- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05293834
Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients
Feasibility and Pilot Study of Virtual Reality Aggression Prevention Training (VRAPT) for (Forensic) Psychiatric Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cyril Boonmann, PhD
- Phone Number: +41 61 325 82 91
- Email: cyril.boonmann@upk.ch
Study Contact Backup
- Name: Henning Hachtel, PD. Dr. med.
- Phone Number: +41 61 325 51 11
- Email: henning.hachtel@upk.ch
Study Locations
-
-
Basel Stadt
-
Basel, Basel Stadt, Switzerland, 4002
- Recruiting
- Psychiatric University Hospitals (UPK) Basel
-
Contact:
- Cyril H Boonmann, PhD
- Phone Number: +41 61 325 82 91
- Email: cyril.boonmann@upk.ch
-
Contact:
- Henning Hachtel, PD Dr. med.
- Phone Number: +41 61 325 51 11
- Email: henning.hachtel@upk.ch
-
Principal Investigator:
- Cyril Boonmann, PhD
-
Sub-Investigator:
- Madleina Manetsch, Dr. med.
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Sub-Investigator:
- Marc Graf, Prof. Dr. med.
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Sub-Investigator:
- Christian Huber, Prof. Dr.
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Sub-Investigator:
- Julian Möller, PhD
-
Sub-Investigator:
- Frieder Dechent, Dr. med.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- forensic and non-forensic psychiatric in- and out-patients of the Forensic Department or Adult Department of the Psychiatric University Hospitals Basel 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VRAPT intervention group
Data collection process:
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Aggression Questionnaire
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
To examine the effect of VRAPT on self-reported aggressive behavior in forensic and non-forensic psychiatric patients.
The Aggression Questionnaire 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."
|
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
|
Change in Social Dysfunction and Aggression Scale (SDAS)
Time Frame: At pre-intervention (t0) and post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
To examine the effect of VRAPT on observed aggressive behavior in forensic and non-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.
It 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".
|
At pre-intervention (t0) and post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in emotion regulation
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
To examine how VRAPT affects the self-reported emotion regulation in forensic and non-forensic psychiatric patients using the Difficulties in Emotion Regulation Scale.
This self-report questionnaire measures difficulties in areas such as emotional awareness, clarity, acceptance, impulse control, goal-directed behavior, and access to emotion regulation strategies.
Responses are rated on a scale, typically ranging from 1 (almost never) to 5 (almost always), to evaluate the frequency and severity of these difficulties.
|
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
|
Assessment of VRAPT acceptance
Time Frame: At post-intervention (t1= 8-16 weeks after VRAPT)
|
To examine how VRAPT is accepted, interviews are conducted with patients and therapists.
|
At post-intervention (t1= 8-16 weeks after VRAPT)
|
|
Change in therapeutic alliance
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
To examine how the therapeutic alliance with non-forensic psychiatric patients develops through the course of VRAPT, the short revised version of the Working Alliance Inventory (WAI-SR) is used.
This brief, self-report measure evaluates three key components of the quality of the therapeutic alliance between a patient and therapist: bond, task agreement, and goal agreement.
The responses are rated on a scale, typically ranging from 1 (seldom) to 7 (always), to capture the strength and effectiveness of the therapeutic relationship.
|
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
|
Change in state-trait anger expression
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
To examine how VRAPT affects the self-reported state-trait anger expression in forensic and non-forensic psychiatric patients using the State-Trait Anger Expression Inventory-2 (STAXI-2).
The STAXI-2 is a psychological assessment tool designed to examine participants' experience, expression, and control of anger.
Scores range from 0 to 80, with higher scores indicating higher levels of anger and worse emotional regulation.
|
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
|
Change in stages of change
Time Frame: At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
To examine how VRAPT affects the self-reported stages of change in forensic and non-forensic psychiatric patients using an adapted version of the University of Rhode Island Change Assessment-Domestic Violence (URICA-DV).
This tool helps helps clinicians understand an individual's motivation and readiness to alter their abusive behavior.
Scores range from 8 to 40, with higher scores indicating a greater readiness to change behavior.
|
At pre-intervention (t0), post-intervention (t1 = 8-16 weeks after VRAPT), and 12 weeks Follow-up (t2)
|
|
Assessment of VRAPT experience
Time Frame: At post-intervention (t1= 8-16 weeks after VRAPT)
|
To examine how VRAPT is experienced by patients, the I-group Presence Questionnaire (IPQ) and the Virtual Reality Sickness Questionnaire (VRSQ) are used.
The IPQ helps to determine how the sense of presence in the virtual reality environment affects the delivery and effect of VRAPT, while the VRSQ assess cybersickness.
The IPQ, with scores ranging from 0 to 80, measures individuals' beliefs and perceptions about their illness, where higher scores indicate more negative or maladaptive beliefs.
The VRSQ, with scores ranging from 0 to 120, assesses vulnerability in interpersonal relationships, with higher scores suggesting greater vulnerability and worse relational health.
|
At post-intervention (t1= 8-16 weeks after VRAPT)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Cyril Boonmann, PhD, Psychiatric University Hospitals (UPK) Basel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-02439; pk22Graf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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