Social PhobiaNCT03895957
VR Mind and VR Mind+ Intervention
A study testing Virtual Reality Exposure Therapy VR Mind+, Virtual Reality Exposure Therapy VR Mind and Cognitive Behavioral Therapy in people with Social Phobia, run by Tomorrow Sp. z o.o. at 2 sites in Poland.
Trial summary
The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Social Phobia
- What is being tested?
- Virtual Reality Exposure Therapy VR Mind+, Virtual Reality Exposure Therapy VR Mind and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesPoland
- Study dates
- 27 Mar 2019to 31 Dec 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- Signing informed consent
- Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated
Who cannot join
- occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
- psychosis,
- bipolar disorder,
- mental retardation
- pregnancy,
- drug addiction,
Show all 15Show fewer
- alcohol addiction,
- psychoactive substances addiction,
- participating in the experimental session while intoxicated
- (current) neurological treatment of chronic disease of central nervous system,
- epilepsy,
- paroxysmal vertigo,
- presence of suicidal thoughts, tendencies or attempts,
- participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs
- current CBT treatment for Social Anxiety Disorder
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial
The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
Read the detailed description
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
The research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator [protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist.
Participants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life).
Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.
- Conditions
- Social Phobia
- Being tested
- Virtual Reality Exposure Therapy VR Mind+, Virtual Reality Exposure Therapy VR Mind, Cognitive Behavioral Therapy
- Keywords
- virtual reality, social phobia, vret, virtual reality exposure therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure Therapy VR Mind+Behavioural
Virtual Reality Exposure Self-Therapy led by a participant
Virtual Reality Exposure Therapy VR MindBehavioural
Treatment with Virtual Reality Exposure Therapy led by a therapist
Cognitive Behavioral TherapyBehavioural
Standard treatment for social phobia led by a therapist
| Study group | Role | What they receive |
|---|---|---|
| Group 1: VR Mind+ | Experimental | Virtual Reality Exposure Therapy VR Mind+ Receives: Behavioral: Virtual Reality Exposure Therapy VR Mind+ |
| Group 2: VR Mind | Experimental | Virtual Reality Exposure Therapy VR Mind Receives: Behavioral: Virtual Reality Exposure Therapy VR Mind |
| Control group: CBT | Active comparator | Cognitive Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)
The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - "No fear" to 4 - "Severe") and avoidance (from 1 - "Never" to 4 - "Usually"). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144).
Measured: change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)
Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993)
Simulator sickness is expected adverse effect of the VR.Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores >10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as:
- mild (no intervention required),
- moderate (any intervention needed, e.g. session termination),
- severe (hospitalization required),
- life-threatening / death.
Some of the symptoms of anxiety may produce similar side effects as a simulator sickness. The results obtained in this case will be false positive. Therefore assessment of side effects for each case will be verified if the increase in SSQ score was triggered by rapid relapse of phobia symptoms.
Measured: Change from session to session with virtual reality exposure: at session 1, session 7 (4 weeks), session 8 (4 weeks), session 10 (5 weeks), session 11 (6 weeks) and session 12 (6 weeks)
Secondary outcomes (5)
Clinical Global Impression
Clinical Global Impression (CGI; Guy, 1976) - is a single item, 7 point scale used by clinicians to assess the severity of illness, where 1 is labeled as "Normal, not at all ill" and 7 is labeled as "Among the most extremely ill patients".
Measured: Pre-treatment at session 1
Clinician Global Impressions of Improvement
Global measure of change in severity of symptoms, ranging from 1 labeled as " Very much improved" to 7 labeled as "Very much worse".
Measured: Post-treatment, approximately 7 weeks after initial session
Patient Global Impression
Patient Global Impression - is a single item, 4 point scale used by patients to assess their impression of severity of their illness and quality of their functioning in everyday life, where 1 is labeled as "Normal" and 4 is labeled as "Severe".
Measured: Pre-treatment at session 1
Patient Global Impressions of Improvement
Global measure of change in severity of symptoms, where 1 is labeled as "No change" and 7 is labeled as " Very much improved ".
Measured: Post-treatment, approximately 7 weeks after initial session
Beck Depression Inventory
A 21-question multiple-choice self-report inventory for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used differ from the original:
0-13: minimal depression 14-19: mild depression 20-28: moderate depression 29-63: severe depression
Measured: Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start27 Mar 2019
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomorrow Sp. z o.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Responsible party
- Sponsor
- Investigators
- Paweł Mierzejewski, prof., Study chair, Scientific CouncilPrzemysław Bieńkowski, prof., Study director, Scientific CouncilTadeusz Parnowski, prof., Study director, Scientific CouncilSławomir Murawiec, PH.D., Study director, Scientific CouncilIzabela Stefaniak, M.D., Principal investigator, Scientific Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895957
- Sponsor's protocol ID
- TRR/POIR.01.01.01-00-0636
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial
- ClinicalTrials.gov ID
- NCT03895957
- Acronym / sponsor ID
- TRR/POIR.01.01.01-00-0636
- Conditions
- Social Phobia
- Keywords
- virtual reality, social phobia, vret, virtual reality exposure therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tomorrow Sp. z o.o.Industry (pharma, biotech, devices)
- Collaborators
- National Center for Research and Development, Poland
- Study start
- 27 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 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.
