The effect of nidotherapy on antisocial behaviour and attitudes to intervention

ISRCTN	ISRCTN96256106
DOI	https://doi.org/10.1186/ISRCTN96256106
Protocol serial number	M0007161104
Sponsor	National Programme on Forensic Mental Health Research and Development (UK)
Funder	National Programme on Forensic Mental Health Research and Development (UK) (ref: M0007161104)

Submission date: 15/10/2006
Registration date: 06/02/2007
Last edited: 03/05/2011

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
W6 8RP
United Kingdom

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

Study information

Primary study design	Observational
Study design	Observational study with assessments at baseline and up to six months together with qualitative analysis
Secondary study design	Single-centre
Scientific title
Study acronym	NIDO-ASPD
Study objectives	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(s)	Brent Medical Ethics Committee on the 28/02/2005 (ref: 05/Q0408)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	To measure changes in personality treatment seeking, engagement, severe episodes of aggression and social functioning after six months.
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key 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
Key exclusion criteria	None if all above satisfied.
Date of first enrolment	01/04/2005
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Psychological Medicine

London
W6 8RP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2010		Yes	No