Virtual Reality Exposure Therapy in Psychosis
| ISRCTN | ISRCTN12929657 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12929657 |
| Secondary identifying numbers | 001 |
- Submission date
- 04/08/2014
- Registration date
- 08/09/2014
- Last edited
- 06/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
van der Boechorststraat 1
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0) 64 578 04 63 |
|---|---|
| m.vander.gaag@vu.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | VRET.P |
| Study objectives | 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(s) | Medical Ethical Committee of VU Medical Center; 06/03/2014; NL45965.029.13 / 2014.015 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2014 |
| Completion date | 31/12/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Total final enrolment | 116 |
| Key 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) |
| Key exclusion criteria | 1. IQ under 70 2. Insufficient command of the Dutch language 3. Epilepsy |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
1081 BT
Netherlands
Sponsor information
Other
Amstelplein 6
Amsterdam
1096 BC
Netherlands
| Phone | +31 (0)20 594 96 90 |
|---|---|
| info@fondsnutsohra.nl | |
| Website | http://www.fondsnutsohra.nl |
"ROR" |
https://ror.org/04ev7sy32 |
Funders
Funder type
Other
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- NutsOhra Foundation, NutsOhra Fund, Stichting Nuts Ohra
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/01/2016 | Yes | No | |
| Results article | cybersickness results | 01/03/2018 | 18/02/2019 | Yes | No |
| Results article | main results | 01/03/2018 | 18/02/2019 | Yes | No |
| Results article | cost-effectiveness results | 05/05/2020 | 06/05/2020 | Yes | No |
Editorial Notes
06/05/2020: Publication reference and total final enrolment added.
18/02/2019: Publication references added.
15/01/2016: Publication reference added.
