VR Mind and VR Mind+ Intervention

Social Phobia Clinical Trial

Official title:

VR Mind™ and VR Mind +™ Intervention - Randomized, Open Label, Single Masking, Parallel Group Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895957
• Other study ID #: TRR/POIR.01.01.01-00-0636
• Status: Completed
• Phase: N/A
• Start date: March 27, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: Tomorrow Sp. z o.o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind + interventions.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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,

• 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

Related Conditions & MeSH terms

• Phobia, Social
• Social Phobia

Intervention

Behavioral:
• Virtual Reality Exposure Therapy VR Mind+
Virtual Reality Exposure Self-Therapy led by a participant
• Virtual Reality Exposure Therapy VR Mind
Treatment with Virtual Reality Exposure Therapy led by a therapist
• Cognitive Behavioral Therapy
Standard treatment for social phobia led by a therapist

Locations

Country	Name	City	State
Poland	Gabinet Psychoterapii	Warsaw
Poland	Tomorrow Sp. z o. o.	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Tomorrow Sp. z o.o.	The National Centre for Research and Development

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subjective Units of Distress	Subjective Units of Distress (SUD) SUD is a subjective measure of perceived fear in certain situation. The scale range is from 0 ("Totally relaxed) to 100 ("Highest distress/fear/anxiety/discomfort that you have ever felt").	Change from session to session with virtual reality exposure during the course of six weeks
Primary	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).	change from baseline: Pre-treatment at session 1, to session 9 (5 weeks) and to post-treatment at session 14 (7 weeks)
Primary	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.	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	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".	Pre-treatment at session 1
Secondary	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".	Post-treatment, approximately 7 weeks after initial session
Secondary	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".	Pre-treatment at session 1
Secondary	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 ".	Post-treatment, approximately 7 weeks after initial session
Secondary	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	Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)