Clinical trial NCT03885414: Virtual Reality Exposure Therapy for Public Speaking Anxiety
Official title: Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Public Speaking
Social Anxiety
Social Anxiety Disorder, Performance Only
Lead sponsor: Stockholm University
Sponsor class: OTHER
Collaborators: name: PBM
name: Mimerse
First posted: 2019-03-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multiple baseline
Primary purpose: TREATMENT

Brief summary: Virtual Reality exposure therapy (VRET) is an efficacious treatment for anxiety disorders but has yet to be implemented in regular care settings. This is arguably due to the limitations of the past generation of VR technology, which was expensive, inaccessible, cumbersome and hard to use. With the advent of consumer VR technology, VRET is now ready for implementation in regular care. This multiple-baseline trial will examine the effectiveness of VRET for public speaking anxiety (PSA) when delivered under real-world conditions at an ordinary, non-specialized mental health clinic, by clinical psychologist with only brief VRET training. Participants will either be self-referred specifically for this treatment, or come through ordinary clinical channels. Self-rated PSA will serve as primary outcome measure and will be measured three times prior to treatment (at screening and twice after a diagnostic screening telephone interview) , four times after onset, at the end of the treatment period, and three months after treatment.


Eligibility criteria: Inclusion Criteria:

* Have substantial public speaking anxiety (PSAS \>= 60)
* Can travel to PBM clinic on one occasion and pay stipulated patient fee
* Can speak and understand sufficient Swedish
* Have stable access to the internet

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

Primary outcomes:
measure: Change from baseline: Public Speaking Anxiety Scale
timeFrame: Change from baseline: (1) five days after interview, (2) ten days after interview, (3) 7 days post-OST, (4) 14 days post-OST (5) 21 days post-OST (6) 28 days post-OST, (7) 35 days post-OST, (8) 125 days post-PST
Secondary outcomes:
measure: Change from baseline: Brunnsviken Brief Quality of life scale
timeFrame: Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST
measure: Change from baseline: Liebowitz Social Anxiety Scale Self-Report
timeFrame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
measure: Change from baseline: Brief Fear of Negative Evaluation Scale
timeFrame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
measure: Change from baseline: Patient Health Questionnaire 9-item
timeFrame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
measure: Change from baseline: Generalized Anxiety Disorder 7-item
timeFrame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Psychology
Study officials:
affiliation: Stockholm University
name: Per Carlbring, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindner P, Miloff A, Fagernas S, Andersen J, Sigeman M, Andersson G, Furmark T, Carlbring P. Therapist-led and self-led one-session virtual reality exposure therapy for public speaking anxiety with consumer hardware and software: A randomized controlled trial. J Anxiety Disord. 2019 Jan;61:45-54. doi: 10.1016/j.janxdis.2018.07.003. Epub 2018 Jul 24.