NCT06047587

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

July 18, 2023

Last Update Submit

September 14, 2023

Conditions

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (9)

  • Difficulties in emotion regulation (DERS)

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

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

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

  • Reactive and proactive aggression (Reactive-Proactive Questionnaire, RPQ)

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

  • Anger (Short Anger Measure, SAM)

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

  • Impulsiveness (Barratt Impulsiveness Scale, BIS-11)

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

  • +4 more secondary outcomes

Study Arms (2)

VR-TrAC

EXPERIMENTAL

Participants 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.

Behavioral: VR-TrAC

Care as Usual

OTHER

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).

Other: Care as Usual

Interventions

VR-TrACBEHAVIORAL

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

VR-TrAC

Care as usual as provided in prison.

Care as Usual

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penitentiary Institution Vught

Vught, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32708637BACKGROUND

MeSH Terms

Conditions

Aggression

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Wim Veling

    University of Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

September 21, 2023

Study Start

April 18, 2023

Primary Completion

April 18, 2025

Study Completion

April 18, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations