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Virtual Reality Exposure Therapy for Public Speaking Anxiety (VRETA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Public Speaking Social Anxiety Social Anxiety Disorder, Performance Only Behavioral: In-session Virtual Reality exposure therapy Behavioral: Internet-administered transition program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multiple baseline
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885414


Locations
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Sweden
Department of Psychology
Stockholm, Sweden, 10691
Sponsors and Collaborators
Stockholm University
PBM
Mimerse
Investigators
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Principal Investigator: Per Carlbring, PhD Stockholm University
Additional Information:
Publications:
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Responsible Party: Per Carlbring, Professor, Stockholm University
ClinicalTrials.gov Identifier: NCT03885414    
Other Study ID Numbers: VRETA
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymous outcome measure IPD will be made available upon request from academic researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Phobia, Social
Mental Disorders
Phobic Disorders