Mental Health IssueNCT04396392
VR-based Exposure Training for Adolescents With Fear of Public Speaking
A study testing VR-based training in people with Mental Health Issue and Adolescent Development, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Public speaking anxiety (PSA) is a common anxiety with onset in adolescence and early adulthood. With the advent of consumer Virtual Reality (VR) technology, VR-delivered exposure therapy has previously been shown to be efficacious with adults. Read more about this study
- Who is it for?
- Ages 13 to 16 years
- Conditions the study is for
- Mental Health Issue, Adolescent Development, Technology
- What is being tested?
- VR-based training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2020to 3 Mar 2022
- 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 13 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 13-16, Symptoms of PSA, as defined by Public Speaking Anxiety Scale (PSAS) which leads to distress and / or negative consequences at school. Based on data from the feasibility study (Kahlon et.al 2019) the cut-off will be PSAS < 55.
- -
Who cannot join
- Current ongoing treatment for mental health problems (psychoactive medication/psychotherapy) impaired eyesight and lack of stereoscopic vision which cause difficulties in the VR experience and balance problems
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VR-based Training for Adolescents With Fear of Public Speaking, a Randomized Controlled Trial
Public speaking anxiety (PSA) is a common anxiety with onset in adolescence and early adulthood. With the advent of consumer Virtual Reality (VR) technology, VR-delivered exposure therapy has previously been shown to be efficacious with adults. Virtual reality has existed for several decades, but it is only in the recent years it has become readily available. The new generation of off-the-shelf, consumer VR hardware, can revolutionize the design, availability and dissemination of VR therapist tools for exposure therapies. Importantly, there has been relatively little research on VR delivered exposure of anxiety in social situations compared to other anxiety disorders, presumably due to the complexity of the virtual stimuli required. There has been no study on VR delivered exposure specifically for adolescents until recently. A feasibility and pilot trial laying the foundation of the current study showed great potential in using VR for adolescents with PSA. The current study aims to investigate the efficacy of a self-guided VR intervention compared to a self-guided internet-delivered text-based intervention using a two-phased randomized design. Adolescents aged 13-16 will be invited to participate in the study
Read the detailed description
The study is a two-phased intervention study .
Participants with PSA will be randomized into three self-guided intervention groups and one delayed waiting list group as follows:
Group 1: receiving VR intervention (3 weeks)
Group 2: receiving VR intervention (3 weeks) + text-based exposure program (T-B-Exp) (3 weeks)
Group 3: receiving text-based psychoeducation and exposure program (T-B PE + T-B Exp) (6 weeks)
Group 4: Waitlist (3 weeks) + receiving text-based psychoeducation (T-B PE) (3 weeks)
Interventions:
- The VR intervention is a self-guided and home-based VR intervention that lasts for three weeks and focuses on exposure training. The VR group will receive the VR headset personally, in addition to instructional text about how the VR intervention works, how to use the VR application and how often to train. They will be instructed at least 5 tasks weekly during the intervention program.
- The text-based Psychoeducation intervention is a three weeks program with three modules. One module will be assigned weekly, together with the weekly assessments, which will be same for all participants. The participants will receive a notification on text message when a module has been assigned to them. Module 1 will include information about the intervention program, psychoeducation about public speaking anxiety, cognitive therapy and case formulation. Module 2 will focus on catastrophic beliefs; how to recognize, how they develop, how they contribute to maintaining the anxiety and how they can be tested. Module 3 focuses on safety strategies; what they are, how they contribute in maintaining anxiety, and how to identify them.
- The Text-based exposure intervention is a three weeks program with 3 modules. One module will be assigned weekly, together with weekly assessments. The modules will focus on how to practice exposure in real life (in vivo) and relapse prevention.
- The waitlist group will be in waitlist mode for three weeks while the intervention groups are in phase 1. They will still receive weekly assessments during phase 1.
- Conditions
- Mental Health Issue, Adolescent Development, Technology
- Being tested
- VR-based training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-based trainingBehavioural
Also called text-based training
All interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home.
