Public SpeakingVRETANCT03885414
Virtual Reality Exposure Therapy for Public Speaking Anxiety
A study testing In-session Virtual Reality exposure therapy and Internet-administered transition program in people with Public Speaking and Social Anxiety, run by Stockholm University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Public Speaking, Social Anxiety, Social Anxiety Disorder, Performance Only
- What is being tested?
- In-session Virtual Reality exposure therapy and Internet-administered transition program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSweden
- Study dates
- 14 Jan 2019to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial
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.
- Being tested
- In-session Virtual Reality exposure therapy, Internet-administered transition program
- Medical subject headings
- Speech, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-session Virtual Reality exposure therapyBehavioural
Also called Virtual reality therapy, Exposure therapy, Cognitive behavioral therapy
A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.
Internet-administered transition programBehavioural
Also called Internet intervention
Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.
| Study group | Role | What they receive |
|---|---|---|
| OST-VRET + in-vivo transition program | Experimental | 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. Receives: Behavioral: In-session Virtual Reality exposure therapy; Behavioral: Internet-administered transition program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline: Public Speaking Anxiety Scale
Canonical total score will be used. Measure is self-rated, online. Swedish translation of the original PSAS (Bartholomay \& Houlihan, 2016)
Measured: 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
Secondary outcomes (5)
Change from baseline: Brunnsviken Brief Quality of life scale
Canonical total score will be used. Measure is self-rated, online.
Measured: Change from baseline: (1) 7 days post-OST, (4) 35 days post-OST, (5) 125 days post-PST
Change from baseline: Liebowitz Social Anxiety Scale Self-Report
Canonical total score will be used. Measure is self-rated, online.
Measured: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Change from baseline: Brief Fear of Negative Evaluation Scale
Canonical total score will be used. Measure is self-rated, online.
Measured: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Change from baseline: Patient Health Questionnaire 9-item
Canonical total score will be used. Measure is self-rated, online.
Measured: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Change from baseline: Generalized Anxiety Disorder 7-item
Canonical total score will be used. Measure is self-rated, online.
Measured: Change from baseline: (1) 7 days post-OST, (2) 35 days post-OST, (3) 125 days post-PST
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start14 Jan 2019
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Public SpeakingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multiple baseline
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Collaborators
- PBM, Mimerse
- Responsible party
- Principal investigator, Per Carlbring, Stockholm University
- Investigators
- Per Carlbring, PhD, Principal investigator, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885414
- Sponsor's protocol ID
- VRETA
- Acronym
- VRETA
- Status last verified
- Jan 2020
- First submitted
- 11 Mar 2019
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymous outcome measure IPD will be made available upon request from academic researchers.
Publications
Lindner P, Miloff A, Fagernas 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.
PubMed 30054173
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy for Public Speaking Anxiety: A Multiple-baseline Effectiveness Trial
- ClinicalTrials.gov ID
- NCT03885414
- Acronym / sponsor ID
- VRETA / VRETA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Collaborators
- PBM, Mimerse
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multiple baseline
| Arm | Type | Receives |
|---|---|---|
| OST-VRET + in-vivo transition program | Experimental | Behavioral: In-session Virtual Reality exposure therapy, Behavioral: Internet-administered transition programOne-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-session Virtual Reality exposure therapyAlso: Virtual reality therapy, Exposure therapy, Cognitive behavioral therapyA series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback. | Behavioural | OST-VRET + in-vivo transition program |
| Internet-administered transition programAlso: Internet interventionFour-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings. | Behavioural | OST-VRET + in-vivo transition program |
Primary outcome
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)
5 secondary outcomes
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Background: PubMed 30054173Lindner P, Miloff A, Fagernas 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.
- Study website (Swedish)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Anonymous outcome measure IPD will be made available upon request from academic researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Carlbring, PhD principal investigator
Stockholm University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-session Virtual Reality exposure therapy and Internet-administered transition program in people with Public Speaking and Social Anxiety, run by Stockholm University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885414, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.