Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Conflicts and aggression incidents occur frequently on psychiatric hospital wards. In general professionals try to calm down the situations with communication methods. As a last resort, coercive measures are applied. Due to legal and ethical reasons coercive measures are used restrictively. Professionals regularly receive training to manage aggression incidents and coercive measures. However, training mostly focuses on situations which are in an advanced state of escalation. Often they aim to enable a clear procedure in the case of overpowering and a controlled approach in the case of coercive measure. The procedures aim to resolve the situation in the least damaging way, both for the patients and for the employees. The Safewards model explains how aggression incidents, violence and coercive measures and their influencing factors are linked. According to the model, professionals should intervene much earlier in the process of escalation, and that a good relationship and communication skills as well as safe atmosphere on psychiatric wards may improve the prevention of aggression and coercive measures. Ten interventions were developed and tested successfully in a big study in psychiatric wards around London. Another effort on this topic was the developed of a scale (the Bern Psychopathology Scale (BPS)) by a research group in Bern. This scale helps to identify illness symptoms of three relevant communication domains (affectivity, language and motor behavior). With this information, professionals can focus their communication on the healthy domain. The idea is to avoid misunderstandings potentially leading to aggressions and violence. However, the effectiveness of this communication approach at reducing aggression and coercion has not been investigated before. Moreover it is unclear whether the Safewards interventions are effective in Swiss psychiatric wards. The aim of this study is to test the Safewards intervention in Swiss psychiatric wards and for the first time, communications training based on the mentioned Bern psychopathology scale.

Who can participate?
Staff and patients in acute psychiatric wards

What does the study involve?
Participating wards are randomly allocated either to the Safewards intervention group or the control group (treatment as usual). Both interventions focus on the training of the professionals. Patients are not actively involved, but they receive potentially better care due to better trained staff. The Safewards intervention includes the training and support of the staff during the implementation of the ten Safewards interventions. These include simple behaviour recommendations and training for the employees on the subject of conflict management, and measures for improving the relationships among patients as well as among the professionals in the normal daily life and when problems arise. All interventions and support measures are described comprehensively on the website The scale-based communication training includes training the employees how to assess patients with the BPS Scale as well as assistance and support in the training of communication strategies. The staff of the two control wards receive brief oral and written information on aggression and coercion. The intervention phase lasts 4 to 12 months. The number of aggression events and the use of coercive measures are recorded. Group interviews with patients and staff take place on the intervention wards at the end of the training or intervention in order to gain a better understanding of their experiences.

What are the possible benefits and risks of participating?
Because the interventions are staff-related and the intervention focuses on minimising the risks of aggression incidents and coercive measures, no direct risks are expected. In case of ineffective interventions the usual risks of a psychiatric in-patient treatment can be expected, which are unrelated to the interventions. It is possible that individual patients consider individual interventions like a mutual help meeting (an example of a safewards intervention) as not helpful or that they reject them, as is usual in mental health practice.

Where is the study run from?
University Hospital of Psychiatry and Psychotherapy Berne (Switzerland)

When is the study starting and how long is it expected to run for?
May 2016 to January 2019

Who is funding the study?
University Hospital of Psychiatry and Psychotherapy Berne (Switzerland)

Who is the main contact?
Christian Burr

Trial website

Contact information



Primary contact

Mr Christian Burr


Contact details

UPD Bern
Bolligenstrasse 111
Berne 60
+41 (0)31 930 97 12



Additional contact

Prof Sebastian Walther


Contact details

UPD Bern
Murtenstrasse 21
Berne 60

Additional identifiers

EudraCT number number

Protocol/serial number

Quantitative Part of the Study: Reg-2016-00513; Qualitative Part of the Study: Reg-2017-00846

Study information

Scientific title

A project to deal with and reduce coercion and aggression on acute psychiatric wards



Study hypothesis

On acute psychiatric wards, where the Safewards intervention or BPS intervention are implemented, the frequency of coercion and aggression events will decrease during and after the implementation phase in comparison to the control group

Ethics approval

Ethics Board of the canton of Berne (Switzerland, swissethics), 16/09/2016, Quantitative Part of the Study: Reg-2016-00513; Qualitative Part of the Study: Reg-2017-00846

Study design

Single-centre three-armed cluster-controlled intervention study

Primary study design


Secondary study design

Cluster randomised trial

Trial setting


Trial type


Patient information sheet

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


Coercion and aggression on acute psychiatric wards


Stratified cluster randomisation was used. The six recruited wards were divided up in two as equal as possible groups regarding the length of average stay, frequency of involuntary admissions and number of seclusion rooms. Then from each group there was a concealed allocation to the following three groups:

1st Intervention: Training and supporting the staff to implement the 10 Safewards interventions. These include simple behavioural tips and training for staff on the topic of de-escalation and conflict management, activities to improve the relationship between patients and staff in everyday life and in problem situations like: weekly support conferences, systematic supportive conversations before or after negative events, as well as hopeful actions regarding the current, but also future situation of the patients, for example with the hopeful discharge messages from patients leaving the ward. All interventions are comprehensively described on the website

2nd Intervention: Training and supporting of staff implementing of the communication strategies based and focused on the domains of the Bern Psychopathology Scale (BPS). The BPS is a clinical rating scale developed to group psychotic symptoms in the domains of language, affectivity and motor behavior. These domains are of particular interest for understanding the fundamental communication breakdown during psychotic disorders, since they can be linked to known, higher order brain systems, i.e. the language, the limbic and the motor system. The intervention gives a training to recognize the well-functioning domain and to focus the communications skills on this domain.

Control: Short verbal and written information on the topic of coercion and aggression as well as attaching pictures to aims and intervention of the project at the corresponding wards.

Follow-up measures are planned for all arms 6 months after finishing the implementation of the interventions.

Intervention type



Drug names

Primary outcome measures

Freedom restrictive interventions, measured using the electronic patient record at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)

Secondary outcome measures

1. Aggressive events, measured using the EVA Form (part of the electronic patient record) at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)
2. The percentage of hours/days during which the doors of the wards were open, at baseline (15/12/2016-15/04/2017), T1 (01/09/2017-30/12/2017), T2 (01/04/2018-30/07/2018), follow-up (01/01/2019-30/04/2019)
3. Perspectives of staff and patients related to the experience on the intervention wards, evaluated in focus group interviews at the end of the intervention phase (01/06/2018-01/08/2018)

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Acute psychiatric ward with admission obligation
2. The positions of the senior physician and the nursing ward manager are filled
3. Adequate data quality from the outcome parameters to be collected during the last 6 months

Participant type

Health professional

Age group




Target number of participants

6 wards with approximately 120 staff and 2200 patients

Participant exclusion criteria

1. Wards with specialized therapeutic regimen where patients are admitted only with special indication
2. Day clinics

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University Hospital for Psychiatry and Psychotherapy
Bolligenstrasse 111
Berne 60

Sponsor information


University Berne Psychiatric Services Inc

Sponsor details

University Hospital of Psychiatry and Psychotherapy
Bolligenstrasse 111
+41 (0)31 930 91 11

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

University Berne Psychiatric Services Inc. University Hospital of Psychiatry and Psychotherapy

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

All documents and study information can be requested from Christian Burr. Planned publication in a high-impact peer reviewed journal around end of 2019.

IPD sharing statement
Because the trialists have data from the medical record, they are not allowed to make the original data available. The anonymized data can be provided as an Excel or SPSS file. For this please contact Christian Burr. The data is stored securely in the Unit for R&D in Nursing of the University Hospital for Psychiatry and Psychotherapy in Berne (CH).

Intention to publish date


Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes