The objective of this study is to pilot this novel VR treatment for social interaction difficulties (VR-SOAP) in preparation of a subsequent randomized controlled trial (RCT). The aim of the study is threefold: 1) to investigate the feasibility and…
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 Methods (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 WHO DAS, PSP and
PGGS. Furthermore, determinants of social interaction difficulties are measured
with PANNS, BNSS, AQ, GPTS, SIAS, PSS, SERS, ISMI, BLERT, Hinting Task en SIAS.
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
The objective of this study is to pilot this novel VR treatment for social
interaction difficulties (VR-SOAP) in preparation of a subsequent randomized
controlled trial (RCT). The aim of the study is threefold: 1) to investigate
the feasibility and acceptability of the therapy, 2) to evaluate and improve
the treatment protocol using input from therapists and participants, 3) to
explore sensitivity to change of outcome measures.
Study design
Pilot study with a pre-test-post-test quasi-experimental design.
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 (social functionng). The VR-SOAP intervention
will have four optional modules (1-4) and one fixed module (5): 1. Negative
symptoms, 2. Social cognition, 3. Paranoid ideations and Social anxiety, 4.
Self-esteem and Self-stigma, and 5. Communication and Interaction skills. In
session 1 and 2 (introduction sessions) patient and therapist discuss the
baseline assessment summary and formulate goals with regard to social contacts,
leisure activities and/or social participation. Patient and therapist select
two out of four optional VR modules (4 sessions each), depending on the
perceived causes of the social interaction difficulties and the patient's
goals. All patients will end with the Communication- and interaction skills
module (4 sessions).
Study burden and risks
Questionnaires and ESM are used at 2 times (baseline [T0] and end of treatment
[T1]). The questionnaires will take approximately 165-175 minutes x 2 = 330-350
minutes. Optionally, an additional measurement takes place of approximately 40
minutes x 2 = 80 minutes. Patients will complete the ESM five times a day
during two weeks (T0, T1). The diary will consist of 39 items and will take 3-4
minutes to complete per assessment (5 x 14 x 3-4 minutes x 2 = 420-560
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. 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 18-35.
Exclusion criteria
- Estimated IQ <70.
- Insufficient command of the Dutch language.
- (Photo sensitive) epilepsy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL71197.042.19 |