Condition category
Mental and Behavioural Disorders
Date applied
03/06/2020
Date assigned
16/11/2020
Last edited
16/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The evidence base for forensic psychiatric care is severely lacking, and there are no available treatment methods that have been established as effective in Swedish forensic psychiatry. Lately, new treatment methods using Virtual Reality (VR) have been developed for various mental disorders. Using Virtual Reality as a tool in the treatment could provide possibilities for forensic psychiatry to assist patients with skills training in contexts that are relevant to the “regular” life, and not just life as an inpatient in forensic psychiatry.

In this study, a newly developed method for VR-assisted treatment of aggression (the VRAPT), specifically designed for forensic psychiatry, will be translated (from Dutch) to Swedish and tested in a small study on forensic psychiatric inpatients to see how effective it is in treating aggression.

Who can participate?
Adult inpatients sentenced to forensic psychiatric care for treatment at a maximum security forensic psychiatric hospital in Sweden with a history of aggression and/or current problems with aggression.

What does the study involve?
During participation, participants will undergo the 16-session individual VRAPT treatment delivered by specially trained VR therapists. Data is collected on a total of 4 occasions: 1) 12 weeks before the start of treatment, 2) at the start of treatment, 3) at end of treatment and 4) 12 weeks after the end of treatment. Data will be collected on 1) current and past aggression, violence, and criminality, 2) sociodemographic data and psychosocial background, 3) mental health history and current status including emotion regulation, 4) sense of presence in the virtual environment, and 5) patients' and therapists' experiences of the VRAPT.

What are the possible benefits and risks of participating?
The participation in the study is in no way related to the treatment of the patients, why no direct benefits related to their forensic psychiatric treatment are available. All participating patients will receive a minor reimbursement (of approximately 12 euro) after completed participation.

Possible risks are handled through only including patients who have been assessed as capable of providing informed consent. All participation is conducted under strict, clinical safety routines with observation and support available for all participants.

Where is the study run from?
Regional Forensic Psychiatric Clinic (Sweden)

When is the study starting and how long is it expected to run for?
From February 2019 to December 2020

Who is funding the study?
Southern Healthcare Region, Region Kronoberg, and The Research Council for Health, Work Life and Welfare (Sweden)

Who is the main contact?
Miss Stéphanie Klein Tuente
stephana.kleintuente@kronoberg.se

Trial website

https://celam.gu.se/forevidence/for-vr/?languageId=100001&disableRedirect=true&returnUrl=http%3A%2F%2Fcelam.gu.se%2Fsvenska%2Fforevidence%2Ffor-vr%2F

Contact information

Type

Scientific

Primary contact

Miss Stéphanie Klein Tuente

ORCID ID

Contact details

Johan Allgulins väg 1
Växjö
352 57
Sweden
+46 70 967 3403
stephana.kleintuente@kronoberg.se

Type

Scientific

Additional contact

Dr Märta Wallinius

ORCID ID

http://orcid.org/0000-0003-0530-9560

Contact details

Johan Allgulins väg 1
Växjö
352 57
Sweden
+46 470 58 99 33
marta.wallinius@med.lu.se

Type

Scientific

Additional contact

Mr Fernando Gonzalez Moraga

ORCID ID

Contact details

Johan Allgulins väg 1
Växjö
352 57
Sweden
+46 470 58 95 65
fernando.gonzalezmoraga@kronoberg.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

FOR-VR001

Study information

Scientific title

Virtual Reality Aggression Prevention in Forensic Psychiatric Patients in Sweden - a pilot study

Acronym

VRAPT-SF

Study hypothesis

This pilot study aims to test the feasibility and applicability of Virtual Reality Aggression Prevention Training (VRAPT) in a sample of Swedish forensic psychiatric inpatients, with the following, primary aim:
1. To investigate the effect of VRAPT on the occurrence and severity of aggressive behaviours in forensic psychiatric patients.

Secondary research questions are:
1. How does VRAPT affect emotion regulation in forensic psychiatric patients?
2. Which important confounders (e.g., sense of presence in the virtual environment, psychosocial background and mental health characteristics including personality of the patients, presence of other externalizing behaviours including substance use) need to be considered in evaluation of treatment effect of VRAPT?
3. How is VRAPT experienced by participating patients and staff?

Ethics approval

Approved 06/05/2019, the Swedish Ethical Review Authority (Etikprövningsmyndigheten Box 2110, 750 02 Uppsala, Sweden; registrator@etikprovning.se; + 46 (0)10 475 08 00), ref: 2019-02337.

