Pico Goblin VR headset for Anxiety Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The Pennsylvania State University, University Park, PA
Anxiety Disorders+2 More
Pico Goblin VR headset - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether virtual reality exposure therapy may help individuals with social anxiety disorder.

See full description

Eligible Conditions

  • Anxiety Disorders
  • Social Anxiety Disorder (SAD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pico Goblin VR headset will improve 6 primary outcomes, 6 secondary outcomes, and 3 other outcomes in patients with Anxiety Disorders. Measurement will happen over the course of Baseline, 2-8-week-post-randomization.

2-8-week-post-randomization
Treatment acceptability
Baseline
Mental health disorder screening measures
Baseline, 2-8-week-post-randomization
Change from Baseline Depression Symptom Severity at 2-8-week-post-randomization
Change from Baseline Job Interview Anxiety at 2-8-week-post-randomization
Change from Baseline Social Anxiety Disorder at 2-8-week-post-randomization
Change from Baseline Trait Worry Symptom Severity at 2-8-week-post-randomization
Process measures
Baseline, 3-month post-randomization
Change from Baseline Job Interview Anxiety at 3-month post-randomization
Baseline, 3-month-post-randomization
Change from Baseline Depression Symptom Severity at 3-month-post-randomization
Change from Baseline Social Anxiety Disorder at 3-month post-randomization
Change from Baseline Trait Worry Symptom Severity at 3-month-post-randomization
Baseline, 6-month post-randomization
Change from Baseline Job Interview Anxiety at 6-month post-randomization
Baseline, 6-month-post-randomization
Change from Baseline Depression Symptom Severity at 6-month-post-randomization
Change from Baseline Social Anxiety Disorder at 6-month post-randomization
Change from Baseline Trait Worry Symptom Severity at 6-month-post-randomization

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Waiting list
1 of 2
Virtual reality exposure therapy
1 of 2
Active Control
Experimental Treatment

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pico Goblin VR Headset is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Virtual reality exposure therapy
Device
Participants were allowed to choose one of two themes. For both themes, each scene was developed to be more anxiety-provoking as the VRE progressed. Greater anxiety-inducing scenes had interviewers and other actors who displayed less compassionate, friendly, humorous, and pleasant verbal and non-verbal behaviors and demeanors to elicit elevated anxiety (Carless & Imber, 2007). Also, a virtual therapist was embedded within the VRE. It functioned to coach the participant through each distinct scene by orienting and prompting them to the exposure therapy task(s), continually conveying core principles of exposure therapy, and repeating the instructions if the participant was not responsive within five seconds. Each scene started with a paused video, during which participants were oriented by the virtual therapist to the context.
Waiting listParticipants started treatment 2-4 weeks post-randomization.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 6-month-post-randomization
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 6-month-post-randomization for reporting.

Who is running the study

Principal Investigator
M. G. N.
Prof. Michelle G. Newman, Professor of Psychology
Penn State University

Closest Location

The Pennsylvania State University - University Park, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Presence of Social Anxiety Disorder based on the Social Phobia Diagnostic Questionnaire self-report or Mini International Neuropsychiatric Interview
Current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate through the PSU StudyFinder portal
Expressed interest to seek treatment
Currently not receiving treatment from a mental health professional
Able to provide consent
Proficient in English

Patient Q&A Section

What is anxiety disorders?

"Among many conditions, anxiety disorders often co-occur with some physical disorders in clinical populations. If anxiety comorbid with physical disorders do exist, clinical presentation may be different from those in a DSM-III setting. A clearer phenomenological context may be of help in understanding and diagnosing anxiety in clinical practice." - Anonymous Online Contributor

Unverified Answer

Can anxiety disorders be cured?

"Anxiety disorders are best managed with cognitive behavioral psychotherapy, pharmacotherapy and a combination of the two. There are no reliable evidence-based guidelines for the use of SSRI pharmacotherapy for anxiety disorders." - Anonymous Online Contributor

Unverified Answer

How many people get anxiety disorders a year in the United States?

