Condition category
Mental and Behavioural Disorders
Date applied
15/10/2006
Date assigned
06/02/2007
Last edited
08/06/2011
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 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 Mary’s 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 measures

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

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

http://www.cnwl.org/index.html

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19526744

Publication citations

  1. 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.

Additional files

Editorial Notes