Study design

Single-center, observational, case-series pilot study

Primary study design

Observational

Secondary study design

Case series

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Forensic psychiatric inpatients with aggression regulation problems

Intervention

The Virtual Reality Aggression Prevention Training (VRAPT) consists of 16 individual treatment sessions, delivered by specially trained VRAPT therapists using the VRAPT treatment manual and workbooks together with Virtual Reality technology. Before, during, and after VRAPT treatment, participants are followed with staff observations, self-reports, and medical file reviews. After completed participation, individual interviews with patients and therapists on their experiences from the VRAPT will be performed.

Each session is delivered according to the VRAPT-manual, with the first 6 sessions being devoted to mapping aggression problems, formulating treatment goals, practicing emotion recognition, and practicing recognition and management of physical tension. During sessions 6-15, the treatment focuses on practicing de-escalation strategies and aggression management. The final session considers the treatment evaluation. The sessions are provided 1-2 times a week.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Occurrence and severity of aggressive behaviours demonstrated by forensic psychiatric patients, assessed through staff reports using The Social Dysfunction and Aggression Scale-9, self-reports (Aggression Questionnaire-Revised Swedish Version; State-Trait Anger eXpression Inventory-2), and collected from medical files. Staff reports and information from medical files will be collected continuously from baseline (12 weeks prior to treatment start), through the treatment, and 12 weeks after completed treatment. Self-reports will be conducted directly before treatment start, directly after completed treatment, and 12 weeks after completed treatment.

Secondary outcome measures

1. Self-reported emotion regulation (Difficulties in Emotion Regulation Scale) will be collected from patients directly before treatment start, directly after completed treatment, and 12 weeks after completed treatment
2. Treatment fidelity will be assessed through the therapist's workbook, where the therapist assesses fidelity for each session directly after the session, which will be collected continuously during treatment in the VRAPT treatment protocol
3. Importance of confounders will be investigated through collecting information on psychosocial background including childhood adversities (self-report with Childhood Trauma Questionnaire- Short Form; medical files), mental health characteristics and history (medical files), and history of externalizing behaviours and callous aggression (Externalizing Spectrum Inventory-Brief Form; medical files) which will be collected directly before the treatment start
4. Sense of presence in the virtual environment will be assessed through self-report (I-group Presence Questionnaire) directly after completed treatment
5. Experiences from the VRAPT treatment will be assessed through interviews with therapists and participating patients conducted after completed participation

Overall trial start date

01/02/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Sentenced to forensic psychiatric care and are being treated as inpatients at a maximum security forensic psychiatric hospital in Sweden
2. History of aggression and/or current problems with reactive aggression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant exclusion criteria

1. Inability to understand the meaning of participating in the study, and insufficient psychiatric status to provide informed consent
2. Insufficient skills in the Swedish language that impede active participation in all parts of the study
3. Epilepsy
4. Intellectual disabilities (IQ <70)
5. Autism spectrum disorder with severely impaired functioning
6. Acute psychotic state
7. Current and serious security risks that prevent safe participation

Recruitment start date

18/11/2019

Recruitment end date

31/08/2020

Locations

Countries of recruitment

Sweden

Trial participating centre

Regional Forensic Psychiatric Clinic
Johan Allgulins väg 1
Växjö
352 57
Sweden

Sponsor information

Organisation

Regional Forensic Psychiatric Clinic

Sponsor details

Johan Allgulins väg 1
Växjö
352 57
Sweden
+46 470586220
ps-regpsyk@kronoberg.se

Sponsor type

Hospital/treatment centre

Website

http://www.regionkronoberg.se/halsa-vard-tandvard/rattspsykiatri/

Funders

Funder type

Government

Funder name

Forskningsrådet om Hälsa, Arbetsliv och Välfärd

Alternative name(s)

Swedish Research Council for Health, Working Life and Welfare, FORTE

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

Sweden

Funder name

Region Kronoberg, Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Southern Healthcare Region, Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results at the group level will be made public in international, scientific journals, through debate articles in trade journals or established media, and presented to user organizations, family associations, patients in forensic psychiatric care, and adjacent health organizations and authorities through an established dissemination plan at the responsible research department. Preliminary results are expected to be presented early 2021, with scientific publications during 2021-2022.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from principal investigator, Märta Wallinius, marta.wallinius@med.lu.se. Data will be available after data preparation have been finished, and only available for group level analyses, in accordance with ethical approval. All data will be anonymized, and data that may risk identification will be deleted before sharing.

Intention to publish date

31/12/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/10/2020: Trial’s existence confirmed by the Swedish Ethical Review Authority.