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

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

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.

Study 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.

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Basel Stadt
      • Basel, Basel Stadt, Switzerland, 4002
        • Recruiting
        • Psychiatric University Hospitals (UPK) Basel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cyril Boonmann, PhD
        • Sub-Investigator:
          • Madleina Manetsch, Dr. med.
        • Sub-Investigator:
          • Marc Graf, Prof. Dr. med.
        • Sub-Investigator:
          • Christian Huber, Prof. Dr.
        • Sub-Investigator:
          • Julian Möller, PhD
        • Sub-Investigator:
          • Frieder Dechent, Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VRAPT intervention group

Data collection process:

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

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:

  1. Introduction (Session 1)
  2. Inventory phase (Sessions 2-6)
  3. Skills-training (Sessions 6-15)
  4. Evaluation (Session 16)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Aggression Questionnaire
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
To examine the effect of VRAPT on self-reported aggressive behavior in forensic and non-forensic psychiatric patients. The Aggression Questionnaire 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."
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)
To examine the effect of VRAPT on observed aggressive behavior in forensic and non-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. It 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".
At pre-intervention (t0) and post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in emotion regulation
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
To examine how VRAPT affects the self-reported emotion regulation in forensic and non-forensic psychiatric patients using the Difficulties in Emotion Regulation Scale. This self-report questionnaire measures difficulties in areas such as emotional awareness, clarity, acceptance, impulse control, goal-directed behavior, and access to emotion regulation strategies. Responses are rated on a scale, typically ranging from 1 (almost never) to 5 (almost always), to evaluate the frequency and severity of these difficulties.
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Assessment of VRAPT acceptance
Time Frame: At post-intervention (t1= 8-16 weeks after VRAPT)
To examine how VRAPT is accepted, interviews are conducted with patients and therapists.
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)
To examine how the therapeutic alliance with non-forensic psychiatric patients develops through the course of VRAPT, the short revised version of the Working Alliance Inventory (WAI-SR) is used. This brief, self-report measure evaluates three key components of the quality of the therapeutic alliance between a patient and therapist: bond, task agreement, and goal agreement. The responses are rated on a scale, typically ranging from 1 (seldom) to 7 (always), to capture the strength and effectiveness of the therapeutic relationship.
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
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)
To examine how VRAPT affects the self-reported state-trait anger expression in forensic and non-forensic psychiatric patients using the State-Trait Anger Expression Inventory-2 (STAXI-2). The STAXI-2 is a psychological assessment tool designed to examine participants' experience, expression, and control of anger. Scores range from 0 to 80, with higher scores indicating higher levels of anger and worse emotional regulation.
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)
To examine how VRAPT affects the self-reported stages of change in forensic and non-forensic psychiatric patients using an adapted version of the University of Rhode Island Change Assessment-Domestic Violence (URICA-DV). This tool helps helps clinicians understand an individual's motivation and readiness to alter their abusive behavior. Scores range from 8 to 40, with higher scores indicating a greater readiness to change behavior.
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)
To examine how VRAPT is experienced by patients, the I-group Presence Questionnaire (IPQ) and the Virtual Reality Sickness Questionnaire (VRSQ) are used. The IPQ helps to determine how the sense of presence in the virtual reality environment affects the delivery and effect of VRAPT, while the VRSQ assess cybersickness. The IPQ, with scores ranging from 0 to 80, measures individuals' beliefs and perceptions about their illness, where higher scores indicate more negative or maladaptive beliefs. The VRSQ, with scores ranging from 0 to 120, assesses vulnerability in interpersonal relationships, with higher scores suggesting greater vulnerability and worse relational health.
At post-intervention (t1= 8-16 weeks after VRAPT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2022

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

March 14, 2022

First Posted (Actual)

March 24, 2022

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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