The primary objective of the VRAPT Arousal Pilot Study is to explore the feasibility, appropriateness and acceptability of the developed VRAPT Arousal intervention among forensic psychiatric inpatients and forensic healthcare practitioners working…
ID
Source
Brief title
Condition
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study parameter is the experience with the VRAPT-Arousal module.
This study parameter is measured using both qualitative and quantitative
measures. Qualitative data will be collected through semi-structured
interviews, while the quantitative measure is composed of the Session Rating
Scale (SRS; Duncan et al., 2003).
Secondary outcome
The secondary study parameters entail biomarker data from the wearable that
patients wear during sessions, combined with the data from the Anger Bodily
Sensations Questionnaire (ABSQ; Zwets et al., 2014) and the Multidimensional
Assessment of Interoceptive Awareness (MAIA; Mehling et al., 2018). This data
will be used to investigate the validity of using the Nowatch wearable as a
measurement device for arousal and its corresponding biomarkers (skin
sympathetic nerve activity and heart rhythm).
Background summary
Aggression in forensic psychiatry is common. One of the ways in which the
origins and expression of aggression and aggressive behavior are being
described, is the General Aggression Model. One of the aspects that affect the
response and therefore aggressive behavior is arousal. Arousal, as stated
above, refers to the body*s adaptive responses to environmental stimuli,
altering physiological states to facilitate the recognition and regulation of
emotions. Problems with emotion regulation or appraisal of arousal thus result
in problematic responses, often aggressively. Reducing aggressive behavior
necessitates a different appraisal of situations or social interactions. This
current pilot study specifically focuses on arousal.
Study objective
The primary objective of the VRAPT Arousal Pilot Study is to explore the
feasibility, appropriateness and acceptability of the developed VRAPT Arousal
intervention among forensic psychiatric inpatients and forensic healthcare
practitioners working with forensic inpatients. For the purpose of reaching the
primary objective, several research questions have been posed:
- Does the content of the VRAPT Arousal module align with its proposed goals?
- How satisfied are patients with the design of the module?
- What are the experiences with VRAPT Arousal of patients, trainers and social
workers?
The secondary objective of the VRAPT Arousal Pilot Study is to explore the
feasibility, appropriateness and acceptability of the use of a wearable during
the VRAPT Arousal intervention among forensic psychiatric inpatients and
forensic healthcare practitioners working with forensic inpatients. The
wearable is used for two interrelated purposes: 1) to measure biomarkers during
the sessions, which will aim to give a more objective measurement of arousal
through heart rate variability and skin conductance, and 2) to provide
real-time biofeedback to the patient during various therapeutic exercises of
the VRAPT Arousal intervention.
For the purpose of reaching the secondary objective, several research questions
have been posed:
- Does the Nowatch generate sufficiently valid data (skin conductance and heart
rate variability) that provides insight into bodily arousal?
- To what extent does the arousal measured by the wearable align with the
self-reported arousal of the patient?
- To what extent is an increase in arousal/biomarkers measured by the wearable
during sessions?
- Does baseline arousal decrease over time throughout the sessions?
- To what extent is a patients* ability to recognize bodily sensations
associated with their participation in the Arousal module, and how does
biofeedback data correspond with self-reports?
Study design
To get insight into the acceptability and feasibility of the arousal module, a
mixed methods data collection will be carried out, in two phases. In the first
phase, focus groups will be carried out to see to what extent the health care
professionals are able to perform the module adequately, whilst taking the
intended goals of the intervention into account. In the second phase, a pilot
intervention will be carried out with patients from FPC *de Kijvelanden*. We
aim to include six to ten patients. These patients will receive the newest
version of the VRAPT-Arousal module. After finishing the intervention, these
patients will also be invited to a semi-structured interview to evaluate their
experiences with the module.
Intervention
This research has initiated the development of a new, modular version of VRAPT.
Within the scope of the present study, the feasibility of the first module -
VRAPT Arousal - is studied. All patients in this study will receive a training
using Virtual Reality Aggression Prevention Training (VRAPT) Arousal module.
Treatment duration is 10 weeks with a weekly VRAPT-Arousal session.
Study burden and risks
Patients will complete two questionnaires before starting the intervention.
During the training sessions, patients will wear the Nowatch wristband, which
measures biomarkers (skin sympathetic nerve activity and heart rhythm).
Participants receive weekly VRAPT-Arousal, which consists of 10 sessions in
total, of approximately 45 minutes to 60 each over 10 weeks. The VRAPT-Arousal
module treatment is not yet part of the standard treatment for aggressive
behaviour in a Forensic Psychiatric Centers (FPC) and will be an addition to
the regular treatment program. The main goal of VRAPT-Arousal module is to help
patients recognize arousal and manage potentially (upcoming) escalating
(social) situations more effectively. We expect patients to benefit from the
training, as VRAPT-Arousal provides tools designed to improve their arousal
regulation in high-stress and escalating situations. In combination with other
VRAPT modules, we expect a reduction in aggressive behaviour. This approach
alligns with the main goal of admission to a high security FPC to reduce future
violent recidivism. VR is a safe and controlled way to expose forensic
inpatients to social stimuli (Klein Tuente et al., 2020). There is a small
chance that patients may experience temporary *cyber sickness* (such as
sweating and dizziness) during the VR training. No severe side effects of VR
are known (La Viola, 2000) nor have been documented in previous studies.
Therefore, no major adverse events of VRAPT-ID are expected.
Warandelaan 2 Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2 Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
- 18 years of age and older.
- Forensic psychiatric inpatient in FPC *De Kijvelanden'.
- The presence of aggression regulation problems.
- Convicted to TBS for a violent crime.
- Referred to aggression prevention training by their head of treatment.
- Understanding of Dutch language.
Exclusion criteria
- Active use of narcotics.
- Experiencing an active psychotic episode.
- (history) of epilepsy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL88100.028.24 |