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Virtual Reality Aggression Prevention Training (VRAPT) for Forensic Psychiatric Patients

Primary Purpose

Forensic Psychiatry

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Virtual Reality Aggression Prevention Training (VRAPT)
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Forensic Psychiatry focused on measuring Aggression Prevention, Virtual Reality, Virtual Reality Aggression Prevention Training (VRAPT)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • forensic psychiatric in-patients of the Forensic Department of the Psychiatric University Hospitals (UPK) Basel (UPKF) with aggressive behavior problems according to their clinical treatment team (which includes senior medical doctor, therapist, nursing staff).

Exclusion Criteria:

  • insufficient German language skills (in speech or reading);
  • intellectual disabilities (IQ < 70);
  • epilepsy;
  • acute psychotic state.

Sites / Locations

  • Psychiatric University Hospitals (UPK) BaselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VRAPT intervention group

Arm Description

Data collection process: Pre-intervention (t0): patients self-reports and staff observation; VRAPT: 8-16 weeks; Post-intervention (t1): patients self-reports, staff observations, and qualitative interview with participants and VRAPT therapists conducted by research staff; Follow-up 12 weeks after completion of the intervention (t2): patients self-reports and staff observations.

Outcomes

Primary Outcome Measures

Change in Aggression Questionnaire (AQ)
To examine the effect of VRAPT on self-reported aggressive behavior in forensic psychiatric patients. The Aggression Questionnaire (AQ) measures an individual's aggressive responses and the ability to channel those responses in a safe, constructive manner. It consists of 34 items, scored on the following scales: Physical Aggression, Verbal Aggression, Anger, Hostility, Indirect Aggression. The respondent rates each item on a 5-point scale ranging from "Not at all like me" to "Completely like me."
Change in Social Dysfunction and Aggression Scale (SDAS-9)
To examine the effect of VRAP on other-reported aggressive behavior in forensic psychiatric patients. The Social Dysfunction and Aggression Scale (SDAS) consists of 9 items (SDAS-9) covering outward aggression and 2 items (SDAS-2) covering inward aggression. The SDAS provides systematic recording of staff observations on a broad range of aggressive behaviour. Illustrative examples are: irritability, e.g., difficulty controlling reactions; negativism, e.g., not wanting to cooperate; directed verbal aggressiveness, e.g., insulting people personally. All 9 items are scored along a 4-point scale ranging from absent to severely present.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2022
Last Updated
May 4, 2023
Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Psychiatric Clinics Basel
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1. Study Identification

