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

NCT05293834 | Recruiting

• 1 other identifier: 2021-02439; pk22Graf
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Forensic Psychiatry

Keywords

Aggression Prevention; Virtual Reality; Virtual Reality Aggression Prevention Training (VRAPT)

Outcome Measures

Primary Outcomes (2)

• Change in Aggression Questionnaire

  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)

  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 Outcomes (6)

• Change in state-trait anger expression

  At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)

• Change in stages of change

  At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)

• Change in emotion regulation

  At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)

• Assessment of VRAPT experience

  At post-intervention (t1= 8-16 weeks after VRAPT)

• Assessment of VRAPT acceptance

  At post-intervention (t1= 8-16 weeks after VRAPT)

Study Arms (1)

VRAPT intervention group

EXPERIMENTAL

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.

Behavioral: Virtual Reality Aggression Prevention Training (VRAPT)

Interventions

Virtual Reality Aggression Prevention Training (VRAPT) BEHAVIORAL

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)

VRAPT intervention group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University Psychiatric Clinics Basel: collaborator

Study Sites (1)

Psychiatric University Hospitals (UPK) Basel

Basel, Canton of Basel-City, 4002, Switzerland

RECRUITING

Study Officials

• Cyril Boonmann, PhD

  Psychiatric University Hospitals (UPK) Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyril Boonmann, PhD

CONTACT

+41 61 325 82 91; cyril.boonmann@upk.ch

Henning Hachtel, PD. Dr. med.

CONTACT

+41 61 325 51 11; henning.hachtel@upk.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 24, 2022
• Study Start: September 21, 2022
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

CH (1)