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ID
Source
Brief title
Health condition
Virtual Reality, Schizophrenia, Psychosis, Cognitive Behavioral Therapy, Exposure Therapy
Virtual Reality, Schizofrenie, Psychose, Cognitieve Gedragstherapie, Exposure Therapie
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is level of paranoid ideations in daily life social situations, measured with ecological momentary assessments (EMA). EMA is a structured diary method in which individuals are asked in normal daily life to report their momentary thoughts, feelings and symptoms, as well as the (appraisal of the) social context.
Secondary outcome
Secondary outcomes include EMA level of social activities, proportion of time spent in social company, levels of distress, anxiety and depression.
Also, questionnaires and interview measures are used to assess paranoid thoughts and paranoid delusions, hallucinations, social anxiety, depressive symptoms, safety behaviors, worry, self-esteem, interpersonal sensitivity, cognitive schemas and cognitive biases. TiC-P and EQ-5D-5L measures are used to calculate cost-effectiveness and cost-utility.
In order to test differences between VRcbt and CBT in number of sessions needed to achieve clinically meaningful change, participants will complete short questionnaires on level of paranoid ideation before each session and therapists will rate participants' level of paranoid ideation after each session.
Background summary
Seventy percent of patients with schizophrenia and other psychotic disorders has paranoid delusions. Paranoid delusions are associated with great distress, hospital admission and social isolation.Cognitive behavioral therapy (CBT) is the main psychological treatment, but the median effect size is only small to medium. Virtual reality (VR) has a great potential to improve psychological treatment of paranoid delusions. Preliminary studies suggest that VR based CBT (VRcbt) for paranoid delusions may be more (cost-)effective than standard CBT. The aim of this project is to test this hypothesis.
In a multicenter Randomized Controlled Trial (n=106), this study will investigate if VRcbt is more (cost-) effective than standard CBT for treatment of paranoid delusions and improving daily life social functioning of patients with schizophrenia and related psychotic disorders. In both conditions participants will receive maximum 16 sessions of treatment.
Study objective
Seventy percent of patients with schizophrenia and other psychotic disorders has paranoid delusions. Paranoid delusions are associated with great distress, hospital admission and social isolation. Cognitive behavioral therapy (CBT) is the main psychological treatment, but the median effect size is only small to medium. Virtual reality (VR) has a great potential to improve psychological treatment of paranoid delusions. Preliminary studies suggest that VR based CBT (VRcbt) for paranoid delusions may be more (cost-)effective than standard CBT. The aim of this project is to test this hypothesis.
Study design
All measures will be administered at baseline (T0), after treatment (T3) and 6 months after treatment (T6), by raters who are blind for the treatment allocation of the participants.
Intervention
VRcbt consists of maximum 16 sessions in virtual social situations that trigger paranoid ideations and distress, delivered in an 8-12 week time frame. Standard CBT also consists of maximum 16 sessions, aiming at reappraisal of the meaning of paranoid beliefs to reduce distress and improve coping in daily life, including the use of exposure and behavioral experiments.
Inclusion criteria
- DSM-5 diagnosis of schizophrenia spectrum or other psychotic disorder.
- At least a moderate level of paranoid ideations (GPTS >40).
- Age 18-65
Exclusion criteria
- IQ under 70
- Insufficient command of Dutch language
Design
Recruitment
IPD sharing statement
Plan description
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7758 |
| Other | Medisch Ethische Toetsingscommissie van het Universitair Medisch Centrum Groningen : METc 2018.425; ABR NL66850.042.18; UMCG 201800564 |