Treatment of aggression with Virtual Reality
| ISRCTN | ISRCTN55538093 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55538093 |
| Secondary identifying numbers | FOR-VR001 |
- Submission date
- 03/06/2020
- Registration date
- 16/11/2020
- Last edited
- 29/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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?
Märta Wallinius, marta.wallinius@kronoberg.se
Contact information
Scientific
Johan Allgulins väg 1
Växjö
352 57
Sweden
 ORCID ID |
0000-0003-0530-9560 |
|---|---|
| Phone | +46 470 589933 |
| marta.wallinius@kronoberg.se |
Scientific
Johan Allgulins väg 1
Växjö
352 57
Sweden
| Phone | +46 470 58 95 65 |
|---|---|
| fernando.gonzalezmoraga@kronoberg.se |
Study information
| Study design | Single-center, observational, case-series pilot study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Virtual Reality Aggression Prevention in Forensic Psychiatric Patients in Sweden - a pilot study |
| Study acronym | VRAPT-SF |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/02/2019 |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 18/11/2019 |
| Date of final enrolment | 31/08/2020 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Växjö
352 57
Sweden
Sponsor information
Hospital/treatment centre
Johan Allgulins väg 1
Växjö
352 57
Sweden
| Phone | +46 470586220 |
|---|---|
| ps-regpsyk@kronoberg.se | |
| Website | http://www.regionkronoberg.se/halsa-vard-tandvard/rattspsykiatri/ |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Swedish Research Council for Health, Working Life and Welfare, FORTE
- Location
- Sweden
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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 plan | 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. |
Editorial Notes
29/12/2021: The intention to publish date has been changed from 31/12/2021 to 31/12/2022.
15/12/2021: The following changes were made to the trial record:
1. The primary contact was changed.
2. The plain English summary was updated to reflect these changes.
13/10/2020: Trial’s existence confirmed by the Swedish Ethical Review Authority.
