search
Back to results

Virtual Reality Training for Aggression Control

Primary Purpose

Aggression

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
VR-TrAC
Care as Usual
Sponsored by
University Medical Center Groningen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggression focused on measuring Virtual Reality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Penitentiary Institution VughtRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

VR-TrAC

Care as Usual

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
July 18, 2023
Last Updated
September 14, 2023
Sponsor
University Medical Center Groningen
search

1. Study Identification

Unique Protocol Identification Number
NCT06047587
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2023 (Actual)
Primary Completion Date
April 18, 2025 (Anticipated)
Study Completion Date
April 18, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medical Center Groningen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggression
Keywords
Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VR-TrAC
Arm Type
Experimental
Arm Description
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.
Arm Title
Care as Usual
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
VR-TrAC
Intervention Description
Virtual Reality Training for Aggression. The training consists of 16 twice-weekly sessions, with a duration of 60 minutes each.
Intervention Type
Other
Intervention Name(s)
Care as Usual
Intervention Description
Care as usual as provided in prison.
Primary Outcome Measure Information:
Title
Aggression (Aggression Questionnaire, AQ)
Description
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.
Time Frame
Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
Secondary Outcome Measure Information:
Title
Difficulties in emotion regulation (DERS)
Description
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.
Time Frame
Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
Title
Anger and Provocation (The Novaco Anger Scale and Provocation Inventory, NAS-PI)
Description
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.
Time Frame
Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
Title
Reactive and proactive aggression (Reactive-Proactive Questionnaire, RPQ)
Description
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.
Time Frame
Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
Title
Anger (Short Anger Measure, SAM)
Description
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.
Time Frame
Every week, 4 weeks before the start of the treatment and end at 4 weeks after the last treatment.
Title
Impulsiveness (Barratt Impulsiveness Scale, BIS-11)
Description
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.
Time Frame
Before the treatment, 2 months after baseline (posttreatment), and 2 months after the treatment ended (follow-up).
Title
experience of VR (IGroup Presence Questionnaire, IPQ)
Description
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.
Time Frame
Once, after the treatment ended (posttreatment).
Title
Staff observation on aggression (Observation Scale for Aggressive Behaviour, OSAB)
Description
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.
Time Frame
Every week, four weeks before the start of the treatment and end at four weeks after the last treatment ended.
Title
change in aggression measured with scripted role-plays
Description
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.
Time Frame
Before the treatment will start and at 2 months after baseline measures (posttreatment).
Title
change in aggression measured with vignettes
Description
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.
Time Frame
Before the treatment will start and at 2 months after baseline measures (posttreatment).

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kasja Woicik
Phone
0653206810
Email
k.woicik@umcg.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Geraets
Phone
+31(0)50-3614367
Email
c.n.w.geraets@umcg.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wim Veling
Organizational Affiliation
University of Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penitentiary Institution Vught
City
Vught
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasja Woicik
Phone
0611700840
Email
k.woicik@dji.minjus.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32708637
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.
Results Reference
background

Learn more about this trial

Virtual Reality Training for Aggression Control

We'll reach out to this number within 24 hrs