Condition category
Mental and Behavioural Disorders
Date applied
04/08/2014
Date assigned
08/09/2014
Last edited
15/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

http://www.fondsnutsohra.nl

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

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26762123

Publication citations

Additional files

Editorial Notes

15/01/2016: Publication reference added.