Virtual Reality Therapy for ADHD
Palo Alto (17 mi)Overseen bySusan Persky, Ph.D.
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: National Human Genome Research Institute (NHGRI)
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests if virtual reality games can help children with ADHD improve their thinking skills and brain function. Participants will play these games to practice focusing, controlling impulses, processing information quickly, and remembering things better. The goal is to see if these games can make a positive difference in their daily lives.
Is the Floreo Virtual Reality application a promising treatment for ADHD?Yes, the Floreo Virtual Reality application is a promising treatment for ADHD. It uses virtual reality to create engaging environments that help improve attention and reduce hyperactivity and impulsiveness in children with ADHD. The technology is well-accepted and flexible, making it a fun and effective way to support children with ADHD.1691112
Do I have to stop taking my current ADHD medications for the trial?Yes, if you are treated with psychostimulants for ADHD, you must stop taking them three days before the baseline assessments and stay off them until the post-intervention assessment is completed. You also cannot be on any other psychotropic medication for at least 30 days before the baseline assessment.
What safety data exists for Virtual Reality Therapy for ADHD?The provided research does not directly address safety data for Virtual Reality Therapy for ADHD or the specific Floreo VR applications. However, it includes studies on the effectiveness and usability of VR therapy for other conditions like social anxiety disorder, specific phobias, and gait rehabilitation. These studies suggest VR therapy is generally effective and well-accepted, but they do not provide specific safety data for ADHD or the Floreo VR applications.245810
What data supports the idea that Virtual Reality Therapy for ADHD is an effective treatment?The available research shows that Virtual Reality Therapy for ADHD, like the IAmHero tool, has shown promising results. In a study involving children with ADHD, improvements were observed in symptoms such as hyperactivity and impulsivity, as well as in executive functions, after using VR therapy for about six months. This suggests that VR therapy can be an effective treatment for ADHD, offering benefits in managing symptoms and improving cognitive functions. Additionally, the VR approach is well-accepted and flexible, making it a favorable option compared to traditional treatments.1371112
Eligibility Criteria
This trial is for children aged 7 to 14 with ADHD, who can follow the study's procedures and are stable on medication if they're taking any. It excludes those with cognitive impairments, severe migraines, vertigo, epilepsy or serious balance disorders, poor uncorrected vision, pregnancy, psychotic disorders or substance dependence.Treatment Details
The trial tests a virtual reality-based game using Floreo VR applications designed to improve attention and cognitive skills in kids with ADHD. Participants play games that target specific skills like inhibition control for several weeks while their brain function is monitored.
1Treatment groups
Experimental Treatment
Group I: Floreo VR groupExperimental Treatment1 Intervention
This group will undergo up to 20 daily sessions (20 minutes each) of the Floreo VR training.
Find a clinic near you
Research locations nearbySelect from list below to view details:
National Institutes of Health Clinical CenterBethesda, MD
Loading ...
Who is running the clinical trial?
National Human Genome Research Institute (NHGRI)Lead Sponsor
References
Psychiatric therapeutic applications of virtual reality technology (VRT): research prospectus and phenomenological critique. [2005]There is theoretical and empirical research supporting the hypothesis that virtual reality technology (VRT) can be efficaciously applied to attenuate the symptoms of mental disorders (Baer, 1996; Rothbaum et al, 1995a, 1995b; Rothbaum et al, 1996.) Yet there is also research suggesting psychiatric therapeutic applications of VRT may induce noxious or unexpected psychological consequences (Kolasinski, 1996; Muscott & Gifford, 1994; Regan & Price, 1994; Regan & Ramsey, 1996; Strickland, 1995.) A prudent conclusion would be to advocate ever more sophisticated studies on psychiatric therapeutic applications of VRT concerning (1) increasing the overall socioadaptiveness of patients, (2) the robustness of moderating, modifying, or other intermediary variables effecting or affecting VRT therapeutic efficacy, and (3) variables, processes, and hypotheses generated from VRT applications in non-psychiatric fields.
Using virtual humans to alleviate social anxiety: preliminary report from a comparative outcome study. [2019]Empirical studies have consistently shown the effectiveness of a multicomponent CBT treatment of social anxiety disorder (SAD). Previous outcome studies on virtual reality and SAD have focused on people suffering from fear of public speaking and not full blown SAD. In this study, 45 adults receiving a DSM-IV-TR diagnostic of social anxiety were randomly assigned to traditional CBT treatment (with in vivo exposure), CBT-VR combined treatment, or a waiting list. Results show significant reduction of anxiety on all questionnaires as well as statistically significant interactions between both treatment groups and the waiting list.
Low-cost virtual reality intervention program for children with developmental coordination disorder: a pilot feasibility study. [2015]To explore the feasibility of using a low-cost, off-the-shelf virtual reality (VR) game to treat young children with developmental coordination disorder (DCD) and to determine the effect of this intervention on motor function.
Can virtual reality exposure therapy gains be generalized to real-life? A meta-analysis of studies applying behavioral assessments. [2018]In virtual reality exposure therapy (VRET), patients are exposed to virtual environments that resemble feared real-life situations. The aim of the current study was to assess the extent to which VRET gains can be observed in real-life situations. We conducted a meta-analysis of clinical trials applying VRET to specific phobias and measuring treatment outcome by means of behavioral laboratory tests or recordings of behavioral activities in real-life. Data sources were searches of databases (Medline, PsycInfo, and Cochrane). We included in total 14 clinical trials on specific phobias. Results revealed that patients undergoing VRET did significantly better on behavioral assessments following treatment than before treatment, with an aggregated uncontrolled effect size of g = 1.23. Furthermore, patients undergoing VRET performed better on behavioral assessments at post-treatment than patients on wait-list (g = 1.41). Additionally, results of behavioral assessment at post-treatment and at follow-up revealed no significant differences between VRET and exposure in vivo (g = -0.09 and 0.53, respectively). Finally, behavioral measurement effect sizes were similar to those calculated from self-report measures. The findings demonstrate that VRET can produce significant behavior change in real-life situations and support its application in treating specific phobias.
