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OpenTrials
Completed

NCT Number: NCT03885414

Virtual Reality Exposure Therapy for Public Speaking Anxiety

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychology

Stockholm, 10691, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-session Virtual Reality exposure therapy

Behavioral

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

Internet-administered transition program

Behavioral

Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.

Other names: Internet intervention

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Stockholm University

Other

Collaborators

  • Mimerse
  • PBM

Registry information

Official study title

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

Acronym: VRETA

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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