Condition category
Mental and Behavioural Disorders
Date applied
28/05/2010
Date assigned
28/05/2010
Last edited
25/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Jones

ORCID ID

Contact details

Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
-
pbj21@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7036

Study information

Scientific title

LEGS Cluster Randomized Trial: Liaison with Education and General Practices to Detect and Refine Referrals of People with At-Risk-Mental-States (ARMS)

Acronym

LEGS Trial: Liaison with PCPs and HEIs to Refine Referrals of ARMS

Study hypothesis

In order to do really early intervention in psychosis we need to find people early, those with At-Risk-Mental-States (ARMS) of developing such illness. International efforts to decrease the stigma of psychosis and solicit self- and other referrals have exploited print and television media for public information campaigns, as well as educating members of relevant occupational groups. The Norwegian 'TIPS' projects and the Australian ORYGEN/PACE are exemplars regarding ARMS detection; neither of them was a randomised design for ARMS, nor did they use propensity or other appropriate methods to compare areas with and without the intervention. TIPS has no economic evaluation but is certainly very expensive. There was evidence that existing cases of psychosis (with long duration of untreated psychosis) were found, but it was less clear what worked in terms of finding ARMS. Influential work in Denmark and Australia has also taken this approach.

Ethics approval

MREC approved (ref: 09/H0304/46)

Study design

Multicentre randomised interventional diagnosis, prevention and treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Condition

Topic: Mental Health Research Network, Primary Care Research Network for England; Subtopic: Schizophrenia, Not Assigned, Psychosis, Service Delivery; Disease: Schizophrenia, Psychosis, All Diseases

Intervention

We are going to test whether a simple 'postal' campaign coordinated from an office is more effective and cost-effective than a more elaborate system of personal liaison by a health professional with the Primary Care Practices [PCPs] and the Higher Education Institutions [HEIs], as has been deployed in the international work cited above: a low versus high intensity strategy.

Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Yield in terms of ARMS referrals

Secondary outcome measures

Comparison of referral rates

Overall trial start date

22/12/2009

Overall trial end date

06/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Liaison phase:
1. PCPs and HEIs in Cambridgeshire and Peterborough areas
2. Signed agreement form from PCPs Partners and HEIs

Follow-up phase (at-risk-mental-states' data collection):
3. Patients confirmed as at-risk-mental-states for psychosis after being previously identified by PCPs and/or HEIs
4. Informed consent signed for data collection

All:
5. Male and female, aged 16 years or older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 90; UK sample size: 90

Participant exclusion criteria

Lack of mental capacity to provide informed consent

Recruitment start date

22/12/2009

Recruitment end date

06/05/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

Cambridgeshire and Peterborough NHS Foundation Trust (UK)

Sponsor details

Cambridge Road
Fulbourn
Cambridge
CB21 5EF
United Kingdom

Sponsor type

Government

Website

http://www.cpft.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK)

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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/23866815
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26296562

Publication citations

  1. Protocol

    Perez J, Russo DA, Stochl J, Byford S, Zimbron J, Graffy JP, Painter M, Croudace TJ, Jones PB, Comparison of high and low intensity contact between secondary and primary care to detect people at ultra-high risk for psychosis: study protocol for a theory-based, cluster randomized controlled trial., Trials, 2013, 14, 222, doi: 10.1186/1745-6215-14-222.

  2. Results

    Perez J, Jin H, Russo DA, Stochl J, Painter M, Shelley G, Jackson E, Crane C, Graffy JP, Croudace TJ, Byford S, Jones PB, Clinical effectiveness and cost-effectiveness of tailored intensive liaison between primary and secondary care to identify individuals at risk of a first psychotic illness (the LEGs study): a cluster-randomised controlled trial, Lancet Psychiatry, 2015 , doi: 10.1016/S2215-0366(15)00157-1.

Additional files

Editorial Notes