Ignite Creation Date:
2024-05-06 @ 7:32 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06047587
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-07-18
Brief Title:
Virtual Reality Training for Aggression Control
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
Virtual Reality Training for Aggression Control in a Dutch Prison-based Population - a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PI 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
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 PI 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
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 PI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None