Virtual Reality Aggression Prevention Training in forensic clinics

A majority of patients staying in Forensic Psychiatric Centers (in Dutch:
FPC's), Forensic Psychiatric Clinics (in Dutch: FPK's) or Forensic Psychiatric
Departments (in Dutch: FPA*s) are admitted under the judicial measure TBS-order
(terbeschikkingstelling: this translates as *detained under a treatment
order*). A TBS-order is imposed by court on offenders who have committed a
serious violent offense and are considered to be at high risk for re-offending
and who have diminished responsibility for the offense because of severe
psychopathology. Besides being perpetrators of aggression, forensic patients
are also frequently victimized by aggressive behavior of fellow patients.
Standard aggression regulation training follows a cognitive behavioral therapy
(CBT) approach. Effects in forensic settings are small, because possibilities
for controlled exposure to real-life provocation and practicing new behavior
are limited. In this study, a Virtual Reality Aggression Prevention Training
(VRAPT) is developed. VRAPT offers an interactive three-dimensional virtual
*real-life* world in which social situations and interactions can be
experienced and practiced. In a randomized controlled trial, the effect of
VRAPT (intervention-condition) compared to waiting list (control-condition) is
investigated.

Primary objective
The main objective of this study is to examine whether Virtual Reality
aggression prevention training (VRAPT) is effective in reducing aggression and
victimization among inpatient forensic psychiatric patients. This is assessed
using the social dysfunction and aggression scale (SDAS; Widstedt et al., 1990)
on a weekly basis for all forensic psychiatric patients at their ward.
Participants in the VRAPT condition (intervention group) will be compared with
the participants on the waitlist (control group).

Secondary objective
The effect of VRAPT on individual factors as arousal, coping and the way a
patients reacts to provocation is measured in an objective way by using
physiological measurements: electrocardiogram (ECG), electromyography (EMG) en
galvanic skin response (GSR). Again, participants in the VRAPT condition
(intervention group) will be compared with the participants on the waitlist
(control group). Furthermore, participants individual progress can be
measured, by the use of their own physiological measurements at different
moments during the study.

Additionally, the effect of VRAPT on individual self-report measures of
aggression, anger and impulsivity shall be examined. This will be done on three
moments in time, namely: before treatment start, end of treatment and at 3
months follow-up. Firstly, the Buss-Durkee Hostility Inventory-Dutch (BDHI-D;
Lange, Pahlich, Sarucco, Smits, Dehghani, & Hanewald, 1995) will be used to
measure two factors of aggression: overt of direct aggression (20 items) and
covert or indirect aggression (20 items) rated on a *true*- *not true*
dichotomous scale (Lange, Hoogendoorn, & Wiederspahn, 1995). The combination of
verbal and physical aggression represents direct aggression, whereas hostility
and anger are the core concepts of indirect aggression. Secondly, the
State-Trait Anger Expression Inventory-2 (STAXI-2; Hovens, Lievaart & Rodenurg,
2014) is used to measure the experience, expression, and control of anger. The
STAXI-2 is a reliable and valid 57-item measure with scales developed to assess
anger as situational anger (state anger scale), a dispositional characteristic
(trait anger scale), and the expression of anger (anger expression scale)
(Spielberger, 1999; Spielberger & Sydeman, 1994). Thirdly, the Barratt
Impulsiveness Scale (BIS-11; Patton, Stanford & Barratt, 1995) is a
gold-standard 30-item measure that has been influential in shaping current
theories of impulse control, and has played a key role in studies of
impulsivity and its biological, psychological, and behavioral correlates
(Reise, Moore, Sabb, Brown, & London, 2013). The BIS-11 has three subscales,
namely: attentional impulsiveness, motor impulsiveness and non-planning
impulsiveness. Participants in the VRAPT condition (intervention group) will be
compared with the participants on the waitlist (control group). Fourthly, the
Dutch version of the Aggression Questionnaire (AVL; Meesters, Muris, Bosma,
Schouten, & Beuving, 1996) is used. This questionnaire is based on the fact
that the personality trait of aggression consists of four subtraits. Namely,
physical aggression, verbal aggression, anger and hostility (Buss & Perry,
1992). Fifthly, the Novaco Anger Scale and Provocation Inventory (NAS-PI;
Novaco, 1994) is a two-part test of 73 items designed to assess anger as a
problem of psychological functioning and physical health and to assess
therapeutic change (Novaco, 1994). Lastly, to see whether there is
re-victimization involved, the Child Trauma Questionnaire-Short Form (CTQ-SF;
Bernstein & Fink, 1998) is used to measure childhood neglect and abuse, which
are predictive factors for victimization and being a perpetrator in adulthood
because of disturbed (cognitive) emotion regulation (Kamperman, Henrichs,
Bogaerts, Lesaffre, Wierdsma, Ghauharali et al., 2014).

