Forensic PsychiatryNCT05293834
Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients
A study testing Virtual Reality Aggression Prevention Training (VRAPT) in people with Forensic Psychiatry, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Forensic Psychiatry
- What is being tested?
- Virtual Reality Aggression Prevention Training (VRAPT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Sep 2022to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- insufficient German language skills (in speech or reading);
- intellectual disabilities (IQ < 70);
- epilepsy;
- acute psychotic state.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Psychiatric University Hospitals (UPK) Basel
Basel, Canton of Basel-City, 4002
Cyril H Boonmann, PhD, +41 61 325 82 91, cyril.boonmann@upk.ch
Henning Hachtel, PD Dr. med., +41 61 325 51 11, henning.hachtel@upk.ch
About this study
Official title: 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.
Read the 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.
- Conditions
- Forensic Psychiatry
- Being tested
- Virtual Reality Aggression Prevention Training (VRAPT)
- Keywords
- Aggression Prevention, Virtual Reality, Virtual Reality Aggression Prevention Training (VRAPT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Aggression Prevention Training (VRAPT)Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual Reality Aggression Prevention Training (VRAPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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".
Measured: 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
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.
Measured: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Change in stages of change
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.
Measured: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Change in emotion regulation
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.
Measured: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Assessment of VRAPT experience
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.
Measured: At post-intervention (t1= 8-16 weeks after VRAPT)
Assessment of VRAPT acceptance
To examine how VRAPT is accepted, interviews are conducted with patients and therapists.
Measured: At post-intervention (t1= 8-16 weeks after VRAPT)
Change in therapeutic alliance
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.
Measured: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2022
- Study start21 Sep 2022
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forensic PsychiatryStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University Psychiatric Clinics Basel
- Responsible party
- Sponsor
- Investigators
- Cyril Boonmann, PhD, Principal investigator, Psychiatric University Hospitals (UPK) Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293834
- Sponsor's protocol ID
- 2021-02439; pk22Graf
- Status last verified
- Jul 2025
- First submitted
- 24 Jan 2022
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients
- ClinicalTrials.gov ID
- NCT05293834
- Acronym / sponsor ID
- 2021-02439; pk22Graf
- Conditions
- Forensic Psychiatry
- Keywords
- Aggression Prevention, Virtual Reality, Virtual Reality Aggression Prevention Training (VRAPT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University Psychiatric Clinics Basel
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VRAPT intervention group | Experimental | Behavioral: Virtual Reality Aggression Prevention Training (VRAPT)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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (4 listed)
- insufficient German language skills (in speech or reading);
- intellectual disabilities (IQ < 70);
- epilepsy;
- acute psychotic state.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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: 1. Introduction (Session 1) 2. Inventory phase (Sessions 2-6) 3. Skills-training (Sessions 6-15) 4. Evaluation (Session 16) | Behavioural | VRAPT intervention group |
Primary outcome
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."
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".
6 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cyril Boonmann, PhD principal investigator
Psychiatric University Hospitals (UPK) Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Aggression Prevention Training (VRAPT) in people with Forensic Psychiatry, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cyril Boonmann, PhD (+41 61 325 82 91, cyril.boonmann@upk.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aggression Questionnaire (time frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.