|- candidate number||28303|
|- NTR Number||NTR6863|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||5-dec-2017|
|- Secondary IDs||2017/573; NL63206.042.17; 201700669 METC (UMCG); ABR number; UMCG|
|- Public Title||Reading the mind of the avatar: Social Cognition Training in Virtual Reality (DiSCoVR) for people with a psychotic disorder|
|- Scientific Title||Dynamic Interactive Social Cognition Training in Virtual Reality (DiSCoVR) for people with a psychotic disorder: a single-blind randomized controlled trial|
|- hypothesis||Deficits in social cognition and social functioning are commonly found in people with a psychotic disorder. While current approaches to improve social cognition are known to impact measures of social cognition, SCT may be improved by using Virtual Reality. VR is more realistic and interactive than conventional stimuli and can therefore better simulate social situations which can be used to learn and practice social cognition and functioning. We hypothesize that a VR SCT improves social cognition and social functioning, compared to an active VR control condition, and that this effect will still be present at follow-up three months after end of treatment.|
|- Healt Condition(s) or Problem(s) studied||Psychotic disorders, Schizophrenia, Social cognition, Virtual Reality, Social functioning, Theory of Mind, Emotion Recognition|
|- Inclusion criteria||- Age 18 - 65.|
- Indication of impaired social cognition by treating clinician.
- Written informed consent.
- Diagnosis of psychotic disorder, as determined by a structured clinical interview in the past three years or as determined by a diagnostic interview (MINI plus) at baseline
|- Exclusion criteria||- An estimated IQ below 70, and/or a diagnosis of intellectual disability.|
- Insufficient proficiency of the Dutch language.
- (Photosensitive) epilepsy
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2018|
|- planned closingdate||31-dec-2019|
|- Target number of participants||100|
|- Interventions||Both arms receive treatment as usual. In addition, the DiSCoVR group receives a 16-session (8 weeks, twice per week) individual intervention aimed at improving social cognition. Participants in this group practice with social situations in Virtual Reality. The intervention is provided by a therapist who gives strategy coaching and feedback. The active control group, VRelax, completes an individual, 16 session (2x per week, 8 weeks) VR relaxation training. Participants visit relaxing virtual environments (e.g., swimming with dolphins). The intervention is provided by a therapist who teaches relaxation techniques and coaches the participant in applying these in daily life.|
|- Primary outcome||Social Cognition (emotion perception, social perception and Theory of Mind)
Change in scores (from baseline to post-treatment) on Ekman 60 Faces (emotion perception), The Awareness of Social Inferece Test (TASIT; theory of mind and social perception).
|- Secondary outcome||- Social cognition scores (Ekman 60 Faces, TASIT) at follow-up, in comparison to post-treatment.|
- Social functioning, as measured using an interview (PSP) and experience sampling (custom questionnaire). Experience sampling will inquire about participantsí emotions and their (current and recent) experience of social situations (e.g., are they in company, how enjoyable is this social contact).
- Other secondary outcomes include self-esteem (SERS), social anxiety (SIAS), anxiety (BAI), depression (BDI), stress (PSS), psychotic symptoms (PANSS), information processing (TMT) and paranoia (GPTS). In the sessions, some additional behavioural and subjective experience data is collected, e.g., cyber sickness (SSQ; both groups), subjective emotions and stress (VRelax), behaviour and performance (e.g., distance from avatars, % of correct answers in exercises) in and experience of virtual environment (DiSCoVR), state anxiety (STAI; DiSCoVR), feature binding (picture task; DiSCoVR), and dissociation (CADSS; DiSCoVR).
|- Timepoints||Data will be collected at baseline (T0), post-treatment (T1) and three months after completion of treatment (T2). Some data will be collected in each session (e.g., behaviour in VR environment, emotions and stress in VRelax). Cyber sickness data will be collected in session 3 of both treatments. For DiSCoVR, state anxiety, dissociation and feature binding will be assessed between sessions 1 and 2.|
|- Trial web site||https://vrmentalhealth.nl/en/social-cognition-training/ |
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. G.H.M. (Marieke) Pijnenborg|
|- CONTACT for SCIENTIFIC QUERIES|| W.A. Veling|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|KIEM grant from NWO (Grant number 628.005.007)., GGZ Drenthe, University of Groningen - Faculty of Behavioural and Social Sciences|
|- Brief summary||People with psychotic disorders commonly have deficits in social cognition and social functioning. Current approaches to improve social cognition may not be ecologically valid, and patients cannot practice skills in dynamic social interactions, which could be solved by providing social cognition training (SCT) in Virtual Reality (VR), since VR allows for practice of skills in situations resembling real life, and at the same time is safe and controllable. To this end, DiSCoVR was developed, an individual 16-session VR-based SCT. In a multicenter Randomized Controlled Trial (n=100), we compare DiSCoVR to a VR relaxation training, VRelax, to assess the efficacy of DiSCoVR on social cognition, social functioning and other secondary measures such as psychiatric symptoms and self-esteem.|
|- Main changes (audit trail)|
|- RECORD||5-dec-2017 - 16-jun-2018|