Virtual Reality Exposure Therapy for Public Speaking Anxiety (VRETA)

• ClinicalTrials.gov Identifier: NCT03885414
• Recruitment Status: Completed
• First Posted: March 21, 2019
• Last Update Posted: January 23, 2020
• Sponsor: Stockholm University
• Collaborators: PBM; Mimerse
• Information provided by (Responsible Party): Per Carlbring, Stockholm University

Tracking Information

• First Submitted Date: March 11, 2019
• First Posted Date: March 21, 2019
• Last Update Posted Date: January 23, 2020
• Actual Study Start Date: January 14, 2019
• Actual Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 19, 2019)

Change from baseline: Public Speaking Anxiety Scale [ Time Frame: 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 ]

Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay & Houlihan, 2016)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 19, 2019)

• Change from baseline: Brunnsviken Brief Quality of life scale [ Time Frame: Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST ]
  Canonical total score will be used. Measure is self-rated, online.
• Change from baseline: Liebowitz Social Anxiety Scale Self-Report [ Time Frame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST ]
  Canonical total score will be used. Measure is self-rated, online.
• Change from baseline: Brief Fear of Negative Evaluation Scale [ Time Frame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST ]
  Canonical total score will be used. Measure is self-rated, online.
• Change from baseline: Patient Health Questionnaire 9-item [ Time Frame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST ]
  Canonical total score will be used. Measure is self-rated, online.
• Change from baseline: Generalized Anxiety Disorder 7-item [ Time Frame: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST ]
  Canonical total score will be used. Measure is self-rated, online.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Virtual Reality Exposure Therapy for Public Speaking Anxiety
• Official Title: Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Multiple baseline

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• 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.
  Other Names:

  • Virtual reality therapy
  • Exposure therapy
  • Cognitive behavioral therapy
• Behavioral: Internet-administered transition program
  Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.
  Other Name: Internet intervention

Study Arms

Experimental: OST-VRET + in-vivo transition program

One-session treatment (OST) VRET on-location with clinical psychologist (3 hours), followed by a therapist-guided, four-week online program encouraging transition to real-world, in-vivo exposure exercises.

Interventions:

• Behavioral: In-session Virtual Reality exposure therapy
• Behavioral: Internet-administered transition program

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 22, 2020): 23
• Original Estimated Enrollment (submitted: March 19, 2019): 25
• Actual Study Completion Date: September 30, 2019
• Actual Primary Completion Date: September 30, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT03885414
• Other Study ID Numbers: VRETA
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided
• Plan Description: Anonymous outcome measure IPD will be made available upon request from academic researchers.

• Responsible Party: Per Carlbring, Stockholm University
• Study Sponsor: Stockholm University

Collaborators

• PBM
• Mimerse

Investigators

• Principal Investigator: Per Carlbring, PhD; Stockholm University

• PRS Account: Stockholm University
• Verification Date: January 2020