Plain English Summary
Background and study aims
Paranoia is a mental condition where a person falsely believes that they are being persecuted by others and is deeply suspicious and mistrustful of those around them. Many paranoid patients live restricted lives; they find relationships difficult due to being so suspicious and unfriendly, suffer from social anxiety and tend to avoid all kinds of social occasions. Here, we want to see whether virtual reality technology helps to make paranoid patients feel more able to go outside and enjoy social occasions.
Who can participate?
All patients that experience fear and avoid going outside or travelling by public transportation, etc.
What does the study involve?
The patients are randomly allocated into one of two groups. Those in group 1 have up to 16 sessions of virtual reality exposure therapy over a 3 month period. Those in group 2 are placed on a waiting list for 6 months, after which they also receive the treatment. The amount of social participation (time spent with other people, including family, friends, colleagues and strangers) and feelings of paranoia experienced in social situations is measured. All participants are assessed at the start of the treatment, at the end of the treatment and 3 months after the treatment has ended.
What are the possible benefits and risks of participating?
There are no known serious risks. Some people feel sick (cyber illness) during the virtual reality exposure.
Where is the study run from?
VU University, Amsterdam (Netherlands) and the Parnassia Psychiatric Institute in the Hague (Netherlands)
When is study starting and how long is it expected to run for?
April 2014 to December 2015
Who is funding the study?
The NutsOhra Foundation (Netherlands)
Who is the main contact?
Professor Mark van der Gaag
m.vander.gaag@vu.nl
Trial website
Contact information
Type
Scientific
Primary contact
Prof Mark van der Gaag
ORCID ID
Contact details
van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
+31 (0) 64 578 04 63
m.vander.gaag@vu.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
The effect of Virtual Reality Exposure Therapy (VRET) on social participation in people with a psychotic disorder: a multi-site randomized controlled trial
Acronym
VRET.P
Study hypothesis
Virtual Reality Exposure Therapy will improve real life social participation in patients with a psychotic disorder experiencing paranoia and/or social anxiety symptoms.
Ethics approval
Medical Ethical Committee of VU Medical Center; 06/03/2014; NL45965.029.13 / 2014.015
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Psychotic disorders with continuing social withdrawal
Intervention
In both arms treatment as usual will be provided for the psychotic disorder for which the person sought help. In the first experimental arm there will be a maximum of 16 sessions (over three months) of Virtual Reality Exposure Treatment with a trained CBT therapist aimed at improving social participation. Treatment duration is three months, patients will be followed-up at 3 months. The second arm entails a waiting list for a period of six month, after which these participants will also get the VRET treatment.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Experience Sampling Method (ESM) on social participation.
2. Objective social participation is expressed as the amount of time spend with other people and the type of company (for example family, friends, colleagues or strangers).
3. Subjective social participation is expressed as momentary paranoia, perceived social threat and event stress as experienced in social situations.
All measures are measured at baseline, at end of treatment at 3 months, and at follow-up at 6 months.
Secondary outcome measures
1. Depression (BDI-II)
2. Stigmatisation and schemata (ISMI, BCSS)
3. Paranoia (GPTS)
4. Social interaction anxiety (SIAS)
5. Cognitive biases (DACOBS)
6. Safety behavior (Safety Behavior Questionnaire persecutory delusions)
7. Quality of life and cost-effectiveness (MANSA,TIC-P)
8. Presence and cyber sickness (SSQ, IPQ), measured at month 1 and at month 2 during treatment.
9. Psychosis (Positive and Negative symptom scales)
10. Social functioning (Social and Occupational Functioning Assessment Scales)
Overall trial start date
01/04/2014
Overall trial end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 to 65 years, either sex
2. Fullfilling diagnostic criteria for a psychotic disorder
3. Experiencing at least mild paranoia and/or social anxiety as measured with the Green et al. Paranoid Thought Scales (GPTS) and Social Interaction Anxiety Scale (SIAS)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
160
Total final enrolment
116
Participant exclusion criteria
1. IQ under 70
2. Insufficient command of the Dutch language
3. Epilepsy
Recruitment start date
01/04/2014
Recruitment end date
31/12/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
NutsOhra Foundation (Fonds NutsOhra) (Netherlands)
Sponsor details
Amstelplein 6
Amsterdam
1096 BC
Netherlands
+31 (0)20 594 96 90
info@fondsnutsohra.nl
Sponsor type
Other
Website
Funders
Funder type
Other
Funder name
Fonds NutsOhra (Netherlands)
Alternative name(s)
Stichting Nuts Ohra, NutsOhra Foundation, NutsOhra Fund
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26762123
2018 main results in http://www.ncbi.nlm.nih.gov/pubmed/29429948 (added 18/02/2019)
2018 cybersickness results in http://www.ncbi.nlm.nih.gov/pubmed/29356575 (added 18/02/2019)
2020 cost-effectiveness results in https://www.ncbi.nlm.nih.gov/pubmed/32369036 (added 06/05/2020)