Dynamic Interactive Social Cognition Training in Virtual Reality (DiSCoVR) for people with a psychotic disorder.|
|- 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|- ISRCTN||ISRCTN no longer applicable|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; 628.005.007 METC file number; ABR number; NWO Grant number|
|- Public Title||Dynamic Interactive 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.|
|- hypothesis||People with a psychotic disorder experience problems in social cognition. We hypothesise that these deficits can be ameliorated by practicing with social situations and social cognition in Virtual Reality (VR), because VR is highly interactive and realistic, but at the same time controllable and safe. It is therefore a practical and approachable way for people to practice daily social interactions. We have developed an intervention to improve social cognition in VR, called DiSCoVR. In this trial, we compare DiSCoVR to an active control group, Virtual Reality relaxation (VRelax). We hypothesise that DiSCoVR will improve social cognition and social functioning. We also hypothesise that VRelax will reduce anxiety and stress. |
|- Healt Condition(s) or Problem(s) studied||Psychotic disorders, Schizophrenia, Social cognition, Virtual Reality|
|- Inclusion criteria||1. Diagnosis of a psychotic disorder, determined by a structured interview (SCAN/ SCID/ M.I.N.I./ M.I.N.I. plus interview) in the previous three years or determined by the M.I.N.I. plus interview during baseline measurements. |
2. Age 18 - 65.
3. Indication of impaired social cognition by treating clinician.
4. Written informed consent.
|- Exclusion criteria||1. An estimated IQ below 70, and/or a diagnosis of intellectual disability.|
2. Insufficient proficiency of the Dutch language.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2018|
|- planned closingdate||31-dec-2019|
|- Target number of participants||100|
|- Interventions||The SCT consists of sixteen sessions, which last 45-60 minutes each. During these sessions, participants in the VR SCT group navigate virtual environments developed to train social cognitive skills. The VR SCT is provided by a therapist, that is, a psychologist or other mental healthcare professional who has been trained to apply the treatment protocol. This therapist has the following tasks:
1. Operating the VR system and assisting the participant in the use of the VR technology (as explained above).
2. To tailor the training (e.g., difficulty level) to the abilities and needs of the participant.
3. To formulate strategies with the participant which they can use in the exercises, and to evaluate the performance of the participant during the exercises and tweak their strategies accordingly.
4. To observe the behavior of the participant in the virtual environment and provide feedback on the utility and functionality thereof (e.g., gaze, interactive behaviors). For example, if a participant avoids eye contact with avatars, a therapist may comment on this and encourage participants to explore facial features to improve affect recognition.
5. To control the dialog function in the latter part of the training (explained below).
6. Reporting (e.g., session content, duration, protocol deviations).
DiSCoVR consists of three modules, targeting different domains of social cognition: emotion perception; social perception & ToM; and social interaction training. At the end of each session, participants are given an (optional) homework assignment, which are intended to promote the use of the intervention’s techniques in daily life.
Module 1: Emotion Perception (sessions 1-5)
Participants walk around the virtual environment and encounter virtual characters (avatars) who show dynamic facial emotions. Participants will be trained to recognize these emotions by using strategy coaching (i.e., helping the participant to choose the most appropriate strategy to complete a task), practice, and attentional direction to salient features (i.e., the face and mouth, which provide important affective cues). Participants are encouraged to explore the avatars’ facial features, and identify the emotion that they portray out of six basic emotions (happiness, surprise, fear, disgust, anger and sadness). Participants choose the correct emotion by selecting it with their joystick in a multiple-choice menu that is shown in their field of vision. Homework exercises during this module include recognizing emotions in the home environment, so that participants learn to employ FAR strategies in their daily lives.
Module 2: Social Perception & ToM (sessions 6-9)
In this part of the intervention, participants witness conversations between avatars. The goal of this module is to place emotions into a narrative. By introducing context, participants are taught to consider situational information in order to judge the thoughts, emotions and behaviors of others. The social scenarios generally include multiple versions and/or endings, in which many factors are equal but one crucial factor differs: e.g., an avatar is having a good day or a bad day, which is reflected in their reactions. At different points during the scenario, the participant is prompted to assess the emotions and/or thoughts of the avatar. If the participant gives a wrong answer, the avatars will more explicitly state their thoughts, intentions and/or emotions, after which participants are prompted to try again. Participants analyze social situations by assessing (the relations between) thoughts, emotions and behavior. Using this ‘GGG-model’ (gedachten, gevoelens, gedrag), participants learn to understand why others act in a certain way and how mental states are influenced by situations and other people. At this stage in the intervention, homework exercises consist of assessing thoughts, behavior and emotions of participants themselves and others in their daily environments.
