Clinical trial NCT06047587: Virtual Reality Training for Aggression Control
Official title: Virtual Reality Training for Aggression Control in a Dutch Prison-based Population - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aggression
Keywords: Virtual Reality
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 128
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Aggression (Aggression Questionnaire, AQ)
timeFrame: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
Secondary outcomes:
measure: Difficulties in emotion regulation (DERS)
timeFrame: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
measure: Anger and Provocation (The Novaco Anger Scale and Provocation Inventory, NAS-PI)
timeFrame: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
measure: Reactive and proactive aggression (Reactive-Proactive Questionnaire, RPQ)
timeFrame: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
measure: Anger (Short Anger Measure, SAM)
timeFrame: Every week, 4 weeks before the start of the treatment and end at 4 weeks after the last treatment.
measure: Impulsiveness (Barratt Impulsiveness Scale, BIS-11)
timeFrame: Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
measure: experience of VR (IGroup Presence Questionnaire, IPQ)
timeFrame: Once, after the treatment ended (posttreatment).
measure: Staff observation on aggression (Observation Scale for Aggressive Behaviour, OSAB)
timeFrame: Every week, four weeks before the start of the treatment and end at four weeks after the last treatment ended.
measure: change in aggression measured with scripted role-plays
timeFrame: Before the treatment will start and at 2 months after baseline measures (posttreatment).
measure: change in aggression measured with vignettes
timeFrame: Before the treatment will start and at 2 months after baseline measures (posttreatment).
Other outcomes:
Locations:
city: Vught
country: Netherlands
facility: Penitentiary Institution Vught
Study officials:
affiliation: University of Groningen
name: Wim Veling
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.