All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to.
| Study group | Role | What they receive |
|---|---|---|
| VR-based training | Experimental | receiving only VR intervention Receives: Behavioral: VR-based training |
| text-based training | Active comparator | receiving only text-based intervention Receives: Behavioral: VR-based training |
| VR- and text-based training | Experimental | receiving both VR intervention and text-based intervention Receives: Behavioral: VR-based training |
| waiting list | No intervention | waiting list in phase 1 and text-based training after 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Public Speaking Anxiety Scale
A new, modern, reliable and valid self-rating scale (Bartholomay \& Houlihan, 2016). The PSAS features 17 items (5 of which are reverse-coded) covering cognitive, behavioral and physiological aspects of PSA. Since the PSAS features a full Likert item response format, it should be more sensitive to change than older rating scales such as the Personal Report of Confidence as a Speaker (Phillips, Jones, Rieger, \& Snell, 1997). Normative score data is however as of yet missing. This scale is translated into Norwegian according to scientific standards (back-translation.). Although intended for adults, the wording did not present any problem for adolescents in our feasibility study. lower score means lower symptom-leves
Measured: 18 months
Secondary outcomes (3)
Change in Social Interaction Anxiety Scale
Fear of social interaction distinguishes performance-only from generalized SAD. As such, degree of social interaction anxiety is a likely moderator of treatment response in the current study. A combination of Social Interaction Anxiety Scale (SIAS) 6 and the Social Phobia Scale (SPS) 6 has proven to be a validated measure to measure the more generalized form of social anxiety and gives us a short screening tool which is easy to assess (Peters, Sunderland, Andrews, Rapee, \& Mattick, 2012). This scale is translated into Norwegian according to scientific standards (back-translation.).
By collecting data on the 12-item short version of SIAS at both pre and post and FU the aim is to investigate whether VRET for PSA has a treatment effect on generalized social anxiety lower score means lower symptom-levels. scale from 0-80.
Measured: 18 months
Change in Catastrophic belief expectancy
Expectancy ratings of aversive consequences are a valid, simple way of assessing the strength of conditioning (Boddez et al., 2013) and a hypothesis is that a decrease in catastrophic beliefs expectancies will also cause a reduction in PSA symptoms . One-item scale for CBE will be assessed weekly together with the primary outcome measure PSAS. They will be asked to answer, "How sure are you that the most aversive consequence when giving a speech is likely to happen?" on as scale from 0-100.
Alternative: "How sure are that you will sweat, shake, and/or rødme visibly? How sure are you that you will speak in a weird way? (snakke rart). How sure are you that you will have difficulties speaking? How sure are you that others will think negatively of you?
Measured: 18 months
Change in Social Phobia Scale
Fear of social performance, By collecting data on the 12-item short version of SPS at both pre and post and FU the aim is to investigate whether VRET for PSA has a treatment effect on performance social anxiety.
lower score means lower symptom-levels. scale from 0-80.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2020
- Study start1 Mar 2020
- Primary completion3 Mar 2022 (estimated)
- Study completion3 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- The study is a two-phased intervention study Participants with PSA will be randomized into three self-guided intervention groups and one delayed waiting list group as follows: Group 1: receiving VR intervention (3 weeks) Group 2: receiving VR intervention (3 weeks) + text-based exposure program (T-B-Exp) (3 weeks) Group 3: receiving text-based psychoeducation and exposure program (T-B PE + T-B Exp) (6 weeks) Group 4: Waitlist (3 weeks) + receiving text-based psychoeducation (T-B PE) (3 weeks)
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396392
- Sponsor's protocol ID
- 60628
- Status last verified
- May 2021
- First submitted
- 11 Feb 2020
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided how this should be done yet
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR-based Training for Adolescents With Fear of Public Speaking, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04396392
- Acronym / sponsor ID
- 60628
- Conditions
- Mental Health Issue, Adolescent Development, Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 3 Mar 2022 (estimated)
- Study completion
- 3 Mar 2022 (estimated)
- First posted
- 20 May 2020 (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.
Public speaking anxiety (PSA) is a common anxiety with onset in adolescence and early adulthood. With the advent of consumer Virtual Reality (VR) technology, VR-delivered exposure therapy has previously been shown to be efficacious with adults. Virtual reality has existed for several decades, but it is only in the recent years it has become readily available. The new generation of off-the-shelf, consumer VR hardware, can revolutionize the design, availability and dissemination of VR therapist tools for exposure therapies. Importantly, there has been relatively little research on VR delivered exposure of anxiety in social situations compared to other anxiety disorders, presumably due to the complexity of the virtual stimuli required. There has been no study on VR delivered exposure specifically for adolescents until recently. A feasibility and pilot trial laying the foundation of the current study showed great potential in using VR for adolescents with PSA. The current study aims to investigate the efficacy of a self-guided VR intervention compared to a self-guided internet-delivered text-based intervention using a two-phased randomized design. Adolescents aged 13-16 will be invited to participate in the study
Detailed description
The study is a two-phased intervention study .
