ClinicalTrials.gg
CompletedNCT03001154VRETORIKUpdated Mar 7, 2019

Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software

An interventional study of Face-to-face Virtual Reality Exposure Therapy and Internet-administered Virtual Reality Exposure Therapy in Social Phobia, Anxiety and Behavior Therapy, sponsored by Stockholm University. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.

Sponsored by Stockholm University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Virtual Reality Exposure Therapy (VRET) is an efficacious treatment of fear and anxiety, but because of the high financial costs and technical complexity of the past generation of VR hardware, there has been no large-scale implementation of this promising treatment. The present study will investigate whether off-the-shelf, commercial VR hardware and software can be used as stimuli material to conduct in-session exposure therapy for speech anxiety. The study will recruit n=25+25 participants from the general public suffering from substantial speech anxiety, who will be randomized to either a waiting-list, or one-session VRET with a therapist, followed by four weeks of a progressive maintenance program encouraging in-vivo exposure. The waiting-list group will then receive an Internet-delivered VRET treatment program.

02

Conditions studied

  • Social Phobia
  • Anxiety
  • Behavior Therapy
03

In context

Phobia, Social

353 studies on the registry are indexed under Phobia, Social; 58 are open to participants now.

This study's enrollment of 50 is below the median of 77 across 325 interventional studies indexed under Phobia, Social.

Browse Phobia, Social studies →

Lead sponsor

Stockholm University is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Substantial public speaking anxiety
  • Have access to VR-compatible smartphone (including Internet)
  • Can travel to Stockholm University for treatment on one occasion
  • Can speak and understand sufficient Swedish

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    One-session VRET face-to-face

    One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program.

    Behavioral: Face-to-face Virtual Reality Exposure Therapy

  • Experimental
    Waiting-list, then Internet-administered VRET

    4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program.

    Behavioral: Internet-administered Virtual Reality Exposure Therapy · Other: Waiting-list

Interventions

  • BehavioralFace-to-face Virtual Reality Exposure Therapy

    In session, systematic, hierarchical exposure to feared stimuli with therapist.

  • BehavioralInternet-administered Virtual Reality Exposure Therapy

    Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program

  • OtherWaiting-list

    Weekly assessments of public speaking

06

What researchers measure

Primary outcomes

  1. Public Speaking Anxiety Scale

    Self-rating of public speaking anxiety

    Time frame: Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21

Secondary outcomes

  1. Liebowitz Social Anxiety Scale Self-Report

    Self-rating of general social anxiety

    Time frame: Change from baseline: Week 0, 5 and 21

  2. Brief Fear of Negative Evaluation Scale

    Self-rating of fear of negative evaluation

    Time frame: Change from baseline: Week 0, 5 and 21

  3. Patient Health Questionnaire 9-item

    Self-rating of depressive symptoms

    Time frame: Change from baseline: Week 0, 5 and 21

  4. Generalized Anxiety Disorder 7-item

    Self-rating of general anxiety symptoms

    Time frame: Change from baseline: Week 0, 5 and 21

  5. Brunnsviken Brief Quality of life scale

    Self-rating of quality of life

    Time frame: Change from baseline: Week 0, 5 and 21

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Study locations

1 site
  • Department of Psychology
    Stockholm, 10691, Sweden
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in May 2017, 4 months.

Of 140 non-industry interventional studies with no phase under Phobia, Social, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 44. This study's 4 months is below that.

Counting every sponsor, half of 145 studies reached it within 28 months; a quarter within 14 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2016
First posted
Dec 22, 2016
StartActual
Jan 1, 2017
Primary completionActual
May 2017
CompletionActual
Jun 2018
Last update
Mar 7, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03001154
Lead sponsor
Stockholm University
Responsible party
Per Carlbring (Professor, Stockholm University) — Principal investigator
First posted
Dec 22, 2016
Start date
Jan 1, 2017
Primary completion
May 2017
Completion
Jun 2018
Last update
Mar 7, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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