Single-session gamified virtual reality exposure therapy for spider phobia vs. traditional exposure therapy: study protocol for a randomized controlled non-inferiority trial. [2019]Traditional one-session exposure therapy (OST) in which a patient is gradually exposed to feared stimuli for up to 3 h in a one-session format has been found effective for the treatment of specific phobias. However, many individuals with specific phobia are reluctant to seek help, and access to care is lacking due to logistic challenges of accessing, collecting, storing, and/or maintaining stimuli. Virtual reality (VR) exposure therapy may improve upon existing techniques by facilitating access, decreasing cost, and increasing acceptability and effectiveness. The aim of this study is to compare traditional OST with in vivo spiders and a human therapist with a newly developed single-session gamified VR exposure therapy application with modern VR hardware, virtual spiders, and a virtual therapist.
Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study. [2023]Advances in virtual reality (VR) technology offer new opportunities to design supports for the core behaviors associated with autism spectrum disorder (ASD) that promote progress toward optimal outcomes. Floreo has developed a novel mobile VR platform that pairs a user receiving instruction on target skills with an adult monitor.
Promoting Emotional Well-being in Hospitalized Children and Adolescents With Virtual Reality: Usability and Acceptability of a Randomized Controlled Trial. [2021]The aim of this study was to describe and compare small-sized preliminary data on the usability and acceptability of a randomized controlled trial. This study compares a one-to-one cognitive-behavioral treatment and a virtual reality treatment for children and adolescents hospitalized for long-term physical conditions. The final sample was composed of 19 children and adolescents with chronic illness who were hospitalized. The sample was randomly allocated to two intervention groups: cognitive-behavioral usual treatment and virtual reality-based treatment. Participants in the virtual reality group demonstrated higher perceived efficacy scores for every treatment component than for traditional treatment. Statistically significant differences were found for the total usability and acceptability scores. Participants in the virtual reality group show high acceptability of all the virtual environments. The components and environments of virtual reality were well accepted. The virtual reality program received high scores in immersion, feasibility of use, and sense of reality. Technology-based treatments, that is, virtual reality, can provide motivational benefits in relation to traditional treatments.
Immersive virtual reality during gait rehabilitation increases walking speed and motivation: a usability evaluation with healthy participants and patients with multiple sclerosis and stroke. [2021]The rehabilitation of gait disorders in patients with multiple sclerosis (MS) and stroke is often based on conventional treadmill training. Virtual reality (VR)-based treadmill training can increase motivation and improve therapy outcomes. The present study evaluated an immersive virtual reality application (using a head-mounted display, HMD) for gait rehabilitation with patients to (1) demonstrate its feasibility and acceptance and to (2) compare its short-term effects to a semi-immersive presentation (using a monitor) and a conventional treadmill training without VR to assess the usability of both systems and estimate the effects on walking speed and motivation.
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.
Cognitive behavioral therapy with adaptive virtual reality exposure vs. cognitive behavioral therapy with in vivo exposure in the treatment of social anxiety disorder: A study protocol for a randomized controlled trial. [2022]Social anxiety disorder (SAD) has a high prevalence and an early onset with recovery taking decades to occur. Current evidence supports the efficacy of cognitive behavioral therapy (CBT) with virtual reality (VR) exposure. However, the evidence is based on a sparse number of studies with predominantly small sample sizes. There is a need for more trials investigating the optimal way of applying VR based exposure for SAD. In this trial, we will test the efficacy of CBT with adaptive VR exposure allowing adjustment of the exposure based on real-time monitoring of the participants's anxiety level.
An immersive virtual reality-based application for treating ADHD: A remote evaluation of acceptance and usability. [2022]Virtual reality (VR) is a digital technology currently considered to implement rehabilitation programs for children with ADHD, a disorder characterised by inattention, overactivity and impulsiveness. This study presents the results of the acceptance and usability of a VR application developed for children with ADHD aiming to provide an environment capable of supporting the development of the different attentional components. Due to COVID-19 restrictions, this study had the secondary aim of assessing whether a remote evaluation was feasible and meaningful.
IAmHero: Preliminary Findings of an Experimental Study to Evaluate the Statistical Significance of an Intervention for ADHD Conducted through the Use of Serious Games in Virtual Reality. [2023]The use of new technologies, such as virtual reality (VR), represents a promising strategy in the rehabilitation of subjects with attention-deficit/hyperactivity disorder (ADHD). We present the results obtained by administering the IAmHero tool through VR to a cohort of subjects with ADHD between 5 and 12 years of age. The trial time was approximately 6 months. In order to assess the beneficial effects of the treatment, standardised tests assessing both ADHD symptoms and executive functions (e.g., Conners-3 scales) were administered both before and at the end of the sessions. Improvements were observed at the end of treatment in both ADHD symptoms (especially in the hyperactivity/impulsivity domain) and executive functions. One of the strengths of the VR approach is related above all to the acceptability of this tool and its flexibility. Unfortunately, to date, there are still few studies on this topic; therefore, future studies are essential to expand our knowledge on the utility and benefits of these technologies in the rehabilitation field.