The study consists of three phases.
Phase 1: VRAPT treatment protocol and software will be developed (current -
August 2016)
Phase 2: VRAPT will be tested in a pilot (September 2016 - December 2016)
Phase 3: the effectiveness of VRAPT is investigated in a cluster
randomized controlled trial (RCT; February 2017 - August 2018)

Phase 1 development of VRAPT protocol
Software for VRAPT will be developed by TU Delft (TUD) and CleVR. CleVR is a
company specialized in VR applications for psychiatric disorders. TUD will
develop markers of fear and anger related aspects of behavior on the basis of
the available sensors (GSR, ECG, EMG, Kinect). The scientific and engineering
challenge here is to observe and identify behavior of the patient as fearful or
aggressive as well as identify by which means (posture, body movements, voice,
gestures) this behavior is displayed. Based on this information, the VRAPT
system and therapist have to determine the appropriate responses of the avatar
that the patient is exposed to (responsibility of UMCG and TiU). Virtual
environments used in our other, ongoing projects (Veling et al., 2014) will be
used as a basis for VRAPT. In the developmental phase, a panel of forensic
psychiatric patients and therapists will be asked to comment on concepts,
content, interface and user friendliness of possible solutions. The protocol
will be made in an iterative process. A pilot study with 3-5 patients will be
conducted when the VRAPT protocol is ready. Changes will be made to the
protocol based on experiences in the pilot study.

Phase 2 Pilot
To test the feasibility of VRAPT a pilot study will be conducted in the three
participating centers, namely: FPC van Mesdag, FPC de Kijvelanden and FPC
Pompestichting. In each clinic 4 patients and 5 therapists will participate.
This means in total 12 patients 15 and therapists will be involved in the
pilot.

Phase 3 Effect evaluation
The effect study will be a single blind randomized controlled trial with two
conditions: VRAPT (intervention-condition) and waiting list
(control-condition). The intervention and control conditions are compared 3
months before treatment, at the start of treatment, during treatment and 3
months after the end of treatment. The waiting list condition will receive
VRAPT treatment after 3 months.

VRAPT has a maximum of 16 training sessions of 60 minutes. The therapists
receive 16 hours of training in the protocol; all sessions are recorded. Topics
in VRAPT are based on evidence-based elements of existing aggression regulation
trainings, such as emotional self-management, interpersonal skills and social
problem solving (McGuire, 2008). All sessions lead to and center around Virtual
Reality exposure. The procedure in the VRAPT sessions will follow a gradual
exposure paradigm, starting with exposure exercises for social situations with
the lowest risk for victimization, followed by situations where aggression is
increased. Exercises include both situations with aggressive other persons and
situations provoking aggression in patients. The exposure exercises will take
place during the therapy sessions, using the Virtual Reality system.

Forensic psychiatric inpatients will be tested at 3 times, this will take
approximately 1 hour. The other tests 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 training. We expect training to decrease both victimization and
aggression. It is possible some patients may experience simulator sickness
symptoms during VRAPT. No major adverse events are expected or have been
documented.