Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Approximately 45% of all Dutch people experience one form of domestic violence (DV) during their lifetime. Domestic violence can be defined as 'any incident of threatening behavior, violence or abuse (psychological, physical, sexual, financial or emotional) between adults who are or have been an intimate partner, family member, friend or otherwise closely involved. Recent studies have found a high prevalence of domestic violence among female and male psychiatric patients. Results from the Dutch nationwide study on victimization in psychiatric patients suggest a 6 fold increase of domestic violence in severe mental illness patients as compared to the general population. Domestic violence can result in anxiety, depression, post-traumatic stress disorder, addiction and psychosis. However, domestic violence in psychiatric patients is often not detected. Only around 10-30% of cases are detected by psychiatric service providers. Research has shown that identification of victims of domestic violence by health care professionals can increase with training and organizational change within health care systems. The aim of this study is to train and educate professionals in health care on domestic violence and strengthen referral pathways to and from specialized services in domestic violence. By doing this, the aim is to improve detection and referral rates of domestic violence and eventually reduce victimization of psychiatric patients.

Who can participate?
The study includes CMH service teams: FACT teams (Functional Assertive Community Treatment) which are teams specialized in outreaching health care. All FACT-teams operating in Rotterdam and around are eligible for inclusion. The FACT teams all have about 200-250 patients with severe mental illness in their care. One FACT team consists of a psychiatrist, psychologist, social psychiatric nurses and social workers.

What does the study involve?
The BRAVE intervention (or programme) is made up of 8-hours of training for 12 FACT teams on domestic violence, a 6 hour training of DV professionals at GGD Rijnmond about psychiatric patients, and a pathways for referrals back and forth between FACT teams and DV professionals at GGD Rijnmond (municipal services specializing in specializing in domestic violence). FACT teams are randomly allocated into 12 intervention and 12 control teams. The control teams give care as usual. The referral rates and detection rates of cases of domestic violence are assessed over the period of one year from the start of the intervention. At the end of the study, the number of detected cases of domestic violence and the number of referrals to the services for domestic violence are compared. To evaluate the feasibility, sustainability and acceptance of the intervention, a sample of members of the FACT teams from the intervention group and the control group as well as some people from the teams working at GGD Rijnmond are interviewed.

What are the possible risks and benefits of participating?
It is hoped that by an increase of detection of domestic violence, patients will be referred to the GGD Rijnmond teams faster and that they’ll receive fitting care regarding domestic violence. It is also hoped that, in time, the risk of domestic violence against psychiatric patients will decrease and that the burden for psychiatric patients being victimized by domestic violence will decrease. Adverse events will be reported.

Where is the study run from?
The study is run from the Erasmus Medical Center, Department of Psychiatry. The study is conducted at BAVO Europoort in Rotterdam and Antesgroep in Rotterdam (Netherlands)

When is the study starting and how long is it expected to run for?
September 2015 to January 2019

Who is funding the study?
Netherlands Organization for Scientific Research

Who is the main contact?
Dr Roos Ruijne

Trial website

Contact information



Primary contact

Dr Roos Ruijne


Contact details

's Gravendijkwal 230
+31 (0)645 089 003

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Reduction of domestic violence against psychiatric patients: the BRAVE study, a cluster randomized controlled trial


BRAVE (Better Reduction trough Assessment of Violence and Evaluation)

Study hypothesis

Primary hypothesis: the intervention will be associated with a significantly higher detection – and referral rate of domestic violence (DV) in the intervention teams compared with the control teams.

