Systematic Intervention to Transform Environment: a randomised controlled trial of nidotherapy in an assertive outreach team

ISRCTN ISRCTN73227556
DOI https://doi.org/10.1186/ISRCTN73227556
Protocol serial number site/DNMM06
Sponsor Central North West London Mental Health NHS Trust (UK)
Funder Nicola Pigott Memorial Fund (UK) (ref: CNWL019070)
Submission date
15/10/2006
Registration date
06/02/2007
Last edited
08/06/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Tyrer
Scientific

Department of Psychological Medicine
Imperial College
St Dunstan's Road
London
W8 8RP
United Kingdom

Phone +44 (0)20 7386 1237
Email p.tyrer@imperial.ac.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymSITE
Study objectivesTo 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(s)St Mary’s Hospital Research Ethics Committee on 16/07/2003 (ref: R&D03/X008E).
Health condition(s) or problem(s) studiedCo-morbid personality disorder and severe mental illness (schizophrenia, bipolar disorder or severe depressive illness)
InterventionNidotherapy (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 typeOther
Primary outcome measure(s)

Reduction of usage of psychiatric beds one year after treatment

Key secondary outcome measure(s)

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])

Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration52
Key inclusion criteriaRandomisation of all eligible patients who give consent currently under the care of an assertive outreach team.
Key exclusion criteriaThose who refuse to take part.
Date of first enrolment01/10/2003
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Department of Psychological Medicine
London
W8 8RP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2009 Yes No