Condition category
Mental and Behavioural Disorders
Date applied
15/10/2006
Date assigned
06/02/2007
Last edited
03/05/2011
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
W6 8RP
United Kingdom
+44 (0)20 7386 1237
p.tyrer@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

M0007161104

Study information

Scientific title

Acronym

NIDO-ASPD

Study hypothesis

The qualitative component of the study will explore the relationship between the process of nidotherapy and the outcome measures assessed in the main project. A researcher independent of the main trial will complete a series of key informant interviews aimed at identifying themes. This will be followed by in depth interviews with patients and key workers. Eight study participants will be purposely selected ensuring that a range of demographic and clinical factors are covered (e.g. male and female service users, white and Black and Minority Ethnic [BME] service users and those who were initially treatment seeking and treatment resistant). Questioning will be structured by the researcher to ensure coverage of key themes but will also be responsive to issues that emerge from respondents’ accounts.

We will also collect data from non-participant observation of therapy sessions. This will help the researcher to be aware of differing views, interests and perspectives of the participants and help elucidate accounts of the process given in interviews. All interviews will be tape-recorded and verbatim transcripts made. When patients decline to give consent for interviews consent will be sought form verbatim note taking. Data will be downloaded for analysis using the NVivo computer package.

The hypotheses of this trial are:
1. To determine if nidotherapy is an acceptable form of treatment in forensic settings for both patients and therapists
2. To test whether there are changes in aggressive behaviour, engagement and functioning after nidotherapy and the time scale of such changes
3. To determine if resistance to change in personality is reduced by nidotherapy (as measured by change from Type R to Type S personalities)
4. To determine whether nidotherapy is an appropriate treatment to test in a large randomised controlled trial in forensic patients

Ethics approval

Brent Medical Ethics Committee on the 28/02/2005 (ref: 05/Q0408)

Study design

Observational study with assessments at baseline and up to six months together with qualitative analysis

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Antisocial personality disorder in conjunction with any major mental illness

Intervention

Up to 12 sessions of nidotherapy over a six month period given by a trained nidotherapist.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Change in scores on Modified Overt Aggression Scale (MOAS) after six months from baseline.

The primary objectives of the analysis will be:
1. To describe the processes involved in nidotherapy and which aspects of strategy and approach are most often used
2. To assess from the perspective of service users about the benefits and dis-benefits of this complex intervention and the factors that may promote successful therapy

Secondary outcome measures

To measure changes in personality treatment seeking, engagement, severe episodes of aggression and social functioning after six months.

Overall trial start date

01/04/2005

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

All patients attending a range of local secure and assertive outreach services in the London Boroughs of Brent and Hammersmith and Fulham are considered for intervention with nidotherapy if they satisfy the following inclusion criteria:
1. Written informed consent for treatment, assessment and examination of case records
2. A diagnosis of any mental state (Axis 1) psychiatric disorder and a personality disorder after assessment using the OPCRIT system (mental state diagnosis) and personality disorder (after assessment with the Personality Assessment Schedule (PAS)
3. Evidence they are likely to stay in the relevant area for a period of at least six months (i.e. are not likely to have a major forced environmental change such as imprisonment)
4. Agreement for at least some nidotherapy treatment sessions to be audio-taped

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant exclusion criteria

None if all above satisfied.

Recruitment start date

01/04/2005

Recruitment end date

31/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Psychological Medicine
London
W6 8RP
United Kingdom

Sponsor information

Organisation

National Programme on Forensic Mental Health Research and Development (UK)

Sponsor details

University of Liverpool
C/O HaCCRU
Thompson Yates Building
Quadrangle
Brownlow Hill
Liverpool
L69 3GB
United Kingdom
+44 (0)151 794 5251
k.harney@liverpool.ac.uk

Sponsor type

Research organisation

Website

http://www.nfmhp.org.uk/

Funders

Funder type

Research organisation

Funder name

National Programme on Forensic Mental Health Research and Development (UK) (ref: M0007161104)

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19592427

Publication citations

  1. Results

    Spencer SJ, Rutter D, Tyrer P, Integration of nidotherapy into the management of mental illness and antisocial personality: a qualitative study., Int J Soc Psychiatry, 2010, 56, 1, 50-59, doi: 10.1177/0020764008095934.

Additional files

Editorial Notes