VR Mind and VR Mind+ Intervention

NCT03895957 | Completed DMC

• 1 other identifier: TRR/POIR.01.01.01-00-0636
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Social Phobia

Keywords

virtual reality; social phobia; vret; virtual reality exposure therapy

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

• Clinical Global Impression

  Pre-treatment at session 1

• Clinician Global Impressions of Improvement

  Post-treatment, approximately 7 weeks after initial session

• Patient Global Impression

  Pre-treatment at session 1

• Patient Global Impressions of Improvement

  Post-treatment, approximately 7 weeks after initial session

• Beck Depression Inventory

  Pre-treatment at session 1 to post-treatment at session 14 (7 weeks)

Other Outcomes (1)

• Subjective Units of Distress

  Change from session to session with virtual reality exposure during the course of six weeks

Study Arms (3)

Group 1: VR Mind+

EXPERIMENTAL

Virtual Reality Exposure Therapy VR Mind+

Behavioral: Virtual Reality Exposure Therapy VR Mind+

Group 2: VR Mind

EXPERIMENTAL

Virtual Reality Exposure Therapy VR Mind

Behavioral: Virtual Reality Exposure Therapy VR Mind

Control group: CBT

ACTIVE COMPARATOR

Cognitive Behavioral Therapy

Behavioral: Cognitive Behavioral Therapy

Interventions

Virtual Reality Exposure Therapy VR Mind BEHAVIORAL

Treatment with Virtual Reality Exposure Therapy led by a therapist

Group 2: VR Mind

Cognitive Behavioral Therapy BEHAVIORAL

Standard treatment for social phobia led by a therapist

Control group: CBT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tomorrow Sp. z o.o.: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (2)

Tomorrow Sp. z o. o.

Warsaw, 03-913, Poland

Location

Gabinet Psychoterapii

Warsaw, Poland

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Paweł Mierzejewski, prof.

  Scientific Council

  STUDY CHAIR

• Przemysław Bieńkowski, prof.

  Scientific Council

  STUDY DIRECTOR

• Tadeusz Parnowski, prof.

  Scientific Council

  STUDY DIRECTOR

• Sławomir Murawiec, PH.D.

  Scientific Council

  STUDY DIRECTOR

• Izabela Stefaniak, M.D.

  Scientific Council

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 29, 2019
• Study Start: March 27, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 11, 2020

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)