Virtual Reality Exposure Therapy for Public Speaking Anxiety

Social Anxiety Clinical Trial

— VRETA  

Official title:

Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885414
• Other study ID #: VRETA
• Status: Completed
• Phase: N/A
• Start date: January 14, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: Stockholm University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Public Speaking
• Social Anxiety
• Social Anxiety Disorder, Performance Only

Intervention

Behavioral:
• In-session Virtual Reality exposure therapy
A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.
• Internet-administered transition program
Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.

Locations

Country	Name	City	State
Sweden	Department of Psychology	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Stockholm University	Mimerse, PBM

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Lindner P, Miloff A, Fagernäs 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. Erratum in: J Anxiety Disord. 2019 May;64:90. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline: Public Speaking Anxiety Scale	Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay & Houlihan, 2016)	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	Change from baseline: Brunnsviken Brief Quality of life scale	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST
Secondary	Change from baseline: Liebowitz Social Anxiety Scale Self-Report	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Secondary	Change from baseline: Brief Fear of Negative Evaluation Scale	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Secondary	Change from baseline: Patient Health Questionnaire 9-item	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Secondary	Change from baseline: Generalized Anxiety Disorder 7-item	Canonical total score will be used. Measure is self-rated, online.	Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST

External Links

•   Study website (Swedish)