To 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.
ID
Source
Brief title
Condition
- Schizophrenia and other psychotic disorders
Synonym
Research involving
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) at semi-random moments ten
times a day during seven days, before and after treatment.
Secondary outcome
Mean scores before and after treatment on GPTS, SIAS, PSYRATS, SBQ, PSWQ, SERS,
IPSM, BCSS and DACOBS will be compared between conditions.
Cost-effectiveness analyses (CEA) will be conducted using TiC-P and EQ-5D-5L
questionnaires.
For determining number of sessions needed for achieving clinically meaningful
changes, scores of patients on VAS items (based on GPTS, EMA and ORS), and
scores of therapists on the GCI will be compared per session between
conditions.
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.
Study objective
To 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.
Study design
Single-blind randomized controlled intervention study.
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 with social
situations in daily life, including the use of exposure and behavioral
experiments.
Study burden and risks
Participants will be interviewed and tested at 3 times (T0, T3, T6). This will
take approximately 1.5 hours. They will also complete diary questionnaires 10
times a day during 7 days, which takes 2-3 minutes. Also, self-report
questionnaires (15 minutes) will be administered weekly after appointed
sessions. The patients will have a maximum of 16 sessions, with a maximum
duration of 60 minutes each, during a 8-12 week timeframe. We expect patients
to benefit from the therapy in both conditions. It is possible some patients
may experience simulator sickness symptoms during VRcbt. No major adverse
events are expected or have been documented.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- DSM-5 diagnosis of schizophrenia spectrum or other psychotic disorder.
- At least a moderate level of paranoid ideations (Green Paranoid Thoughts
Scale >40).
- Age 18-65.
Exclusion criteria
- IQ under 70.
- Insufficient command of Dutch language.
- Received Cognitive Behavioral Therapy for paranoid delusions in past 12
months.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL66850.042.18 |