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van CCT (UK)

van CCT (UK)

A virtual reality game for OCD

- candidate number24681
- NTR NumberNTR5935
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-jul-2016
- Secondary IDsNL46697.018.13 // 2013_317  CCMO // METC AMC
- Public TitleA virtual reality game for OCD
- Scientific TitleA virtual reality game for patients with Obsessive-Compulsive Disorder
- ACRONYMA virtual reality game for OCD
- hypothesisWe expect the VR-game to provoke emotional responses and compulsive behavior in OCD patients. Additionally, we expect autonomic effects to correspond with emotional responses in OCD patients.
We hypothesize that the subjective and objective output scores, as well as the autonomic effects, will be significantly higher in OCD patients as compared to healthy controls.
- Healt Condition(s) or Problem(s) studiedObsessive-compulsive disorder (OCD)
- Inclusion criteria- Diagnosis of primary OCD by DSM-IV criteria, confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual for Mental Disorders (SCID, DSM-IV)
- Age between 18-65
- Written informed consent of the subject
- Exclusion criteria- Severe neurological disorders (including seizures) and cardiovascular disorders, as derived from medical history
- Mental retardation
- Severe comorbid axis I disorders including schizophrenia like disorders and bipolar disorder
- Alcohol or substance abuse (including benzodiazepines) during the last 6 months
- Use of alcohol or benzodiazepines in the 24 hours prior to investigation or recreational drugs in the 72 hours prior to investigation
- Abnormal hearing and uncorrected vision
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 24-feb-2014
- planned closingdate1-mrt-2017
- Target number of participants54
- InterventionsVirtual reality game
- Primary outcome- Self-reported experienced emotional responses during the game, subdivided in anxiety, unrest, insecurity and control need.
- Number of compulsions performed in the VR-game
- Secondary outcome- Autonomic variables recorded during performance of the VR-game such as heart-rate variability and skin conductance
- Timepoints- Participation will take up to two hours. OCD patients will be called the day after to evaluate side-effects.
- Trial web site
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIES Martine van Bennekom
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryRationale:
Obsessive-compulsive disorder (OCD) is a chronic psychiatric disorder characterized by obsessions (e.g. contamination fear) and repetitive compulsions (e.g. excessive washing). To date, the severity of OCD symptoms is assessed with retrospective and largely subjective clinician-rated questionnaires. Interestingly, virtual reality (VR) can be used to actively provoke and assess OCD specific symptoms in a controlled and standardized environment. We will investigate a VR-game designed to provoke OCD symptoms and assesses OCD symptom severity in different OCD-specific situations. If OCD symptom severity can be assessed in VR, subjective and retrospective limitations will resolve, leading to more accurate, efficient and objective OCD diagnostics.

The main goal of this study is to validate the VR game. First, we will investigate whether the VR-game is able to provoke OCD-specific symptoms in OCD patients. The VR-game generates subjective and objective output scores. Subjective output scores are the self-reported emotional responses, subdivided in anxiety, unrest, insecurity and control need. Objective output scores express compulsive behaviour as performed in the VR-game. To objectify the self-reported emotional responses, autonomic effects will be recorded. We hypothesize that the subjective and objective output scores as well as the autonomic effects will be significantly higher in OCD patients as compared to healthy controls.

Study design:
Two groups of participants, consisting of OCD patients and healthy controls, will participate in this study. These groups will participate in a cross sectional study and will play the VR-game while autonomic effects are recorded.
- Main changes (audit trail)
- RECORD24-jul-2016 - 20-aug-2016

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