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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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18 May 2020 |
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Main ID: |
ISRCTN12929657 |
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Date of registration:
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08/09/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Virtual Reality Exposure Therapy in Psychosis
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Scientific title:
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The effect of Virtual Reality Exposure Therapy (VRET) on social participation in people with a psychotic disorder: a multi-site randomized controlled trial |
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Date of first enrolment:
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01/04/2014 |
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Target sample size:
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160 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN12929657 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Mark
van der Gaag |
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Address:
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van der Boechorststraat 1
1081 BT
Amsterdam
Netherlands |
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Telephone:
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+31 (0) 64 578 04 63 |
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Email:
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m.vander.gaag@vu.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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)
Exclusion criteria:
1. IQ under 70
2. Insufficient command of the Dutch language
3. Epilepsy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Psychotic disorders with continuing social withdrawal
Mental and Behavioural Disorders
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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)
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Source(s) of Monetary Support
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Fonds NutsOhra (Netherlands)
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Ethics review
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Status:
Approval date:
Contact:
Medical Ethical Committee of VU Medical Center; 06/03/2014; NL45965.029.13 / 2014.015
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2015 |
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URL:
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