Condition category
Mental and Behavioural Disorders
Date applied
30/11/2009
Date assigned
15/01/2010
Last edited
29/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The benefit of psychiatric treatment is strongly influenced by the quality of the relationship between the psychiatrist and the patient. This can be an even stronger effect than the effect of medication or other treatments. The quality of psychiatrist-patient communication also influences adherence to treatment. However, communication often breaks down in consultations with psychotic patients because their unusual experiences (e.g., hallucinations, delusions) lie outside of ordinary human experience. Until recently, there was a lack of evidence about good communication with such patients. In previous studies we have shown that effective psychiatrist communication with psychotic patients depends on how well psychiatrists try to understand the patient’s psychotic experiences. Moreover, we have shown that this leads to a better patient outcome (i.e., higher patient satisfaction), a better therapeutic relationship and treatment adherence, and fewer relapses. We will use our findings to develop a new intervention to train psychiatrists in communicating with patients who experience hallucinations and delusions. The training package will be developed with and delivered in collaboration with service users and psychiatrists. Psychiatrists will learn specific communicative strategies to help them reach a shared understanding with their patients about psychotic symptoms. We will test the training package to assess feasibility and determine how we could conduct a larger study using these methods. We will identify whether psychiatrists can improve their communication skills through training, whether they can use these skills appropriately in consultations with psychotic patients, and whether this improves patient clinical outcomes.

Who can participate?
Higher/advanced psychiatric trainees and patients aged 18 - 65 with schizophrenia or schizoaffective disorder.

What does the study involve?
Psychiatrists are randomly allocated to one of two groups. One group undergoes the training programme and the other does not. The training programme consists of four training sessions taking place one week apart and lasting 4 hours each. During the training period, at least one consultation with a participating patient per psychiatrist is recorded for training purposes. These consultations are viewed and psychiatrists receive and discuss feedback in the training sessions. There are also follow-up sessions four and eight weeks after the fourth training session. At the end of the training the next consultation between each participating psychiatrist and patient is recorded and assessed.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Newham Centre for Mental Health, East London NHS Foundation Trust and North East London NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
March 2010 to March 2013

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Rose McCabe
r.mccabe@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rose McCabe

ORCID ID

http://orcid.org/0000-0003-2041-7383

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
Glen Road
London
E13 8SP
United Kingdom
-
r.mccabe@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0408-16279

Study information

Scientific title

Developing and piloting a new intervention to improve psychiatrist-patient communication about psychosis: an exploratory cluster-randomised controlled trial

Acronym

Study hypothesis

We wish to address the following research questions:
1. Can psychiatrists learn to use a particular communicative mechanism (repair) to communicate more effectively with patients with psychosis?
2. Can they apply this new way of communicating with their patients?
3. Does it have an effect on the following intermediate outcomes: psychiatrist confidence in communicating with psychotic patients, patient experience of the communication and patient centredness in the first consultation with each relevant patient after the 12 week training period
4. Does it have an effect on the following patient clinical outcomes: patient satisfaction with treatment, the therapeutic relationship, treatment adherence and relapse at 6 months follow-up

Ethics approval

Not provided at time of registration

Study design

Exploratory cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Schizophrenia/schizoaffective disorder

Intervention

Psychiatrists will be randomised to the intervention group (training programme) or control group (no training programme).

Training programme:
The proposed training programme is as follows. Training will be provided by the lead applicant, a psychiatrist and a service user in interactive groups with a maximum of 6 psychiatrists per group. Small groups are to facilitate some one-to-one work with each psychiatrist on their own recorded consultations. There will be 4 training sessions lasting 4 hours each. They will take place one week apart. During the training period, at least one consultation with a participating patient per psychiatrist will be recorded for training purposes. These consultation(s) will be viewed and psychiatrists will receive and discuss feedback in the training sessions. Four weeks after training session 4, there will be one follow-up refresher/supervision session, followed by a final refresher session eight weeks after training session 4. The proposed training schedule is:
1. Training session 1 at baseline
2. Training session 2 after one week
3. Training session 3 after two weeks
4. Training session 4 after three weeks
5. Refresher session after 8 weeks
6. Refresher session after 12 weeks
At the end of the training, the next consultation between each participating psychiatrist and patient will be recorded and communicative behaviours assessed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Psychiatrists use of repair will be assessed using the Repair Protocol, which is a standardised and validated measure.

Secondary outcome measures

Intermediate outcomes:
1. Psychiatrist confidence in communicating with psychotic patients
2. Patient experience of the communication
3. Patient centredness
Measured in the first consultation with each relevant patient after the 12 week training period

Final outcomes:
4. Patient satisfaction with treatment
5. Therapeutic relationship
6. Treatment adherence and relapse
Measured at 6 months follow-up

Overall trial start date

01/03/2010

Overall trial end date

01/03/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Psychiatrists:
Higher/advanced psychiatric trainees (ST4-6) working in outpatients or community mental health teams. Doctors in higher psychiatric training (ST4-6) already have basic knowledge and experience in psychiatry gained through core psychiatric training. During higher training they practice without direct supervision and aim to further develop specific competencies including communication skills. Hence, they are at the formative stage of their training, preparing to take up a consultant role in a few years time. We will focus on trainees in this pilot trial, because the effectiveness of an intervention on changing their communicative practice may be higher at this stage of their professional development.

Patients:
1. ICD-10 criteria for a diagnosis of schizophrenia or schizoaffective disorder
2. Currently attending outpatients or being cared for by community mental health teams
3. Capable of giving informed consent
4. Aged 18 - 65 years, both females and males

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

84 (72 patients and 12 psychiatrists)

Participant exclusion criteria

Patients:
1. Organic impairment
2. Require an interpreter

Recruitment start date

01/09/2011

Recruitment end date

01/10/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newham Centre for Mental Health
London
E13 8SP
United Kingdom

Trial participating centre

East London NHS Foundation Trust
London
E1 8DE
United Kingdom

Trial participating centre

North East London NHS Foundation Trust
Ilford
IG3 8XJ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Queen Mary's Innovation Centre
Lower Ground Floor
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0408-16279)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Manuscript in press

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27445354

Publication citations

Additional files

Editorial Notes

29/07/2016: Publication reference added.