Condition category
Mental and Behavioural Disorders
Date applied
22/11/2012
Date assigned
30/11/2012
Last edited
12/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
First-episode psychosis refers to the first time someone experiences psychotic symptoms or a psychotic episode. Young people are particularly vulnerable to developing psychosis; symptoms can be very disturbing and confusing and can include hallucinations, delusions and feelings of paranoia. Distress may be further increased by negative myths and stereotypes that are present in our society about mental illness. International studies have shown that some young people with psychosis can experience long delays in getting treatment (duration of untreated psychosis or DUP). Such delays can have important consequences for their treatment response and long-term outcome. The main sources of long delays are often due to poor help-seeking behaviour and delays within mental health services themselves, suggesting the need for greater focus on the sources of these delays in tackling them. The aim of this study is to reduce these long delays (or DUP) and improve the care pathways of young people experiencing first-episode psychosis by carrying out a psychosis awareness public health campaign which will run alongside a new ‘youth access’ mental health service. These interventions will provide information and guidance on when, where and how to seek help for psychosis, and provide a single referral point for young people with first-episode psychosis, to ensure they receive care from a youth sensitive team and guarantee direct access to a specialised service.

Who can participate?
The psychosis awareness campaign is aimed at young people (aged 14 – 30) in the south of Birmingham who may be experiencing symptoms of psychosis, their carers and those who work with young people, to raise awareness and provide information about when, where and how to seek help. Alongside provision of a bespoke youth mental health website (www.youthspace.me/psychosis) and a psychosis information line, the campaign will use media, advertising and community events to engage with the south Birmingham community, situating itself in local shopping centres, supermarkets and employment centres. It will also collaborate with youth, community and education groups.

What does the study involve?
The youth access team will operate alongside existing CMHTs in the south of Birmingham to provide direct referral channels and immediate assessments for all young people presenting to primary care with mental health difficulties. DUP and numbers of young people with first-episode psychosis entering the youth access team from the intervention area will be compared with the DUP and numbers of young people with first-episode psychosis entering services from the rest of Birmingham.

What are the possible benefits and risks of participating?
There are no risks from participation as DUP is routinely collected at entry into specialist services as part of initial assessments of all young people with first-episode psychosis.

Where is the study run from?
The awareness campaign and the youth access team are both based in south Birmingham and will operate as a pilot study which will inform a definitive trial.

When is the study starting and how long is it expected to run for?
The study began in January 2012 and will run for 18 months.

Who is funding the study?
The study is funded by the National Institute of Mental Health (UK).

Who is the main contact?
Dr Charlotte Connor
c.s.connor@bham.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Max Birchwood

ORCID ID

Contact details

University of Birmingham
School of Psychology
Frankland Building
Edgbaston
Birmingham
B15 2TT
United Kingdom
m.j.birchwood.20@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Don’t turn your back on the symptoms of psychosis: a proof-of-principle, quasi-experimental public health trial to reduce the duration of untreated psychosis in Birmingham, UK.

Acronym

Study hypothesis

Will implementation of a psychosis awareness public health campaign, in addition to a youth access pathway for first episode psychosis, significantly reduce duration of untreated psychosis (DUP).

Ethics approval

Not provided at time of registration

Study design

This is a quasi-experimental, proof-of-principle prospective trial comparing an intervention area in the south of the city, to the non-intervention remainder of the city.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

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

Condition

First-episode psychosis

Intervention

1. Psychosis Awareness Campaign
To improve the help-seeking of young people and their carers, who are experiencing symptoms of first-episode psychosis providing information about when, where and how to seek help. Individuals are encouraged to access a helpline and a bespoke website.
The campaign will comprise of the following elements:
1.1. Advertising in high use settings.
1.2. Leaflet drops
1.3. Advertising in community press
1.4. Advertising on community websites
1.5. Attendance at community events
1.6. Promotion of www.youthspace.me/psychosis
1.7. The Psychosis Information line
1.8. Youth Advisors
1.9. Psychosis Awareness Training
2. Youth mental health care pathway - to improve the care pathway.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

DUP is routinely assessed for all young people entering services as part of their clinical assessment. Incident cases of first episode psychosis will be determined and their DUP and care pathways ascertained over the 18 months period.

Secondary outcome measures

1. Increase in referrals of young people diagnosed with a psychotic disorder from the intervention area into EIS.
2. We also benefit from historical DUP data (National EDEN) 19 (August 2005 – June 2009) for both target and control areas

Overall trial start date

07/01/2012

Overall trial end date

07/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All new cases of first episode psychosis accepted by the Early Intervention in psychosis Service.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A proof-of–principle trial, key outcome will be an estimate for a definitive trial. The population of our intervention are the size of the community we are trying to target (308,150)

Participant exclusion criteria

Patients considered at ultra-high risk of psychosis are excluded. Since this is a pragmatic trial focussing on reducing DUP in patients managed within an EIS, there will be no other exclusions

Recruitment start date

07/01/2012

Recruitment end date

07/09/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

National Institute of Health Research [NIHR] (UK)

Sponsor details

Room 132
Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom
enquiries@nihr.ac.uk

Sponsor type

Government

Website

http://www.nihr.ac.uk/

Funders

Funder type

Government

Funder name

NIHR CLAHRC Programme for Birmingham and the Black Country (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23432935

Publication citations

  1. Protocol

    Connor C, Birchwood M, Palmer C, Channa S, Freemantle N, Lester H, Patterson P, Singh S, Don't turn your back on the symptoms of psychosis: a proof-of-principle, quasi-experimental public health trial to reduce the duration of untreated psychosis in Birmingham, UK., BMC Psychiatry, 2013, 13, 67, doi: 10.1186/1471-244X-13-67.

Additional files

Editorial Notes