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AggressionNCT06047587

Virtual Reality Training for Aggression Control

A study testing VR-TrAC and Care as Usual in people with Aggression, run by University Medical Center Groningen at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main goal of this randomized controlled trial is to investigate the effectiveness of VR-TRAC (Virtual Reality TRaining for Aggression Control) for reducing aggression in a prison-based population. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Aggression
What is being tested?
VR-TrAC and Care as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteNetherlands
Study dates
18 Apr 2023to 18 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Detainees who are imprisoned in P.I. Vught, The Netherlands, for at least 20 weeks.
  • Detainees with aggression regulation problems in the last month, as measured with the AQ (a minimum score of 70).
  • Minimum age of 18 years old.

Who cannot join

  • SCIL score of 14 or lower. (SCIL: a screener for IQ and is scored for every detainee as part of the reintegration plan inside detention).
  • Acute suicidal behavior or current psychotic episode.
  • Insufficient command and understanding of the Dutch language.
  • Photosensitive epileptic seizure in the past year.
  • An estimated stay of 5 months or shorter

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • Penitentiary Institution Vught

    Vught

    Kasja Woicik, 0611700840, k.woicik@dji.minjus.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Virtual Reality Training for Aggression Control in a Dutch Prison-based Population - a Randomized Controlled Trial

The main goal of this randomized controlled trial is to investigate the effectiveness of VR-TRAC (Virtual Reality TRaining for Aggression Control) for reducing aggression in a prison-based population. The study-design is a single-blind randomized controlled trial, comparing VR-TRAC to waiting-list control condition (WL). 128 male detainees with aggression regulation problems in the last month (measured with the Aggression Questionnaire [AQ]) and a minimum age of 18 years, recruited from the Penitentiary Institution (P.I.) Vught, the Netherlands will participate in this study. They are randomly allocated to VR-TRAC or control condition WL. The treatment group fills in questionnaires, participates in role-plays and follows the VR-TRAC. The control group filles in the same questionnaires as the treatment group and also participates in the role-plays, but does not participate in the VR-TRAC. Participants receive Care As Usual (CAU) when necessary.

To measure the effect of VR-TRAC on aggression, three different types of measurements are used: staff observation, self-report and performance-based. Self-report questionnaires will be scored on three different moments during the study: before the treatment starts, at the end of the treatment, and two- months after the treatment ended. Throughout the sessions, participants are also asked to answer questions to evaluate the sessions. Lastly, to measure the effectiveness of the skills trained in the VR-TRAC, performance-based assessments (role-play tests and vignettes) will be conducted before and after the treatment period.

Read the detailed description

In an earlier pilot study the Virtual Reality Aggression Prevention Training (VRAPT), developed by Klein Tuente, was explored and refined for a prison-based population. Changes were made and the training was adjusted to Virtual Reality Training Aggression Control (VR-TRAC). In this study the effectiveness of VR-TRAC will be explored.

The main goal of this randomized controlled trial is to investigate the effectiveness of VR-TRAC (Virtual Reality TRaining for Aggression Control) for reducing aggression in a prison-based population. The study-design is a single-blind randomized controlled trial, comparing VR-TRAC to waiting-list control condition (WL). 128 male detainees with aggression regulation problems in the last month (measured with the Aggression Questionnaire [AQ]) and a minimum age of 18 years, recruited from the Penitentiary Institution (P.I.) Vught, the Netherlands will participate in this study. They are randomly allocated to VR-TRAC or control condition WL. The treatment group fills in questionnaires, participates in role-plays and follows the VR-TRAC. The control group filles in the same questionnaires as the treatment group and also participates in the role-plays, but does not participate in the VR-TRAC. Participants receive Care As Usual (CAU) when necessary. CAU in prison consists of treatment with the main focus to stabilize a disrupted psychological state (such as pharmacological treatment, supportive contact or a transfer to a Penitentiary Psychiatric Centre where necessary interventions are applied to stabilize the disorder).

The training consists of 16 twice-weekly sessions, with a duration of 60 minutes each. The first four sessions focus on the early stages of information processing (what is happening and what does it mean). Session five through eight focus on the late information processing stages (what goals am I trying to achieve, what options do I have to react, what am I going to do, and what is the reaction or behavior). Session 10 through 15 combines the early and late stages, as all newly learned behavior will be incorporated in the interactive scenarios. To train the aforementioned stages, different aggressive-inducing situations are practiced in VR.

