Anxiety Clinical Trial
— VRETORIKOfficial title:
Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
NCT number | NCT03001154 |
Other study ID # | VRetorik |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 1, 2017 |
Est. completion date | June 2018 |
Verified date | March 2019 |
Source | Stockholm University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2018 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Substantial public speaking anxiety - Have access to VR-compatible smartphone (including Internet) - Can travel to Stockholm University for treatment on one occasion - Can speak and understand sufficient Swedish Exclusion Criteria: - Deficits in sight or balance impacting the VR-experience - A severe psychiatric disorder better treated elsewhere, including current major depression, alcohol or drug abuse, bipolarity, psychosis or similar - Active psychopharmacological treatment, unless stable for last 3 months - Other ongoing psychological treatment |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Psychology | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Stockholm University |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Public Speaking Anxiety Scale | Self-rating of public speaking anxiety | Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21 | |
Secondary | Liebowitz Social Anxiety Scale Self-Report | Self-rating of general social anxiety | Change from baseline: Week 0, 5 and 21 | |
Secondary | Brief Fear of Negative Evaluation Scale | Self-rating of fear of negative evaluation | Change from baseline: Week 0, 5 and 21 | |
Secondary | Patient Health Questionnaire 9-item | Self-rating of depressive symptoms | Change from baseline: Week 0, 5 and 21 | |
Secondary | Generalized Anxiety Disorder 7-item | Self-rating of general anxiety symptoms | Change from baseline: Week 0, 5 and 21 | |
Secondary | Brunnsviken Brief Quality of life scale | Self-rating of quality of life | Change from baseline: Week 0, 5 and 21 |
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