily with its playful elements to this population and might be a low threshold step to offer treatment or preventive interventions.
A Decade in Review: A Systematic Review of Virtual Reality Interventions for Emotional Disorders. [2023]Research is increasingly demonstrating the therapeutic benefits of virtual reality interventions for various mental health conditions, though these rarely translate from research to application in clinical settings. This systematic review aims to examine the efficacy of current virtual reality interventions for emotional disorders, with a focus on clinical and technological features that influence translation of treatments from research to clinical practice. A comprehensive systematic literature search was conducted following PRISMA guidelines, for studies including the application of a virtual reality intervention to a clinical population of adults with an emotional disorder. Thirty-seven eligible studies were identified, appraised, and assessed for bias. Treatment effects were typically large across studies, with virtual reality being considered an efficacious treatment modality for various anxiety disorders and post-traumatic stress disorder. Virtual reality interventions were typically used for delivering exposure in cognitive behavioural therapy approaches. Considerable variability was seen in cost, technological specifications, degree of therapist involvement, delivery format, dosage, duration, and frequency of treatment. Suboptimal methodological rigour was identified in some studies. Remote use of virtual reality was rare, despite increasing options for in home use. Virtual reality interventions have the potential to overcome barriers to care and better meet the needs of consumers. Future research should examine the efficacy of virtual reality for treatment of depressive disorders and obsesive compulsive disorder. Improved methodological reporting and development of transdiagnostic and remotely delivered virtual reality interventions, will likely increase the translation of this treatment modality.
Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. [2023]This multicenter randomized controlled trial investigated whether interactive virtual reality enhanced effectiveness of Cognitive Behavioral Therapy (CBT) to reduce children's aggressive behavior problems. Boys with aggressive behavior problems (N = 115; Mage  = 10.58, SD = 1.48; 95.7% born in Netherlands) were randomized into three groups: CBT with virtual reality, CBT with roleplays, or care-as-usual. Bayesian analyses showed that CBT with virtual reality more likely reduced aggressive behavior compared to care-as-usual for six of seven outcomes (ds 0.19-0.95), and compared to CBT with roleplays for four outcomes (ds 0.14-0.68). Moreover, compared to roleplays, virtual reality more likely enhanced children's emotional engagement, practice immersion, and treatment appreciation. Thus, virtual reality may be a promising tool to enhance CBT effectiveness for children with aggressive behavior problems.
Immersive Virtual Reality Exposures for the Treatment of Childhood Anxiety. [2023]Exposure-based cognitive behavior therapy (CBT) has demonstrated efficacy and is recommended as a front-line treatment for childhood anxiety. Unfortunately, challenges exist that impact the effective implementation of exposure-based CBT in clinical practice. One of the primary challenges is the accessibility and availability of exposure stimuli (e.g., spiders, storms, heights) in CBT sessions. Immersive virtual reality (VR) has shown promise as a scalable and sustainable solution to address this clinical need, but remains largely untested in youth with anxiety disorders. Here, we examine the use of VR exposures in the treatment of youth with an anxiety disorder (i.e., specific phobias). We aimed to investigate: (1) the feasibility and clinical benefit of VR exposures; (2) whether VR exposures elicit changes in physiological arousal and/or subjective distress; and (3) whether habituation serves as a mechanism across physiological and subjective outcomes for VR exposures. Three youth and their parents completed a clinical evaluation, which was followed by a one session treatment (OST) with VR exposures. Afterward, youth and parents completed clinical assessments one-week and 1-month after treatment. Immersive VR exposures were found to be feasible and demonstrated clinical benefit for reducing anxiety severity. Additionally, VR exposures elicited changes in both physiological and subjective outcomes. Finally, physiological habituation to VR exposures was observed among participants who exhibited treatment response at follow-up. Collectively, these findings demonstrate preliminary evidence that VR exposures are feasible, tolerable, and show some therapeutic benefit for treating youth with anxiety.