To measure the effect of VR-TRAC on aggression, three different types of measurements are used: staff observation, self-report and performance-based. Firstly, through staff-observation, using weekly scores of the Observation Scale for Aggressive Behaviour (OSAB) throughout the study period. Secondly, individual changes are measured through self-report measurements. The questionnaires will be scored on three different moments during the study: before the treatment starts, at the end of the treatment, and two- months after the treatment ended.

Four questionnaires will be used to measure different types of aggression, namely the Aggression Questionnaire (AQ) (which will also be used as a screening measurement), Difficulties in Emotion Regulation (DERS), the Novaco Anger Scale and Provocation Inventory (NAS-PI), and the Reactive-Proactive Questionnaire (RPQ). To measure impulsiveness the Barratt Impulsiveness Scale (BIS-11) will be used. One questionnaire, the Short Anger Measure (SAM), will be used to measure feelings of anger in the last week. It consists of 12 short items measuring feelings of anger. The questionnaire will be scored weekly and starts four weeks before the treatment starts and will end four weeks after the last treatment.

Participants are also asked to answer some questions to evaluate the session through the SRS (Session Rating Scale).

Two additional self-report questionnaires will be conducted, one on childhood trauma with the Adverse Childhood Experiences (ACE) and one on substance abuse with the Addiction for Triage \& Evaluation (MATE), Lastly, to measure the effectiveness of the skills trained in the VR-TRAC, performance-based assessments (role-play tests and vignettes) will be conducted before and after the treatment period.

Conditions
Aggression
Being tested
VR-TrAC, Care as Usual
Keywords
Virtual Reality
Medical subject headings
Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VR-TrACBehavioural

    Virtual Reality Training for Aggression. The training consists of 16 twice-weekly sessions, with a duration of 60 minutes each.

  • Care as UsualOther

    Care as usual as provided in prison.

Study groups in NCT06047587
Study groupRoleWhat they receive
VR-TrACExperimentalParticipants assigned to the VR-TrAC group will follow the training: Virtual Reality Training for Aggression. The training consists of 16 twice-weekly sessions, with a duration of 60 minutes each. The treatment protocol used in this training is based on the Virtual Reality Aggression Prevention Training (VRAPT), developed by Klein Tuente et al. (2020). The first four sessions focus on the early stages of information processing (what is happening and what does it mean). Session five through eight focus on the late information processing stages (what goals am I trying to achieve, what options do I have to react, what am I going to do, and what is the reaction or behavior). Session 10 through 15 combines the early and late stages, as all newly learned behavior will be incorporated in the interactive scenarios. To train the aforementioned stages, different aggressive-inducing situations are practiced in VR.
Receives: Behavioral: VR-TrAC
Care as UsualOtherParticipants receive Care As Usual (CAU) when necessary. CAU in prison consists of treatment with the main focus to stabilize a disrupted psychological state (such as pharmacological treatment, supportive contact or a transfer to a Penitentiary Psychiatric Centre where necessary interventions are applied to stabilize the disorder).
Receives: Other: Care as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aggression (Aggression Questionnaire, AQ)

    The primary outcome will be measured through a self-report measurement, the 'Aggression Questionnaire (AQ)', wich measures four different types of aggression. The Aggression Questionnaire (AQ) consists of 29 items measuring aggression on four different scales: physical aggression, verbal aggression, anger, and hostility. Items are filled in on a 5-point Likert scale. Higher scores indicate more aggression.

    Measured: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).

Secondary outcomes (9)
  1. Difficulties in emotion regulation (DERS)

    The Difficulties in emotion regulation (DERS) consists of 36 items measuring difficulties in emotion regulation. The DERS also provides scores on six subscales: nonacceptance of emotional responses, difficulty engaging in goal-directed behavior when distressed, impulse control difficulties when distressed, lack of awareness of emotions, limited access to strategies for regulation, and lack of emotional clarity. Items are filled in on a 5-point Likert scale. Higher scores indicate more problems with emotion regulation.

    Measured: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).

