Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/05/2010
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 Thomas Craig

ORCID ID

Contact details

Kings College London
4th Floor
North Wing
St Thomas Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7928 9292/3771
t.craig@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC01657

Study information

Scientific title

Acronym

Study hypothesis

The objective is to investigate whether patients randomly allocated to the Early Psychosis Service have better social and clinical outcomes than those managed by standard community teams. The primary outcomes are relapse, readmission and detention. Secondary outcomes of interest will include clinical and social functioning, user and carer satisfaction and burden. The research will also assess fidelity to the ACT model and describe team and services processes, training and any adaptations of the model needed to target early psychosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Schizophrenia and other psychoses

Intervention

1. Experimental group: will receive care from the Early Psychosis Service (a multi professional Assertive Community Treatment team targeted at people suffering their first or second episode of psychotic illness
2. Control group: will receive standard care as currently delivered though existing Sector Teams for the catchment areas

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Relapse, readmission and detention at 18 months. We define relapse as any case noted record of a change in clinical state that has resulted in an increase in psychotrophic medication and/or an admission to hospital.

Secondary outcome measures

Secondary outcome measures will include a range of clinical social and service use outcomes:
1. Clinical measures at all three time points:
1.1. Brief psychiatric rating scale (BPRS)
1.2. Positive and negative syndrome scale (PANSS)
1.3. Global Assessment of Functioning (GAF) scale
1.4. Calgary Depression Scale
1.5. Insight Scale
1.6. Treatment compliance at 6 and 18 months
2. Social functioning at all three time points:
2.1. Employment status
2.2. Housing status
2.3. Benefit uptake
2.4. Social network scale
2.5. Life Skills Profile (LSP)
3. Patient and carer satisfaction/burden:
3.1. Verona satisfaction scale
3.2. Family burden at 18 months
4. Service use and costs: assessed retrospectively at 18 months based on a combination of service records and a standard instrument - the Client Service Receipt Inventory. Resource use will be identified for both treatment and control group and will include:
4.1. Medication costs
4.2. NHS services
4.3. Local authority services accommodation
4.4. Contact with criminal justice and all other services
4.5. Indirect economic impacts (particularly lost employment and caregiver burden) will also be included.
5. Team process measures and fidelity - team activity logs e.g.:
5.1. Contacts per client
5.2. Out of hours contacts
5.3. Interventions offered
5.4. Adherence to ACT model

Overall trial start date

01/01/2000

Overall trial end date

01/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 - 35 years
2. Living in the catchment areas served by the team (pop. approx 150,000)
3. Presenting with a first or second episode of a psychotic disorder (International Statistical Classification of Diseases and Related Health Problems, tenth edition [ICD-10] schizophrenia spectrum disorder including unspecified non-organic psychosis)

Every effort will be made to include as many eligible patients as possible. For example, assistance of interpreters associated with the clinical service will be enlisted in order to include patients whose first language is not English..

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

Patients with primary substance use disorder will not be eligible for the study.

Recruitment start date

01/01/2000

Recruitment end date

01/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Kings College London
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London (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

1. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15485934
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20435962

Publication citations

  1. Results

    Craig TK, Garety P, Power P, Rahaman N, Colbert S, Fornells-Ambrojo M, Dunn G, The Lambeth Early Onset (LEO) Team: randomised controlled trial of the effectiveness of specialised care for early psychosis., BMJ, 2004, 329, 7474, 1067, doi: 10.1136/bmj.38246.594873.7C.

  2. Results

    Gafoor R, Nitsch D, McCrone P, Craig TK, Garety PA, Power P, McGuire P, Effect of early intervention on 5-year outcome in non-affective psychosis., Br J Psychiatry, 2010, 196, 5, 372-376, doi: 10.1192/bjp.bp.109.066050.

Additional files

Editorial Notes