"Approximately 16.3 million people per year are diagnosed with either lifetime or current anxiety and 8.6 million people per year suffer from a specific anxiety disorder." - Anonymous Online Contributor

Unverified Answer

What are the signs of anxiety disorders?

"In a recent study, findings illustrate that the degree of anxiety disorder is a unique factor that is influenced by the underlying predisposition. Nevertheless, if the degree of anxiety is moderate with other symptoms of anxiety (tension, feelings of being tense, nervousness) and its symptoms persists through daily activities, then it is possible that this patient has a serious anxiety disorder. However, if anxiety is absent in the patient and the symptoms persist during the daily activities, then the patient is probably not having a serious anxiety disorder. It is important that every hospital and healthcare professional be aware of the various signs and symptoms of the different and serious anxiety disorders and not ignore them for fear of missing the serious condition of the patient." - Anonymous Online Contributor

Unverified Answer

What are common treatments for anxiety disorders?

"Approximately 45% of patients with co-occurring anxiety and substance abuse disorders receive psychoactive substance therapy. Patients with subthreshold mood disorders, or the absence of comorbid conditions, are less likely to receive such treatment. The impact of this disparity on the treatment of comorbid disorders requires further research." - Anonymous Online Contributor

Unverified Answer

What causes anxiety disorders?

"Anxiety disorders are common and treatable. Anxiety disorders appear to result from problems with a number of systems in the brain, including problems with the amygdala, hippocampus, and prefrontal cortex, while in the brain's more recent evolution they are more closely associated with the amygdala. Most anxiety disorders are linked to a complex and prolonged history of stressful, traumatic events. Although they can result from a multitude of factors, the most significant stressors can and do appear to be in the early stage of life. Understanding which stressful events are the most stressful for each individual can be an important tool for improving the ability of people to cope more effectively in the long term." - Anonymous Online Contributor

Unverified Answer

Is pico goblin vr headset typically used in combination with any other treatments?

"Many different combination treatments have been used with Pico Goblin. The effectiveness is unclear. The strongest evidence for a reduction in fatigue is in combination therapy with massage. This has not been conclusive and further studies are necessary." - Anonymous Online Contributor

Unverified Answer

What is the latest research for anxiety disorders?

"There is emerging evidence for the efficacy of Cognitive therapy with panic disorder (CT-P) for treating panic disorder. Although randomized trials are needed to confirm the efficacy of CT-P for treating GAD and social anxiety disorder (SAD), there were two studies that investigated the efficacy of CT-P for children. These two studies demonstrated that children and young adults who received 12 sessions of CT-P showed an improvement in panic symptoms compared to children and young adults in both CT-P group and waitlist controls. Further research is needed to see if the efficacy of CT-P would also improve in children or young adults who are older than or younger than 11 years." - Anonymous Online Contributor

Unverified Answer

Is pico goblin vr headset safe for people?

"The study found pico goblin VR is a safe technology. It is relatively inexpensive, and is easy to use under the conditions of our study. Although there were limitations to the study, it suggests pico goblin VR may provide a convenient and effective approach to treating patients with OCD in community settings or with a limited number of therapists. However, further controlled studies on larger samples are warranted." - Anonymous Online Contributor

Unverified Answer

How does pico goblin vr headset work?

"Based on the results, the pico goblin vr headset has the best usability among the three systems. The immersive experience of VR and the low cost of the product allow the pico goblin vr headset to be used by most customers." - Anonymous Online Contributor

Unverified Answer

Does pico goblin vr headset improve quality of life for those with anxiety disorders?

"The Pico Goblin VR headset has provided a more holistic and less stigmatized avenue for treatment for those with anxiety disorders by lowering distress and enhancing recovery. Anxiety is often viewed as an undesirable characteristic in a healthy individual, but in those with anxiety the desire to experience joy and happiness is often lost." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pico goblin vr headset?

"The reported antidepressant efficacy of the Goblin vr headset is in line with current evidence. Due to the shortcomings in the trial design reported, the Goblin vr headset cannot be recommended as a treatment for depression." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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