Social PhobiaVRETORIKNCT03001154
Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
A study testing Face-to-face Virtual Reality Exposure Therapy, Internet-administered Virtual Reality Exposure Therapy and Waiting-list in people with Social Phobia and Anxiety, run by Stockholm University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Phobia, Anxiety, Behavior Therapy
- What is being tested?
- Face-to-face Virtual Reality Exposure Therapy, Internet-administered Virtual Reality Exposure Therapy and Waiting-list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2017to Jun 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
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.
- Conditions
- Social Phobia, Anxiety, Behavior Therapy
- Being tested
- Face-to-face Virtual Reality Exposure Therapy, Internet-administered Virtual Reality Exposure Therapy, Waiting-list
- Medical subject headings
- Phobia, Social, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face-to-face Virtual Reality Exposure TherapyBehavioural
In session, systematic, hierarchical exposure to feared stimuli with therapist.
Internet-administered Virtual Reality Exposure TherapyBehavioural
Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program
Waiting-listOther
Weekly assessments of public speaking
| Study group | Role | What they receive |
|---|---|---|
| One-session VRET face-to-face | Experimental | One-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program. Receives: Behavioral: Face-to-face Virtual Reality Exposure Therapy |
| Waiting-list, then Internet-administered VRET | Experimental | 4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program. Receives: Behavioral: Internet-administered Virtual Reality Exposure Therapy; Other: Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Public Speaking Anxiety Scale
Self-rating of public speaking anxiety
Measured: Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
Secondary outcomes (5)
Liebowitz Social Anxiety Scale Self-Report
Self-rating of general social anxiety
Measured: Change from baseline: Week 0, 5 and 21
Brief Fear of Negative Evaluation Scale
Self-rating of fear of negative evaluation
Measured: Change from baseline: Week 0, 5 and 21
Patient Health Questionnaire 9-item
Self-rating of depressive symptoms
Measured: Change from baseline: Week 0, 5 and 21
Generalized Anxiety Disorder 7-item
Self-rating of general anxiety symptoms
Measured: Change from baseline: Week 0, 5 and 21
Brunnsviken Brief Quality of life scale
Self-rating of quality of life
Measured: Change from baseline: Week 0, 5 and 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study start1 Jan 2017
- Primary completionMay 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social PhobiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stockholm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Carlbring, Stockholm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03001154
- Sponsor's protocol ID
- VRetorik
- Acronym
- VRETORIK
- Status last verified
- Mar 2019
- First submitted
- 20 Dec 2016
- Last updated
- 7 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Exposure Therapy for Speech Anxiety Using Commercial Hardware and Software
- ClinicalTrials.gov ID
- NCT03001154
- Acronym / sponsor ID
- VRETORIK / VRetorik
- Conditions
- Social Phobia, Anxiety, Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Stockholm UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 22 Dec 2016 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-session VRET face-to-face | Experimental | Behavioral: Face-to-face Virtual Reality Exposure TherapyOne-session Virtual Reality Exposure Therapy led by therapist (face-to-face), followed by a 4-week therapist-guided Internet-administered progressive maintenance program. |
| Waiting-list, then Internet-administered VRET | Experimental | Behavioral: Internet-administered Virtual Reality Exposure Therapy, Other: Waiting-list4-week waiting list, followed by therapist-guided, Internet-administered VRET with a 4-week progressive maintenance program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Face-to-face Virtual Reality Exposure TherapyIn session, systematic, hierarchical exposure to feared stimuli with therapist. | Behavioural | One-session VRET face-to-face |
| Internet-administered Virtual Reality Exposure TherapyTherapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program | Behavioural | Waiting-list, then Internet-administered VRET |
| Waiting-listWeekly assessments of public speaking | Other | Waiting-list, then Internet-administered VRET |
Primary outcome
Public Speaking Anxiety Scale
Time frame: Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21
Self-rating of public speaking anxiety
5 secondary outcomes
Liebowitz Social Anxiety Scale Self-Report
Time frame: Change from baseline: Week 0, 5 and 21
Brief Fear of Negative Evaluation Scale
Time frame: Change from baseline: Week 0, 5 and 21
Patient Health Questionnaire 9-item
Time frame: Change from baseline: Week 0, 5 and 21
Generalized Anxiety Disorder 7-item
Time frame: Change from baseline: Week 0, 5 and 21
Brunnsviken Brief Quality of life scale
Time frame: Change from baseline: Week 0, 5 and 21
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 7 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face-to-face Virtual Reality Exposure Therapy, Internet-administered Virtual Reality Exposure Therapy and Waiting-list in people with Social Phobia and 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 7 Mar 2019. 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?
Public Speaking Anxiety Scale (time frame: Change from baseline: Week 0, 1, 2, 3, 4, 5 and 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2019.