Contact information
Type
Scientific
Primary contact
Prof Peter Tyrer
ORCID ID
Contact details
Department of Psychological Medicine
Imperial College
St Dunstan's Road
London
W8 8RP
United Kingdom
+44 (0)20 7386 1237
p.tyrer@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
site/DNMM06
Study information
Scientific title
Acronym
SITE
Study hypothesis
To test the feasibility and likely effectiveness of nidotherapy, a new treatment for personality disorder and chronic mental illness, in a group that is most difficult to treat - those cared for by an assertive outreach team, in an exploratory randomised controlled trial.
Ethics approval
St Marys Hospital Research Ethics Committee on 16/07/2003 (ref: R&D03/X008E).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Co-morbid personality disorder and severe mental illness (schizophrenia, bipolar disorder or severe depressive illness)
Intervention
Nidotherapy (a new treatment designed to change the environment to suit the needs of the peson with the chronic disorder) versus assertive treatment as usual in the team.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Reduction of usage of psychiatric beds one year after treatment
Secondary outcome measures
1. Reduction in number of admissions
2. Social function (using the Social Functioning Questionnaire)
3. Psychiatric symptomatology (using Brief Psychiatric Rating Scale [BPRS])
4. Patient satisfaction (Consultation Satisfaction Questionnaire [CSQ])
5. Engagement with services (Engagement and Acceptance Scale [EAS])
Overall trial start date
01/10/2003
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Randomisation of all eligible patients who give consent currently under the care of an assertive outreach team.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
52
Participant exclusion criteria
Those who refuse to take part.
Recruitment start date
01/10/2003
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Psychological Medicine
London
W8 8RP
United Kingdom
Sponsor information
Organisation
Central North West London Mental Health NHS Trust (UK)
Sponsor details
30 Eastbourne Terrace
London
W2 6LA
United Kingdom
+44 (0)20 8237 2000
david.slater@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Nicola Pigott Memorial Fund (UK) (ref: CNWL019070)
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19526744
Publication citations
-
Results
Ranger M, Tyrer P, Miloseska K, Fourie H, Khaleel I, North B, Barrett B, Cost-effectiveness of nidotherapy for comorbid personality disorder and severe mental illness: randomized controlled trial., Epidemiol Psichiatr Soc, 18, 2, 128-136.