The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
Detailed description
In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.
The research consists of fourteen sessions. The first and the last session will be dedicated to participant assessment. Subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. Control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the Principal Investigator [protocol adapted from the approach of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)]. Experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. Experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. All treatment session will be led by licensed therapist.
Participants of the experimental group 2 will independently conducts the self-therapy process. The intervention will consist of 12 therapeutic sessions. At each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life).
Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: VR Mind+ | Experimental | Behavioral: Virtual Reality Exposure Therapy VR Mind+Virtual Reality Exposure Therapy VR Mind+ |
| Group 2: VR Mind | Experimental | Behavioral: Virtual Reality Exposure Therapy VR MindVirtual Reality Exposure Therapy VR Mind |
| Control group: CBT | Active comparator | Behavioral: Cognitive Behavioral TherapyCognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirmed DSM-IV-TR criteria for Social Anxiety Disorder (SAD).
- Signing informed consent
- Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated
Key exclusion criteria (15 listed)
- occurrence of SAD symptoms inconsistent with DSM-IV-TR criteria and with psychiatric interview (SCID-I; Structured Clinical Interview)
- psychosis,
- bipolar disorder,
- mental retardation
- pregnancy,
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 |
|---|---|---|
| Virtual Reality Exposure Therapy VR Mind+Virtual Reality Exposure Self-Therapy led by a participant | Behavioural | Group 1: VR Mind+ |
| Virtual Reality Exposure Therapy VR MindTreatment with Virtual Reality Exposure Therapy led by a therapist | Behavioural | Group 2: VR Mind |
| Cognitive Behavioral TherapyStandard treatment for social phobia led by a therapist | Behavioural | Control group: CBT |
Primary outcome
Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987)
Time frame: change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)
The scale is composed of 24 items, depicting various social situations. For each item, participants assess their fear (from 1 - "No fear" to 4 - "Severe") and avoidance (from 1 - "Never" to 4 - "Usually"). LSAS has 3 scores, summing the results for particular items - fear (0-72), avoidance (0-72) and total score (0-144).
Safety: Occurrence and severity of Simulator Sickness - Simulator Sickness Questionnaire (SSQ; Kennedy, Lane, Berbaum, Lilienthal, 1993)
Time frame: Change from session to session with virtual reality exposure: at session 1, session 7 (4 weeks), session 8 (4 weeks), session 10 (5 weeks), session 11 (6 weeks) and session 12 (6 weeks)
Simulator sickness is expected adverse effect of the VR.Total SSQ score equal to or higher than 10 will be used as a preliminary cut-off for simulator sickness (Balk et al., 2013). Individual scores will be corrected for baseline (pre-VR) symptom severity. Only items with a pre-VR - post-VR increase will contribute to a final SSQ score. All post-intervention SSQ scores >10 will be analyzed further for its association with study drop-outs and other intervention required. The adverse effect will be classified as: * mild (no intervention required), * moderate (any intervention needed, e.g. session termination), * severe (hospitalization required), * life-threatening / death. Some of the symptoms of anxiety may produce similar side effects as a simulator sickness. The results obtained in this case will be false positive. Therefore assessment of side effects for each case will be verified if the increase in SSQ score was triggered by rapid relapse of phobia symptoms.
5 secondary outcomes
Clinical Global Impression
Time frame: Pre-treatment at session 1
Clinician Global Impressions of Improvement
Time frame: Post-treatment, approximately 7 weeks after initial session
Patient Global Impression
Time frame: Pre-treatment at session 1
Patient Global Impressions of Improvement
Time frame: Post-treatment, approximately 7 weeks after initial session
Beck Depression Inventory
Time frame: Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)
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 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Paweł Mierzejewski, prof. study chair
Scientific Council
Przemysław Bieńkowski, prof. study director
Scientific Council
Tadeusz Parnowski, prof. study director
Scientific Council
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exposure Therapy VR Mind+, Virtual Reality Exposure Therapy VR Mind and Cognitive Behavioral Therapy in people with Social Phobia, run by Tomorrow Sp. z o.o. at 2 sites in Poland.
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 3 inclusion and 15 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 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Efficacy: Liebowitz Social Anxiety Scale - Liebowitz Social Anxiety Scale (LSAS; Liebowitz, 1987) (time frame: change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)). The study lists 2 primary outcomes in all. 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 11 Feb 2020.