The effect of Virtual Reality Exposure Therapy (VRET) on social participation in people with a psychotic disorder: a multi-site randomized controlled trial.

A large number of patients with a psychotic disorder live a life of limited
participation in society, even if their psychotic symptoms have been treated
successfully. An important factor in sustaining social isolation is that when
social anxiety and distrust increase, the patient has learned to flee the
situation and as a consequence experiences a reduction in anxiety. This is a
form of conditioned avoidance that doesn*t show reduction as an effect of
antipsychotic medication. The evidence based psychological treatment for
experiencing fear and paranoia in social situations is cognitive behavioral
therapy (CBT) with exposure in vivo. This form of treatment in vivo has its
limitations. First limitation is the lack of control over the real social
environment. A second limitation is that exposure in vivo is expensive and not
readily available in most Dutch mental healthcare institutes. Third limitation
is that not al patients find exposure in vivo an acceptable form of treatment
and either not seek treatment or drop-out when they learn what exposure
entails. Virtual Reality Exposure Therapy (VRET) is an evidence based treatment
for several anxiety disorders. It has the potential to be an affordable and
accessible form of treatment to enhance social participation and wellbeing for
patients suffering from a psychotic disorder and social withdrawal. In the
virtual world, fear is experienced similar to the in vivo experience, though at
the same time patients know they are using a computer simulation while safe in
the therapist*s room.

The objective of the study is to determine if virtual reality exposure therapy
(VRET) is an effective treatment for enhancing social participation in people
with a psychotic disorder or generalized social anxiety disorder. The primary
objective is to determine the effect of VRET on social participation. Secondary
objectives are to research the acceptability of VRET for patients and
therapists, and to explore the influence of emotional factors as stigmatization
and depression on social participation.

Single blind randomized clinical trial with 3-month follow-up.

VRET treatment has a maximum of sixteen treatment sessions with a maximum of 60
minutes each. Existing CBT protocols will be adapted for VRET treatment in one
area only: exposure in vivo will be replaced by virtual reality exposure. The
rest of the treatment protocol will consist of well known, evidence based, CBT
elements such as; providing treatment rationale, behavioral experiments,
reducing safety behavior and attention training. Starting with exposure
exercises for social situations lowest in patients anxiety hierarchy, followed
by more anxiety provoking situations, will be the procedure in the VRET
treatment. The exposure exercises will take place during the therapy session
using the Virtual Reality system.

The patients will be interviewed and tested at 3 times (T0, T3, T6). This will
take approximately 3 hours. The other tests (T1, T2) will be administered
during appointed sessions. The patients will have a maximum of 16 sessions,
with a maximum duration of 60 minutes each, during a 8-week timeframe. We
expect patients to benefit from the therapy. We expect therapy to decrease
social anxiety and paranoia and to increase
social participation for patients. It is possible some patients may experience
simulator sickness symptoms during VRET. No major adverse events are expected
or have been documented.