Ethics approval

Medical Ethics Committee Erasmus Medical Center, 07/07/2015, MEC-2015-409

Study design

Multi-center cluster randomised controlled trial

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

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


Domestic violence against psychiatric patients


The proposed intervention consists of:
1. A training for clinicians (social psychiatric nurses, social workers, psychiatrists, psychologists) working in CMH services (FACT) teams , of 8 hours using the LARA training manual (Howard et al., 2013) but modified for the Dutch setting, and training materials on DV already used by DV and CMH services (see ‘Toolkit Meldcode Huiselijk Geweld en Kindermishandeling’ and ‘Toolkit implementatie meldcode’). The training will comprise:
1.1. Identification of DV by a clinician interviewing the patient and standardized risk taxation instruments, e.g. the Dutch DV screening instrument(s) developed by Verwey-Jonker institute (Tan & Verwijs, 2012), and comprehensive risk assessment
1.2. Appropriate initial response to disclosure of DV
1.3. Referral pathway to specialized public DV services
1.4. Knowledge of available specialized local and national services regarding DV
1.5. Knowledge on legislative measures available to prevent DV
1.6. Explanation on the guidelines for DV (NVvP, 2009)
1.7. Clinical techniques on how to support victims of DV
1.8. Personal safety (for patient and clinician)
1.9. Role playing for interviewing the patients
1.10. A training for clinicians on the use of self-help methods for victims of DV a ‘Spiraal van Geweld’ (Groen & Van Lawick, 2008).A violence manual for clinicians, incorporating good practice guidance and local/national DV services (in Dutch: sociale kaart)
2. A training for municipal DV professionals of 6 hours on:
2.1. Mental illness, including definitions of disorders, treatments and service provisions
2.2 Knowledge of DV experts/expertise available in MHC services
2.3. Personal safety (for patient and professional)
3. Provision of integrated service on DV for PPs, modified for this study and delivered by both the DV service professionals and CMH service clinicians (collaborative effort). Integrated care will comprise emotional and practical support, including DV education, facilitation of support groups, safety planning and legal/housing support. A named DV professional will be available to discuss cases, take referrals, feed outcomes back to the MHC team and to regularly attend meetings.

Intervention type



Drug names

Primary outcome measure

1. Number of detected cases of DV per team at 6 and 12 months following training
2. Number of referrals to public DV services per team at 6 and 12 months following training

Secondary outcome measures

1. Whether the training program increases the skills and knowledge regarding DV of the professionals, as compared to the professionals in the control condition, on short – and long term will be assessed using a structured questionnaire (PREMIS). The parameter will be the mean total score of the PREMIS, aggregated per team at 6 and 12 months following training
2. Feasibility, sustainability and acceptance will be assessed in detail using a qualitative method (e.g. semi-structured in-depth interview) for which no parameters are set

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. MHC teams must be FACT teams employed by BAVO Europoort or the Antes Groep
2. Provide care to adult SMI patients (>18 years) in the Rotterdam-Rijnmond area
3. A functioning electronic patient file system, with at least 12 months of historical data

Participant type

Health professional

Age group




Target number of participants

24 FACT teams and all the teams specialized in domestic violence at the Muncipal Health Service in Rotterdam

Participant exclusion criteria

1. Provide care outside the Rotterdam-Rijnmond area
2. Provide care to patients younger than 18 years
3. Consist of clinicians that are employed by more than one team
4. No functioning electronic patient file system
5. Less than 12 months of historical data in the electronic patient file system

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Prins Constantijnweg 48
3066 TA

Trial participating centre

Postbus 800
3170 DZ

Trial participating centre

GGD Rijnmond
Schiedamsedijk 95
3011 EN

Sponsor information


Erasmus MC

Sponsor details

's Gravendijk wal 230

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Nederlandse Organisatie voor Wetenschappelijk Onderzoek

Alternative name(s)

Netherlands Organisation for Scientific Research, Dutch National Scientific Foundation, Dutch National Science Foundation, NWO

Funding Body Type

government organisation

Funding Body Subtype

National government



Results and Publications

Publication and dissemination plan

Trial results will be published in scientific journals. Additionally main results will be communicated to the participating mental health institutions. The researchers intend to send the protocol paper for publication in June 2017. The main paper will be written in December 2018.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Roos Ruijne (

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

2017 protocol in:

Publication citations

Additional files

Editorial Notes

09/08/2017: Publication reference added. 08/06/2017: The publication and dissemination plan and IPD sharing statement have been added. 29/03/2016: Ethics approval information added.