Primary ObjectiveIn preparation for a multicentre RCT we want to test the VR SCT for people with psychotic disorders in a feasibility study. We want to evaluate the feasibility and acceptability of VR SCT and improve the intervention protocol using…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main goal of the pilot trial is to evaluate the feasibility and
acceptability of the intervention and to evaluate and improve the intervention
protocol. We will use feedback sessions questionnaires (completed by the
therapist after each session) and post intervention evaluation questionnaires
(for participants and for therapists), consisting of both quantitative and
qualitative ratings to inquire about the intervention experience (e.g., was the
treatment helpful, was it tolerable, was the number, frequency and duration of
sessions appropriate). The following aspects will be examined with the
questionnaires:
General
- Attrition rates
Participants
- Satisfaction with number and intensity of sessions
- Satisfaction with content of sessions
- Difficulty level appropriateness
- Satisfaction with VR technology (e.g., software and hardware)
- Experience (e.g., realism) of VR environments, avatars and narratives
- Strength of therapeutic alliance
- Subjective experience of training (e.g., helpfulness of training,
applicability in daily life)
- Advantages and disadvantages of current approach
Training
- Protocol fidelity
- Satisfaction with number and intensity of sessions
- Satisfaction with content of sessions
- Difficulty level appropriateness
- Satisfaction with VR technology (e.g., software and hardware)
- Experience (e.g., realism) of VR environments, avatars and narratives
- Strength of therapeutic alliance
- Subjective experience of training (e.g., helpfulness of training,
applicability in daily life)
- Advantages and disadvantages of current approach
Secondary outcome
To explore the efficacy of the intervention, we will examine the effect of VR
SCT on several domains (see table 1 for an overview), as well as behaviour and
performance during VR SCT (see table 2 for an overview).
Diagnostic Measures/ Symptoms
- Mini International Neuropsychiatric Interview Plus (MINI-plus): A structured
clinical interview, used to determine diagnoses. Used to verify PD status if a
diagnosis has not been verified in the past three years.
- Positive and Negative Syndrome Scale (PANSS): The PANSS is a semi-structured
interview which uses self-report information and observation to assess positive
symptoms (7 items), negative symptoms (7 items), and general psychopathology
(16 items).
- Social Interactin Anxiety Scale (SIAS): Measures social anxiety verbally and
non-verbally with a 20 item questionnaire
- Beck Depression Inventory (BDI): Measures the severity of depression with a
questionnaire.
- Green Paranoid thought Scale (GPTS): Measures two dimensions of paranoid
thinking with a 20 item questionnaire: ideas of social reference and ideas of
social persecution.
Emotion Perception
- Bell-Lysaker Emotion Recognition Task (BLERT): An computerized affect
recognition task to assess differentiation between six basic emotions in others
(happiness, anger, disgust, sadness surprise and fear). Participants are shown
video vignettes in which an actor expresses one of the six basic emotions and
asked which emotion they recognize.
- Facial Expression of Emotion: Stimuli and Tests (FEEST): A computerized test
which consists of 60 pictures portraying basic emotions (anger, disgust, fear,
happiness, sadness or surprise), which the participant has to identify.
- Empathic Accuracy Task (EAT): This task consists of ten videos of people who
discuss an autobiographical emotional event. Each person depicted in the videos
has watched their own video and continuously rated their emotions while telling
the story on a 9-point scale. The participant has to rate the mood of the
person in the video continuously on a 9 point scale. These two ratings are
correlated to provide an index of empathy.
Theory of Mind
- The Awareness of Social Inference Task III (TASIT): Video vignettes of
everyday social interactions. Assesses detection of lies, sarcasm,
understanding of intentions and beliefs.
- Faux Pas Test (FP): administered to assess participants* ability to
understand others* perspectives, thoughts and feelings, and recognition and use
of social rules. Ten stories are read to the participant, of which five contain
a *faux pas* (breach of social rules). Participants are asked to indicate
whether a faux pas has occurred and if so, what, who, and why. Two additional
questions are asked to assess empathy (how is X feeling) and comprehension (a
factual detail from the story).
Social Functioning
- Personal and Social Functioning Scale (PSP): structured interview which
inquires about various domains of daily life functioning (e.g., work,
friendships, self-care).
Neurocognition
- Trailmaking Test (A and B) (TMT-A&TMT-B): To assess processing speed (TMT-A)
and mental flexibility (switching between two mindsets; TMT-B). In this task,
numbers (TMT-A) or numbers and letters (TMT-B) are printed in circles,
scattered across a page. Participants connect these numbers in correct order
(TMT-A). In TMT-B, participants also have to concurrently connect letters in
alphabetical order (i.e., 1-A-2-B-3-C-4-D etc).
- Nederlandse leestest voor volwassenen: measures premorbid intelligence level
(IQ).
- Rapid visual information processing: a sensitive measure of sustained
attention. Outcome measures for this test include response accuracy, target
sensitivity, and reaction times.