Module 3: Social Interaction Training (sessions 10-16)
In the final module, participants learn to apply the techniques and strategies they acquired in the first two modules. They practice in one-on-one role play interactions in the virtual environment. The therapist interacts with the participant through an avatar, using a transformed voice. Since the participant is wearing the VR headset and noise cancelling headphones, it appears to them that they are interacting with a virtual person. Role play situations are tailored as much as possible to the participant’s goals; however, occasionally, standard scenarios are used, for example, in case participants do not contribute situations they’d like to practice with. To help participants determine how to react in a social situation, participants use a series of steps: 1) determine your own thoughts, emotions and behavior (GGG); 2) determine the other person’s thoughts, emotions and behavior (GGG); 3) list the possible ways you could react; 4) evaluate how desirable each option is (and, if possible, practice it by role playing); and 5) choose the reaction with the most desirable outcome. In the final part of the intervention, participants use this series of steps in difficult social situations they encounter in their daily lives.
The control condition also consists of 16 weekly one-on-one sessions of 60 minutes with a therapist. It is matched to the DiSCoVR condition for therapist contact and use of VR. VRelax is relaxation therapy using 360 degrees videos in VR (www.vrmentalhealth.org). The videos are played using a Samsung Gear VR head-mounted display, powered by a Samsung Galaxy smartphone. Several environments are available, including swimming with dolphins, a beach and a forest. Relaxation exercises such as progressive muscle relaxation and guided meditation are embedded in the videos. Participants can look around in 360 degrees by moving their head. The Gear VR registers head movement and adjusts the image accordingly. Participants can navigate between environments and activate relaxation exercises by looking at hotspots within the videos.
|- Primary outcome||The primary outcome variable of this study is social cognition:|
- Emotion perception (Ekman 60 Faces)
- Social perception & Theory of mind (The Awareness of Social Inference Task)
|- Secondary outcome||Our main secondary outcome of interest is social functioning, using an both interview and measurements in the daily life of the participant using Experience Sampling (ESM). For this purpose, participants are prompted to answer questions several times a day about their (social) activities and their assessment and experience of these activities.
We also study the following secondary outcomes:
- Information processing (Trailmaking Test)
- Social anxiety (Social Anxiety and Interaction Scale)
- Self-esteem (Self-Esteem Rating Scale)
- Depression (Beck Depression Inventory)
- Psychotic symptoms (Positive and Negative Syndrome Scale)
- Stress (Perceived Stress Scale)
- Anxiety (Beck Anxiety Inventory)
|- Timepoints||Participants are assessed at three time points:|
- Baseline (T0)
- Post-treatment (T1)
- Three-month follow-up (T2)
|- Trial web site||http://www.vrmentalhealth.nl|
|- CONTACT FOR PUBLIC QUERIES|| W.A. Veling|
|- 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).|
|- Brief summary||People with psychotic disorders commonly have deficits in social cognition and social functioning. Social cognition training (SCT) has been shown to have beneficial effects on social cognition tasks. However, previous studies have shown that remediation of (social) cognitive skills is most likely to be effective if it is optimally integrated with participants' daily lives. Current SCT stimuli may not sufficiently resemble real life, as patients cannot practice skills in dynamic social interactions, which could be solved by providing SCT in Virtual Reality (VR). VR allows for practice of skills in situations resembling real life, yet is safe and controllable. Our aim is to test the efficacy of this VR SCT by conducting a randomized controlled trial (RCT) with two groups: a VR SCT group and an active control group (Virtual Reality relaxation: VRelax). Data on outcome measures is collected at baseline, post-treatment and 3-month follow-up. We will recruit people diagnosed with a psychotic disorder who have deficits in social cognition (as indicated by a clinician), aged 18-55, from participating mental health institutions. The VR SCT consists of sixteen 45 to 60-minute sessions, during an 8-week timeframe. During sessions, social cognition is trained in virtual environments. The intervention consists of three modules: facial affect recognition (1), social perception & theory of mind (2), and social interaction training (3). VRelax consists of an equal number of sessions of equal duration, but features watching relaxing videos in VR. The primary outcome measure is social cognition, as measured on conventional social cognitive tests. Our secondary outcome measure is social functioning and participation, measured using both questionnaires and experience sampling, i.e., participants are prompted to answer questions about their (experience of) (social) activities ten times a day. Participants will be tested at baseline, post-intervention and follow-up, with an average total duration of approximately 2-2.5 hours for each measurement. The intervention will take sixteen hours in total (sixteen sessions of 60 minutes each). We expect participants in the VR SCT group to benefit from the therapy by enhancing social cognition. Participants in the VRelax group may experience a decline in anxiety and stress. Some participants might experience simulator sickness symptoms during the therapy. No major adverse events are expected or have been documented.|
|- Main changes (audit trail)|
|- RECORD||5-dec-2017 - 14-dec-2017|
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