Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2019-03-27
2019-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1: VR Mind+
Virtual Reality Exposure Therapy VR Mind+
Virtual Reality Exposure Therapy VR Mind+
Virtual Reality Exposure Self-Therapy led by a participant
Group 2: VR Mind
Virtual Reality Exposure Therapy VR Mind
Virtual Reality Exposure Therapy VR Mind
Treatment with Virtual Reality Exposure Therapy led by a therapist
Control group: CBT
Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Standard treatment for social phobia led by a therapist
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Signing informed consent
* Unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated
Exclusion Criteria
* 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
18 Years
50 Years
ALL
No
Sponsors
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National Center for Research and Development, Poland
OTHER
Tomorrow Sp. z o.o.
INDUSTRY
Responsible Party
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Principal Investigators
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Paweł Mierzejewski, prof.
Role: STUDY_CHAIR
Scientific Council
Przemysław Bieńkowski, prof.
Role: STUDY_DIRECTOR
Scientific Council
Tadeusz Parnowski, prof.
Role: STUDY_DIRECTOR
Scientific Council
Sławomir Murawiec, PH.D.
Role: STUDY_DIRECTOR
Scientific Council
Izabela Stefaniak, M.D.
Role: PRINCIPAL_INVESTIGATOR
Scientific Council
Locations
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Tomorrow Sp. z o. o.
Warsaw, , Poland
Gabinet Psychoterapii
Warsaw, , Poland
Countries
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Other Identifiers
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TRR/POIR.01.01.01-00-0636
Identifier Type: -
Identifier Source: org_study_id
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