To test the effect of a novel VR treatment for social interaction difficulties (VR-SOAP) on quantity and quality of social contacts, leisure activities and social participation of young people with a psychotic disorder. Furthermore, to investigate…
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is quantity and quality of social contacts, leisure activities
and participation, measured with Experience Sampling Method (ESM). Patients
will complete ESM at semi-random moments, prompted by a signal on their phone
(five times a day during a period of two weeks).
Secondary outcome
Secondary outcome is the level of functioning, measured with SFS. Furthermore,
determinants of social interaction difficulties are measured with PANSS, BNSS,
BLERT, Hinting, GPTS-R, SIAS, SERS-SF, ISMI and DAQ.
Background summary
Young people with a psychotic disorder have the same social goals as their
healthy peers, but their social networks are smaller, they participate less
often in leisure activities and are less successful in work and education.
Causes of these problems are multifaceted, but culminate in difficulties with
interacting in daily life social situations. Current treatments have only
moderate effects on social functioning. Virtual reality (VR) has a great
potential to improve training of social interactions difficulties. We have
developed a VR treatment for this problem. In this study it will be
investigated of this treatment helps.
Study objective
To test the effect of a novel VR treatment for social interaction difficulties
(VR-SOAP) on quantity and quality of social contacts, leisure activities and
social participation of young people with a psychotic disorder. Furthermore, to
investigate the level of functioning and determinants of social interaction
difficulties.
Study design
Single-blind randomized controlled trial with cross-over.
Intervention
VR-SOAP is a VR treatment of 14 weekly sessions, focusing on enhancing quantity
and quality of social contacts, leisure activities and participation of young
people with a psychotic disorder. The VR-SOAP intervention will have four
optional modules (1-4) and one fixed module (5): 1. Neurocognition and negative
symptoms, 2. Social cognition, 3. Paranoid ideations and Social anxiety, 4.
Self-esteem and Self-stigma, and 5. Communication and Interaction skills.
VR-SOAP is compared with VRelax, VR video relaxation in combination with stress
management psycho-education. The VRelax intervention also consists of 14 weekly
sessions.
Study burden and risks
Questionnaires and EMA are used at 3 times (baseline [T0], end of treatment
[T1], six months after start treatment [T2]). The questionnaires will take
approximately 145-155 minutes. Patients will complete the EMA five times a day
during two weeks. The diary will consist of 35 items and will take 3-4 minutes
to complete per assessment (5 x 14 x 3-4 minutes = 210-280 minutes). The
patients will have 14 sessions (maximum 60 minutes), during a 4 month
timeframe. We expect patients to benefit in the VR-SOAP condition. It is
possible some patients may experience simulator sickness symptoms during
VR-SOAP/VRelax. No major adverse events are expected.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
- DSM-5 diagnosis of schizophrenia spectrum or other psychotic disorder.
-Reduced quantity or quality of social contacts, leisure activities or social
participation, according to treating clinician and/or patient.
- Age 18-40
Exclusion criteria
- Estimated IQ *70.
- Insufficient command of the Dutch language.
Design
Recruitment
Medical products/devices used
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No registrations found.
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In other registers
| Register | ID |
|---|---|
| CCMO | NL69628.042.21 |