  2. Anger and Provocation (The Novaco Anger Scale and Provocation Inventory, NAS-PI)

    The Novaco Anger Scale and Provocation Inventory (NAS-PI) consists of two parts, The NAS part contains 48 questions and measures three factors; cognitive, arousal and behavior. The PI part contains 25 items that refer to anger-eliciting situations, rated on a 4-point Likert scale. Higher scores indicate more anger and issues with provocation.

    Measured: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).

  3. Reactive and proactive aggression (Reactive-Proactive Questionnaire, RPQ)

    The Reactive-Proactive Questionnaire (RPQ) consists of two 23 items (11 items on reactive aggression and 12 items on proactive aggression), rated on a 3-point Likert scale. Higher scores indicate more reactive and proactive aggression.

    Measured: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).

  4. Anger (Short Anger Measure, SAM)

    The Short Anger Measure (SAM) is a self-report and consists of 12 items measuring angry feelings and aggressive impulses over the last week, rated on a 5-point Likert scale. Higher scores indicate more aggression.

    Measured: Every week, 4 weeks before the start of the treatment and end at 4 weeks after the last treatment.

  5. Impulsiveness (Barratt Impulsiveness Scale, BIS-11)

    The Barratt Impulsiveness Scale (BIS-11) measures the personality/behavioral construct of impulsiveness. The questionnaire consists of 30 items, which provide a total score; six first-order factors: attention, motor, self-control, cognitive complexity, perseverance, cognitive instability, and three second-order factors: attentional, motor, non-planning, rated on a 4-point Likert scale. Higher scores indicate more impulsiveness.

    Measured: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).

  6. experience of VR (IGroup Presence Questionnaire, IPQ)

    The IGroup Presence Questionnaire (IPQ) will measure the experience of presence in VR. It consists of 14 items. Items are rated on a 7-point Likert scale. Higher scores indicate a better experience in VR.

    Measured: Once, after the treatment ended (posttreatment).

  7. Staff observation on aggression (Observation Scale for Aggressive Behaviour, OSAB)

    For the staff observation, the Observation Scale for Aggressive Behaviour (OSAB) will be used. The OSAB consists of 40 items measuring emotions/mood, aggressive behavior, the reason for the aggressive behavior, sanction for the patient, and socially competent behavior. Items are measured on a 4-point Likert scale. Higher scores indicate more aggressive behavior or less competent behavior.

    Measured: Every week, four weeks before the start of the treatment and end at four weeks after the last treatment ended.

  8. change in aggression measured with scripted role-plays

    To measure the effectiveness of the skills trained in the VR-TRAC, scripted role-play assessments will be conducted. Participants in the controlgroup as well in the experimental group will participate in scripted role plays. The scripted role plays consists of aggresive role-plays. Participants must react as they normally would do. The role-plays are filmed and scored. Higher scores indicate less skills or more aggressive reactions.

    Measured: Before the treatment will start and at 2 months after baseline measures (posttreatment).

  9. change in aggression measured with vignettes

    To measure the effectiveness of the skills trained in the VR-TRAC, vignettes will be conducted. Participants in the controlgroup as well in the experimental group will fill in vignettes. They consist of aggressive scenarios. Participants are asked to write down how they would react normally on the scenario.Higher scores indicate less skills or more aggressive reactions.

    Measured: Before the treatment will start and at 2 months after baseline measures (posttreatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start18 Apr 2023
  3. Primary completion18 Apr 2025 (estimated)
  4. Study completion18 Apr 2025 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047587
Sponsor's protocol ID
NL78475.042.21
Status last verified
Sep 2023
First submitted
18 Jul 2023
Last updated
21 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Klein Tuente S, Bogaerts S, Bulten E, Keulen-de Vos M, Vos M, Bokern H, IJzendoorn SV, Geraets CNW, Veling W. Virtual Reality Aggression Prevention Therapy (VRAPT) versus Waiting List Control for Forensic Psychiatric Inpatients: A Multicenter Randomized Controlled Trial. J Clin Med. 2020 Jul 16;9(7):2258. doi: 10.3390/jcm9072258.

    PubMed 32708637

Questions about this trial

What is this clinical trial studying?

A study testing VR-TrAC and Care as Usual in people with Aggression, run by University Medical Center Groningen at 1 site in Netherlands.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 Netherlands. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kasja Woicik (0653206810, k.woicik@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Aggression (Aggression Questionnaire, AQ) (time frame: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047587, which also lists 1 linked publication.

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 21 Sep 2023.

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