Clinical trial NCT05293834: Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients
Official title: Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Forensic Psychiatry
Keywords: Aggression Prevention
Virtual Reality
Virtual Reality Aggression Prevention Training (VRAPT)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Psychiatric Clinics Basel
First posted: 2022-03-24
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Violent and aggressive behavior as well as disorders related to aggressive behavior are highly common in both adult and juvenile forensic psychiatric patients, and is also present in a subgroup of non-forensic psychiatric in- and out-patients. One promising new treatment option is Virtual Reality. A newly developed program in this area is the Virtual Reality Aggression Prevention Training (VRAPT). The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss forensic and non-forensic psychiatric setting, including both adult and juvenile patients, and to examine whether VRAPT is an effective treatment method for aggressive behavior.

Detailed description: Violent and aggressive behavior as well as disorders related to aggressive behavior are highly common in both adult and juvenile forensic psychiatric patients, and is also present in a subgroup of non-forensic psychiatric in- and out-patients. In order to minimize the risk for future violent offending it is important to intervene in these high-risk populations. Previous research showed that punishment alone is counterproductive for repeated offending behavior. In contrast, treatment was found to have a positive effect on reoffending (i.e., less reoffending). However, although knowledge about the treatment of (forensic) psychiatric patients has increased significantly in recent decades, it is still not fully understood what works for whom under which circumstances. One promising new treatment option is Virtual Reality. A newly developed program in this area is the Virtual Reality Aggression Prevention Training (VRAPT). This training is currently implemented and examined in correctional and forensic psychiatric facilities in the Netherlands and in Sweden. Results from the first randomized controlled trial (RCT) on the effectiveness of the intervention showed that the VRAPT group showed a decrease in some aggressive behaviors at post-test, but not anymore at 3-month follow-up. The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss forensic and non-forensic psychiatric setting, including both adult and juvenile patients, and to gather information needed for the design of a large, international, high-quality, multicenter RCT. The research questions will address the effect of VRAPT on aggressive behavior, state-trait anger expression, stages of motivational change, emotion regulation, and therapeutic alliance. The present investigation will be the first study to include juvenile forensic psychiatric patients as well as to test VRAPT in Switzerland, thereby increasing the generalizability of the research to other populations. Furthermore, it will be the first time VRAPT will be tested in a non-forensic psychiatric sample exhibiting aggressive behaviour. In addition, it will address problem awareness and therapy motivation as possible factors influencing treatment outcome, and address some of the limitations of previous research.

Eligibility criteria: Inclusion Criteria:

* forensic and non-forensic psychiatric in- and out-patients of the Forensic Department or Adult Department of the Psychiatric University Hospitals Basel with aggressive behavior problems according to their clinical treatment team (which includes senior medical doctor, therapist, nursing staff).

Exclusion Criteria:

* insufficient German language skills (in speech or reading);
* intellectual disabilities (IQ \< 70);
* epilepsy;
* acute psychotic state.

Primary outcomes:
measure: Change in Aggression Questionnaire
timeFrame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
measure: Change in Social Dysfunction and Aggression Scale (SDAS)
timeFrame: At pre-intervention (t0) and post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Secondary outcomes:
measure: Change in state-trait anger expression
timeFrame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
measure: Change in stages of change
timeFrame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
measure: Change in emotion regulation
timeFrame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
measure: Assessment of VRAPT experience
timeFrame: At post-intervention (t1= 8-16 weeks after VRAPT)
measure: Assessment of VRAPT acceptance
timeFrame: At post-intervention (t1= 8-16 weeks after VRAPT)
measure: Change in therapeutic alliance
timeFrame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Psychiatric University Hospitals (UPK) Basel
state: Basel Stadt
Study officials:
affiliation: Psychiatric University Hospitals (UPK) Basel
name: Cyril Boonmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: