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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05293834
Collaborator
University Psychiatric Clinics Basel (Other)
34
1
1
20
1.7

Study Details

Study Description

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.One promising new treatment option is Virtual Reality (VR). 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 psychiatric setting, including both adult and juvenile patients, and to examine whether VRAPT is an effective treatment method for aggressive behavior in forensic psychiatric settings.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual Reality Aggression Prevention Training (VRAPT)
N/A

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. In order to minimize the risk for future violent offending it is important to intervene in this high risk population. 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 what circumstances. One promising new treatment option is Virtual Reality (VR). 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 of the first Randomized Controlled Trial (RCT) on the effectiveness of the intervention showed that the VRAPT group showed a decrease in aggressive behavior at post-test and 3-months follow-up. The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss 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, and emotion regulation. 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. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for Forensic Psychiatric Patients
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: VRAPT intervention group

Data collection process: Pre-intervention (t0): patients self-reports and staff observation; VRAPT: 8-16 weeks; Post-intervention (t1): patients self-reports, staff observations, and qualitative interview with participants and VRAPT therapists conducted by research staff; Follow-up 12 weeks after completion of the intervention (t2): patients self-reports and staff observations.

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 environment, participants will interact with virtual characters that are controlled by the psychotherapist and practice new skills . The therapy program is targeted at factors and processes related to aggression and the underlying theoretical framework is based on cognitive behavioural therapy and the General Aggression Model (GAM). The VRAPT consists of 4 phases: Introduction (Session 1) Inventory phase (Sessions 2-6) Skills-training (Sessions 6-15) Evaluation (Session 16)

Outcome Measures

Primary Outcome Measures

  1. Change in Aggression Questionnaire (AQ) [At VRAPT- Post-intervention (t1 = 8 -16 weeeks after VRAPT- intervention ) and 12 weeks Follow-up (t2); up to 12 weeks]

    To examine the effect of VRAPT on self-reported aggressive behavior in forensic psychiatric patients. The Aggression Questionnaire (AQ) measures an individual's aggressive responses and the ability to channel those responses in a safe, constructive manner. It consists of 34 items, scored on the following scales: Physical Aggression, Verbal Aggression, Anger, Hostility, Indirect Aggression. The respondent rates each item on a 5-point scale ranging from "Not at all like me" to "Completely like me."

  2. Change in Social Dysfunction and Aggression Scale (SDAS-9) [At VRAPT- Post-intervention (t1 = 8 -16 weeeks after VRAPT- intervention ) and 12 weeks Follow-up (t2); up to 12 weeks]

    To examine the effect of VRAP on other-reported aggressive behavior in forensic psychiatric patients. The Social Dysfunction and Aggression Scale (SDAS) consists of 9 items (SDAS-9) covering outward aggression and 2 items (SDAS-2) covering inward aggression. The SDAS provides systematic recording of staff observations on a broad range of aggressive behaviour. Illustrative examples are: irritability, e.g., difficulty controlling reactions; negativism, e.g., not wanting to cooperate; directed verbal aggressiveness, e.g., insulting people personally. All 9 items are scored along a 4-point scale ranging from absent to severely present.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • forensic psychiatric in-patients of the Forensic Department of the Psychiatric University Hospitals (UPK) Basel (UPKF) 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Psychiatric University Hospitals (UPK) Basel Basel Basel Stadt Switzerland 4002

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland
  • University Psychiatric Clinics Basel

Investigators

  • Principal Investigator: Cyril Boonmann, PhD, Psychiatric University Hospitals (UPK) Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05293834
Other Study ID Numbers:
  • 2021-02439; pk22Graf
First Posted:
Mar 24, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022