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Virtual Reality Exposure Therapy for Public Speaking Anxiety (VRETA)

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

Tracking Information
First Submitted Date  ICMJE March 11, 2019
First Posted Date  ICMJE March 21, 2019
Last Update Posted Date January 23, 2020
Actual Study Start Date  ICMJE January 14, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality Exposure Therapy for Public Speaking Anxiety
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Multiple baseline
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Public Speaking
  • Social Anxiety
  • Social Anxiety Disorder, Performance Only
Intervention  ICMJE
  • 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  ICMJE 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2020)
23
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
25
Actual Study Completion Date  ICMJE September 30, 2019
Actual Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885414
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Stockholm University
Collaborators  ICMJE
  • PBM
  • Mimerse
Investigators  ICMJE
Principal Investigator: Per Carlbring, PhD Stockholm University
PRS Account Stockholm University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP