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ID
Source
Brief title
Health condition
Psychotic disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the quantity and quality of social contacts, (leisure) activities and participation in daily life, measured with Ecological Momentary Assessments (EMA).
Secondary outcome
Level of functioning will be assed with the Social Functioning Scale.
Determinants of social interaction difficulties: psychotic, negative, affective and autistic symptoms, stress, self-esteem and self-stigma are assessed with the Positive And Negative Syndrome Scale, Green Paranoid Thoughts Scale, Social Interaction Anxiety Scale, Self-Esteem Rating Scale and the Internalized Stigma of Mental Illness scale. Social cognition is assessed with the hinting task. Communication skills are assessed with the Schaal Interpersoonlijk Gedrag.
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. With VR, individuals can enter personalized simulations of difficult situations and be coached in the appropriate responses. Our group has previously developed VR treatments (VRT) for paranoid delusions, aggression and social cognition. In the current project, these interventions are merged and extended into VRT-SOAP, a VR treatment of 14 sessions, focusing on enhancing quantity and quality of SOcial contacts, leisure Activities and Participation of young people with a psychotic disorder. The VRT-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. After preparation and piloting, a single-blind randomized controlled trial is conducted with 116 participants. VRT-SOAP is compared with VRelax, VR video relaxation in combination with stress management psycho-education. Primary outcome is quantity and quality of social contacts, leisure activities and participation, measured with ecological momentary assessments. The effects of the two conditions are compared at the end of treatment and six months later.
Study objective
VRT-SOAP is an effective treatment for improving quantity and quality of social contacts, leisure activities and social participation in young people with a psychotic disorder
Study design
Pre-assessment (T0), Post-treatment (T1), Follow-up (T2; 6 months). Assesments will be conducted by blind raters.
Intervention
Patients will be randomly assigned to the experimental or active control condition after which they will receive treatment for 14 weeks. This entails the VR-SOAP training or VRelax training.
Inclusion criteria
DSM-5 diagnosis of schizophrenia spectrum or other psychotic disorder, age 18-35, and reduced quantity or quality of social contacts, leisure activities or social participation, according to treating clinician and/or patient.
Exclusion criteria
Estimated IQ <70, insufficient command of the Dutch language.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9784 |
| CCMO | NL69628.042.21 |
| OMON | NL-OMON54752 |