Recruiting NCT05293834

Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients

No phase Interventional Forensic Psychiatry

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Virtual Reality Aggression Prevention Training (VRAPT).
Who it may be relevant to: Registry conditions: Forensic Psychiatry. Basic parameters: from 12 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Switzerland
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients

Overview

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.

Interventions

Behavioral Virtual Reality Aggression Prevention Training (VRAPT)
VRAPT consists of sixteen 45- to 60-minute sessions that take place once or twice per week (total duration of the intervention = 8 to 16 weeks). Session time and intensity will be adapted to the individual participant and the sessions will be delivered by specially trained VRAPT therapists in individual settings. The immersive and interactive three-dimensional virtual environment will be presented via headphones and head-mounted displays, using software developed by CleVR. In the virtual environ

Primary outcome measures

Change in Aggression Questionnaire [Time frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
Change in Social Dysfunction and Aggression Scale (SDAS) [Time frame: At pre-intervention (t0) and post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]

Secondary outcome measures (6)

Change in state-trait anger expression [Time frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
Change in stages of change [Time frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
Change in emotion regulation [Time frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]
Assessment of VRAPT experience [Time frame: At post-intervention (t1= 8-16 weeks after VRAPT)]
Assessment of VRAPT acceptance [Time frame: At post-intervention (t1= 8-16 weeks after VRAPT)]
Change in therapeutic alliance [Time frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Switzerland · 1 center

Psychiatric University Hospitals (UPK) Basel — Basel

Identifiers

NCT: NCT05293834 · 2021-02439; pk22Graf

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