Simulator sickness questionnaire (SSQ)
-Measures simulator sickness on symptom level, is administered before and after
the VR exposure.
Eye Tracking
- The Oculus Rift DK2 virtual reality headset used in this study has an
integrated eye tracking system ( the Eye Tracking Upgrade Package of
SensoMotoric instruments (SMI) ) which. The SMI eye tracker delivers eyeball
position, gaze vectors and size values for both eyes at 60Hz, fixation and
saccades can be determined.
Heart Rate
- Hearth rate variation will be measured by electrocardiogram (ECG).
Manipulation check
A manipulation check at the end of the first VR session will assess basic
memory encoding of the scenes as included in the VR exposure (i.e., scene
feature recall and spatial and temporal ordering of the features depicted in
the scenes and emotional reactions during the exposure (i.e., state anxiety and
dissociative experiences).
- State Anxiety Inventory (SAI): State anxiety will be assessed with the State
Anxiety Inventory. The SAI reflects one half of the State-Trait Anxiety
Inventory and contains 20 items measuring current anxiety level. Responses to
each item range from 1 (not at all) to 4 (very much so). Overall scores range
from 20 to 80, and the higher the score, the greater the level of anxiety. This
measure was selected due to its psychometric properties and pragmatic value and
to assess the degree participants experienced state anxiety during the VR
exposure.
- Clinician Administered Dissociative States Scale (CADSS): The CADSS measures
state dissociation was developed to assess alterations in levels of state
dissociation in a clinical population. Twenty-three self-report items are
scored on a 5-point scale ranging from 0(not at all) to 4 (extremely). Overall
mean scores range from 0 to 4, with higher scores indicating higher levels of
state dissociation, including the symptom areas depersonalization,
derealization, and amnesia. The CADSS self-report items have satisfactory
reliability and validity.
- Feature binding: Scene feature recall and spatial and temporal ordering of
the features depicted in the scenes will be assessed with a free recall task
and a relocation task. Virtual scenes from the VR exposure session will be
played back to the participants and they will be asked to indicate the correct
temporal order of the scenes and relocate specific features (e.g., avatars) in
the correct spatial location within a given scene (Kessels, Postma, & de Haan,
1999).
Background summary
Rationale: People with psychosis commonly experience deficits in social
cognition and social functioning. Social cognition training (SCT) has been
shown to have beneficial effects on social cognition tasks, but generalization
to social functioning in daily life is limited. Current SCT stimuli do not seem
to be ecologically valid, and patients cannot practice skills in dynamic social
interactions. We propose that this problem 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. We want to pilot this new intervention
in preparation for a randomized controlled trial (RCT).
Objective: The primary objective is to determine the feasibility and
acceptability of VR SCT in people with psychotic disorders. Secondarily, we
want to study behavior during VR SCT and explore the effect of VR SCT on
behaviour, social cognition and physiological measures.
Study design: This study is a pilot study with a patient group with a psychotic
disorder (PD) and a healthy control group (HC). PD will receive the
intervention, baseline and post-intervention assessment will be obtained. HC
will perform a baseline measure.
Study population: PD consist of 25 individuals with a psychotic disorder and
social cognition problems, age 18-65, recruited from the department of
psychiatry of the UMCG and GGZ Drenthe. Twenty-five HC, age 18-65, will be
recruited from employees of the UMCG and the University of Groningen.
Intervention: The VR SCT consists of sixteen sessions, which last 60 minutes
each during an 8-week timeframe. During sessions, participants explore virtual
environments developed to train social cognitive skills. The intervention
consists of three modules: facial affect recognition, emotion recognition
within a context, and theory of mind & interaction training.
Main study parameters/endpoints: Primary outcome: Acceptability, utility and
feasibility of the intervention, measured using questionnaires and interviews.
Secondary outcome: social cognition, neurocognitive and psychophysiological
outcome measures.
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: PD will be interviewed and tested at baseline
and post intervention, with an average total duration of approximately three
hours for each measurement. The intervention will take sixteen hours in total
(sixteen sessions of 60 minutes each). We expect patients to benefit from the
therapy by increasing social cognitive skills. Some patients might experience
simulator sickness symptoms during the therapy. No major adverse events are
expected or have been documented. HC will perform the baseline measure which
will take approximately 3 hours in total and one VR SCT session of 60 minutes.
Study objective
Primary Objective
In preparation for a multicentre RCT we want to test the VR SCT for people with
psychotic disorders in a feasibility study. We want to evaluate the feasibility
and acceptability of VR SCT and improve the intervention protocol using input
from experts and participants experience.
Secondary Objective
To explore suitable outcome measures and the effects of VR SCT on social
cognition, physiological measures.
To study behaviour and physical measures (e.g. interpersonal distance, eye
movement and hearth rate) during VR SCT in healthy controls (HC) and patient
with a psychotic disorder.
Study design
This pilot study will be a clinical trial with an experimental group of
individuals with a psychotic disorder group (PD) and HC. PD receive the VR SCT
intervention and they will complete a baseline and post-intervention
assessment.
HC only have one assessment (no intervention). During this measurement baseline
tasks similar to PD baseline tasks will be assessed and in addition one session
of VR SCT will be completed. During this session data of HC is collected on
heart rate, eye tracking and performance on emotion recognition. This data is
necessary to establish watching behaviour, hearth rate and emotion recognition
performance in HC because no reference data of healthy people is available yet
for VR SCT tasks.
Intervention
Virtual Reality set-up
Virtual environments have been developed with Unity3D software by CleVR BV. VR
is offered using the Oculus Rift HMD (first consumer version) with a resolution
of 1080x1200 per eye, with 110 degrees diagonal Field of View, and build in
6-DOF (Degrees of Freedom) tracking. Participants can move through virtual
worlds using a joystick. The built-in tracker responds to the participant*s
head movements, showing them in the virtual world (e.g., if the participant
looks down in real life, their gaze in the virtual world will be shifted
downward as well). The therapist controls this PC and the VR software. He or
she is at all times in control of the VR intervention, and able to change or
stop the virtual environment immediately if necessary. The VR program that is
currently in use can project four different virtual environments: a bus, a
shopping street, a store and a café. The therapist can control the content of
the virtual environment in several ways, e.g., the amount of avatars walking
around, the emotions that they show and the level of difficulty of exercises.
VR SCT
The SCT consists of sixteen sessions, which last 60 minutes each. During these
sessions, PD participants 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 behaviour of the participant in the virtual environment and
provide feedback on the utility and functionality thereof (e.g., gaze,
interactive behaviours). 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).
The intervention consists of three modules: facial affect recognition, emotion
recognition within a context, and theory of mind & interaction training.
1. Facial affect recognition training. 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. In the FAR training, we will expose patients to
facial emotions and train them in emotion recognition, starting with basic
emotions in a one-on-one standing situation, and gradually increasing
difficulty, allowing them to practise: mixed and subtle emotions; more avatars
simultaneously; walking and talking avatars; and complex, distracting
situations in which facial emotions should be recognized quickly.
2. Emotion recognition within contexts. The general aim of this module is
similar to the first, but in this part of the training, emotions will be placed
into narratives. These narratives are provided by pre-written scenarios that
are structured as a data tree.
Participants start in a basic scenario. Making a choice or giving an answer to
a quesiton results in the selection of one of the data branches. If an
inappropriate or incorrect answer is chosen, participants are given hints (e.g.
exaggerated emotions or statements that convey emotional information more
clearly) and given another opportunity to provide an answer. Thus, the flow of
the narrative is dependent on the choices made by the participant, in order to
make the training more naturalistic and interactive and tailored to the
capacities of the participant. The questions that are asked and the answers
will be presented and answered within the VR environment, to preserve a sense
of immersion and presence in the virtual world.
3. Theory of Mind & interaction training. The goal of this module is for
participants to learn to interpret the motivations, thoughts, intentions and
implied meanings of the avatars. As in the second module, participants will
encounter scenarios involving the avatars. In module 3, the emphasis is thus no
longer on recognizing emotions but rather understanding the mental states
underlying them. Another important difference is that in module 3, participants
are no longer passive spectators: they engage in interactions with the avatars.
If a mental state is misunderstood, avatars will give more obvious hints;
correct answers are *rewarded* with positive reactions from the avatars. For
example, if a participant reassures an avatar, the avatar may react with
*Thanks, that really makes me feel a lot better* and smile at the participant.
We will use a variety of tree-structure scenarios, including true belief
situations (understanding what another person correctly believes) and false
belief scenarios (understanding that others can have erroneous beliefs about
reality and inhibiting one*s own perspective). For an example of such a
scenario, see Appendix 1. The flow of the narrative is again based on the input
provided by the participant. Participants are allowed to answer freely. In the
data tree, these answers are categorized in a finite amount of descriptions (1:
the participants answers adequately; 2: the participant answers inadequately
(e.g., starts talking about a completely different subject); 3: the participant
barely answers or affectively *flat*, e.g., *I don*t know* or *I don*t care*).
The therapist selects the category that best fits the answer given by the
participant.
Study burden and risks
Some participants might experience mild cyber sickness. Symptoms are similar as
those of motion-induced sickness, but fortunately they tend to be less severe
and have a lower incidence. Some research suggests that the simulator sickness
sensations can be at least partially explained by overlap with anxiety
symptoms, since studies showed no increase of simulator sickness symptoms after
exposure to VR and higher cyber sickness scores in patients with psychosis
before but not after exposure in relation to healthy controls.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for participants with a psychotic disorder:
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
2) Age 18 - 65.
3) Indication of impaired social cognition by the treating therapist;Inclusion criteria healthy controls:
1) Age 18 - 65.
Exclusion criteria
1) An estimated IQ below 70.
2) Substance dependence.
3) Insufficient proficiency of the Dutch language.
4) Presence of a relevant psychiatric or neurological disorder such as autism, dementia, epilepsy or organic brain damage.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL55477.042.16 |