Unique Protocol Identification Number
NCT05293834
Brief Title
Virtual Reality Aggression Prevention Training (VRAPT) for Forensic Psychiatric Patients
Official Title
Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for Forensic Psychiatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
University Psychiatric Clinics Basel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Violent and aggressive behavior as well as disorders related to aggressive behavior are highly common in both adult and juvenile forensic psychiatric patients.One promising new treatment option is Virtual Reality (VR). A newly developed program in this area is the Virtual Reality Aggression Prevention Training (VRAPT). The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss forensic psychiatric setting, including both adult and juvenile patients, and to examine whether VRAPT is an effective treatment method for aggressive behavior in forensic psychiatric settings.
Detailed Description
Violent and aggressive behavior as well as disorders related to aggressive behavior are highly common in both adult and juvenile forensic psychiatric patients. In order to minimize the risk for future violent offending it is important to intervene in this high risk population. Previous research showed that punishment alone is counterproductive for repeated offending behavior. In contrast, treatment was found to have a positive effect on reoffending (i.e., less reoffending). However, although knowledge about the treatment of forensic psychiatric patients has increased significantly in recent decades, it is still not fully understood what works for whom under what circumstances. One promising new treatment option is Virtual Reality (VR). A newly developed program in this area is the Virtual Reality Aggression Prevention Training (VRAPT). This training is currently implemented and examined in correctional and forensic psychiatric facilities in the Netherlands and in Sweden. Results from the first randomized controlled trial (RCT) of the effectiveness of the intervention showed that the VRAPT group showed a decrease in some aggressive behaviors at post-test, but not anymore at 3-month follow-up. The purpose of the current feasibility and pilot study is to test VRAPT in a Swiss forensic psychiatric setting, including both adult and juvenile patients, and to gather information needed for the design of a large, international, high-quality, multicenter RCT. The research questions will address the effect of VRAPT on aggressive behavior, state-trait anger expression, stages of motivational change, and emotion regulation. The present investigation will be the first study to include juvenile forensic psychiatric patients as well as to test VRAPT in Switzerland, thereby increasing the generalizability of the research to other populations. In addition, it will address problem awareness and therapy motivation as possible factors influencing treatment outcome, and address some of the limitations of previous research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Forensic Psychiatry
Keywords
Aggression Prevention, Virtual Reality, Virtual Reality Aggression Prevention Training (VRAPT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
VRAPT intervention group
Arm Type
Experimental
Arm Description
Data collection process: Pre-intervention (t0): patients self-reports and staff observation; VRAPT: 8-16 weeks; Post-intervention (t1): patients self-reports, staff observations, and qualitative interview with participants and VRAPT therapists conducted by research staff; Follow-up 12 weeks after completion of the intervention (t2): patients self-reports and staff observations.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Aggression Prevention Training (VRAPT)
Intervention Description
VRAPT consists of sixteen 45- to 60-minute sessions that take place once or twice per week (total duration of the intervention = 8 to 16 weeks). Session time and intensity will be adapted to the individual participant and the sessions will be delivered by specially trained VRAPT therapists in individual settings. The immersive and interactive three-dimensional virtual environment will be presented via headphones and head-mounted displays, using software developed by CleVR. In the virtual environment, participants will interact with virtual characters that are controlled by the psychotherapist and practice new skills . The therapy program is targeted at factors and processes related to aggression and the underlying theoretical framework is based on cognitive behavioural therapy and the General Aggression Model (GAM). The VRAPT consists of 4 phases: Introduction (Session 1) Inventory phase (Sessions 2-6) Skills-training (Sessions 6-15) Evaluation (Session 16)
Primary Outcome Measure Information:
Title
Change in Aggression Questionnaire (AQ)
Description
To examine the effect of VRAPT on self-reported aggressive behavior in forensic psychiatric patients. The Aggression Questionnaire (AQ) measures an individual's aggressive responses and the ability to channel those responses in a safe, constructive manner. It consists of 34 items, scored on the following scales: Physical Aggression, Verbal Aggression, Anger, Hostility, Indirect Aggression. The respondent rates each item on a 5-point scale ranging from "Not at all like me" to "Completely like me."
Time Frame
At VRAPT- Post-intervention (t1 = 8 -16 weeeks after VRAPT- intervention ) and 12 weeks Follow-up (t2); up to 12 weeks
Title
Change in Social Dysfunction and Aggression Scale (SDAS-9)
Description
To examine the effect of VRAP on other-reported aggressive behavior in forensic psychiatric patients. The Social Dysfunction and Aggression Scale (SDAS) consists of 9 items (SDAS-9) covering outward aggression and 2 items (SDAS-2) covering inward aggression. The SDAS provides systematic recording of staff observations on a broad range of aggressive behaviour. Illustrative examples are: irritability, e.g., difficulty controlling reactions; negativism, e.g., not wanting to cooperate; directed verbal aggressiveness, e.g., insulting people personally. All 9 items are scored along a 4-point scale ranging from absent to severely present.
Time Frame
At VRAPT- Post-intervention (t1 = 8 -16 weeeks after VRAPT- intervention ) and 12 weeks Follow-up (t2); up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: forensic psychiatric in-patients of the Forensic Department of the Psychiatric University Hospitals (UPK) Basel (UPKF) with aggressive behavior problems according to their clinical treatment team (which includes senior medical doctor, therapist, nursing staff). Exclusion Criteria: insufficient German language skills (in speech or reading); intellectual disabilities (IQ < 70); epilepsy; acute psychotic state.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyril Boonmann, PhD
Phone
+41 61 325 82 91
Email
cyril.boonmann@upk.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Henning Hachtel, PD. Dr. med.
Phone
+41 61 325 51 11
Email
henning.hachtel@upk.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cyril Boonmann, PhD
Organizational Affiliation
Psychiatric University Hospitals (UPK) Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric University Hospitals (UPK) Basel
City
Basel
State/Province
Basel Stadt
ZIP/Postal Code
4002
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril H Boonmann, PhD
Phone
+41 61 325 82 91
Email
cyril.boonmann@upk.ch
First Name & Middle Initial & Last Name & Degree
Henning Hachtel, PD Dr. med.
Phone
+41 61 325 51 11
Email
henning.hachtel@upk.ch
First Name & Middle Initial & Last Name & Degree
Cyril Boonmann, PhD
First Name & Middle Initial & Last Name & Degree
Madleina Manetsch, Dr. med.
First Name & Middle Initial & Last Name & Degree
Marc Graf, Prof. Dr. med.

12. IPD Sharing Statement

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Virtual Reality Aggression Prevention Training (VRAPT) for Forensic Psychiatric Patients

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