No registrations found.
ID
Source
Brief title
Health condition
Psychosis (psychotic disorder).
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility and acceptability of the therapy (flow chart including the amount of patients that were invited to participate, the amount of patients that decided to participate, and reasons for not participating, drop-out and adherence rates). Also input from therapists and participants (questions about the length of sessions, order and structure of modules, exercises, time spent in VR, acceptability, process of change, barriers and suggestions for further improvement etc.).
Secondary outcome
Sensitivity to change of suitable outcome measures: quantity and quality of social contacts, (leisure) activities and participation in daily life (measured with Experience Sampling Method [ESM]), level of functioning and determinants of social interaction difficulties (measured with questionnaires and interviews).
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 interaction difficulties. A novel VR treatment for this problem has been developed (VR-SOAP). The objective of this study is to pilot this novel VR treatment for social interaction difficulties in preparation of a subsequent randomized controlled trial (RCT). The aim of the study is threefold: 1) to determine 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. This study is a pilot study with a pre-test-post-test quasi-experimental design. Six patients will be included in the study.
Study objective
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. This impairment in social functioning can result in a lower quality of life and insecurity about the future. Current treatments have only moderate effects on social functioning. Virtual Reality (VR) has a great potential to improve training of social interaction difficulties. Therefore, we developed a new Virtual Reality intervention (VR-SOAP) for enhancing the social contacts, leisure activities and social participation of young people with psychosis. VR-SOAP is expected to be accepted by therapists and patients and that the treatment is feasible. This study aims to test this hypothesis.
Study design
All measures will be administrated at baseline (T0) and post-treatment (T1).
Intervention
VR-SOAP consists of 14 weekly sessions (60 minutes) focused on enhancing the quantity and quality of social contacts, leisure activities and participation of young people with a psychotic disorder. VR-SOAP has four optional modules (1-4) and one fixed module (5). In session 1-2 the patient and the therapist discuss the baseline assessment summary and formulate goals concerning social contacts, leisure activities and/or social participation. At the end of session 2, VR-SOAP is introduced. Patient and therapist select two out of four optional VR modules (four sessions each), depending on the perceives causes of the social interaction difficulties and the patient’s goals: Negative symptoms (1), Social cognition (2), Paranoid ideations and Social anxiety (3), Self-esteem and Self-stigma (4). All patients will end with the Communication and Interaction skills module (5, 4 sessions), in which experiences, knowledge and skills from the other modules are integrated and applied.
Dauw Catharina Muijsson
050 - 3615114
d.c.muijsson@umcg.nl
Dauw Catharina Muijsson
050 - 3615114
d.c.muijsson@umcg.nl
Inclusion criteria
DSM-5 diagnosis of schizophrenia spectrum or other psychotic disorder (1). Reduced quantity or quality of social contacts, leisure activities or social participation, according to treating clinician and/or patient (2). Age 18-35 (3).
Exclusion criteria
Estimated IQ ˂70, according to the treating clinician (1). Insufficient command of the Dutch language (2). (Photosensitive) epilepsy (3).
Design
Recruitment
IPD sharing statement
Plan description
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 |
---|---|
NTR-new | NL8741 |
Other | METc UMCG : METc 2019/562; ABR NL71197.042.19; UMCG 201900610 |