Participants with PSA will be randomized into three self-guided intervention groups and one delayed waiting list group as follows:
Group 1: receiving VR intervention (3 weeks)
Group 2: receiving VR intervention (3 weeks) + text-based exposure program (T-B-Exp) (3 weeks)
Group 3: receiving text-based psychoeducation and exposure program (T-B PE + T-B Exp) (6 weeks)
Group 4: Waitlist (3 weeks) + receiving text-based psychoeducation (T-B PE) (3 weeks)
Interventions:
- The VR intervention is a self-guided and home-based VR intervention that lasts for three weeks and focuses on exposure training. The VR group will receive the VR headset personally, in addition to instructional text about how the VR intervention works, how to use the VR application and how often to train. They will be instructed at least 5 tasks weekly during the intervention program.
- The text-based Psychoeducation intervention is a three weeks program with three modules. One module will be assigned weekly, together with the weekly assessments, which will be same for all participants. The participants will receive a notification on text message when a module has been assigned to them. Module 1 will include information about the intervention program, psychoeducation about public speaking anxiety, cognitive therapy and case formulation. Module 2 will focus on catastrophic beliefs; how to recognize, how they develop, how they contribute to maintaining the anxiety and how they can be tested. Module 3 focuses on safety strategies; what they are, how they contribute in maintaining anxiety, and how to identify them.
- The Text-based exposure intervention is a three weeks program with 3 modules. One module will be assigned weekly, together with weekly assessments. The modules will focus on how to practice exposure in real life (in vivo) and relapse prevention.
- The waitlist group will be in waitlist mode for three weeks while the intervention groups are in phase 1. They will still receive weekly assessments during phase 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study is a two-phased intervention study Participants with PSA will be randomized into three self-guided intervention groups and one delayed waiting list group as follows: Group 1: receiving VR intervention (3 weeks) Group 2: receiving VR intervention (3 weeks) + text-based exposure program (T-B-Exp) (3 weeks) Group 3: receiving text-based psychoeducation and exposure program (T-B PE + T-B Exp) (6 weeks) Group 4: Waitlist (3 weeks) + receiving text-based psychoeducation (T-B PE) (3 weeks)
| Arm | Type | Receives |
|---|---|---|
| VR-based training | Experimental | Behavioral: VR-based trainingreceiving only VR intervention |
| text-based training | Active comparator | Behavioral: VR-based trainingreceiving only text-based intervention |
| VR- and text-based training | Experimental | Behavioral: VR-based trainingreceiving both VR intervention and text-based intervention |
| waiting list | No intervention | –waiting list in phase 1 and text-based training after 3 weeks |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Aged 13-16, Symptoms of PSA, as defined by Public Speaking Anxiety Scale (PSAS) which leads to distress and / or negative consequences at school. Based on data from the feasibility study (Kahlon et.al 2019) the cut-off will be PSAS < 55.
- -
Key exclusion criteria (2 listed)
- Current ongoing treatment for mental health problems (psychoactive medication/psychotherapy) impaired eyesight and lack of stereoscopic vision which cause difficulties in the VR experience and balance problems
- -
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 |
|---|---|---|
| VR-based trainingAlso: text-based trainingAll interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home. All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to. | Behavioural | VR- and text-based training, VR-based training, text-based training |
Primary outcome
Change in Public Speaking Anxiety Scale
Time frame: 18 months
A new, modern, reliable and valid self-rating scale (Bartholomay \& Houlihan, 2016). The PSAS features 17 items (5 of which are reverse-coded) covering cognitive, behavioral and physiological aspects of PSA. Since the PSAS features a full Likert item response format, it should be more sensitive to change than older rating scales such as the Personal Report of Confidence as a Speaker (Phillips, Jones, Rieger, \& Snell, 1997). Normative score data is however as of yet missing. This scale is translated into Norwegian according to scientific standards (back-translation.). Although intended for adults, the wording did not present any problem for adolescents in our feasibility study. lower score means lower symptom-leves
3 secondary outcomes
Change in Social Interaction Anxiety Scale
Time frame: 18 months
Change in Catastrophic belief expectancy
Time frame: 18 months
Change in Social Phobia Scale
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: Undecided. Not decided how this should be done yet
Related trials for Mental Health Issue
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
Recruiting
VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia
Lewy Bodies Disease, Depression Disorder
Active, not recruiting
Tailoring CPP for the Foster Care Setting
Behavior Problem
Active, not recruiting
Supporting Health in Veterans With Heart Failure
Heart Failure
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 VR-based training in people with Mental Health Issue and Adolescent Development, run by Haukeland University Hospital at 1 site in Norway.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 6 May 2021. 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 Norway. 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?
Results are not available in the source record.
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 in Public Speaking Anxiety Scale (time frame: 18 months). 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 6 May 2021.