The effect of nidotherapy on antisocial behaviour and attitudes to intervention

ISRCTN ISRCTN96256106
DOI https://doi.org/10.1186/ISRCTN96256106
Secondary identifying numbers 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

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

Study information

Study designObservational study with assessments at baseline and up to six months together with qualitative analysis
Primary study designObservational
Secondary study designSingle-centre
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymNIDO-ASPD
Study objectivesThe 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) studiedAntisocial personality disorder in conjunction with any major mental illness
InterventionUp to 12 sessions of nidotherapy over a six month period given by a trained nidotherapist.
Intervention typeOther
Primary outcome measureChange 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 measuresTo measure changes in personality treatment seeking, engagement, severe episodes of aggression and social functioning after six months.
Overall study start date01/04/2005
Completion date31/03/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants40
Key inclusion criteriaAll 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 criteriaNone if all above satisfied.
Date of first enrolment01/04/2005
Date of final enrolment31/03/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Psychological Medicine
London
W6 8RP
United Kingdom

Sponsor information

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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
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