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
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
-
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.
-
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.