Condition category
Mental and Behavioural Disorders
Date applied
18/02/2015
Date assigned
24/03/2015
Last edited
08/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Personality disorder is the name given to describe the persistent problems that some people have in managing their feelings, and managing their feelings in relation to other people. Up to 3% of the general population and up to 63% of offenders suffer from Antisocial Personality Disorder (ASPD). Someone with ASPD may not care about the feeling or rights of other people. Typical features include aggressiveness, failure to follow rules and not respecting the law. Its more severe consequences commonly include violent criminal behaviour with direct emotional and physical injury to victims. ASPD poses a significant health and financial burden both for individuals who have it, and for wider society. People with ASPD are more likely to suffer from additional health problems and are significantly more likely to die at a younger age than people without the disorder. Despite its high prevalence and harmful consequences, there is almost no evidence about which treatments are more effective for ASPD. One possible reason that an effective treatment has not yet been found is that most treatments that have been tested are not specifically designed for ASPD. We aim to test a treatment that has been specifically adapted for ASPD, from a model of treatment known as Mentalization Based Treatment (MBT). MBT is a psychological treatment that focuses on understanding of our own and others’ thoughts, feelings, wishes, dreams and desires. MBT has been shown to be effective in patients with another type of personality disorder called Borderline Personality Disorder (BPD). It has also been shown to be effective in patients who have both BPD and ASPD, and has now been specially adapted for people who suffer from just ASPD. Despite its promise, the question of whether MBT is effective for ASPD has not yet been investigated. The aim of the initial study is to investigate whether MBT can reduce aggressive acts and antisocial behaviour of offenders with ASPD, and whether it does so more effectively and cost-effectively than the usual services offered to offenders on probation. Following this, a full study will be conducted across thirteen sites, which aims to find out the benefits of MBT on a larger scale.

Who can participate?
We are looking for males aged over 21 who are currently on probation or community sentence, have a diagnosis of ASPD and do not want to offend anymore.

What does the study involve?
In both the initial study and the full-scale study, participants are randomly allocated to receive MBT or standard probation as usual (PAU) for 12 months. The MBT involves receiving a monthly 1-hour individual mentalization-based therapy session and a weekly group mentalization-based therapy for 75 minutes. The results of the two groups are compared by asking participants how often they are violent, and look at police records to see if the participant has re-offended. Other possible differences between the two groups such as impact of the treatment on quality of life and social functioning are also examined. Participants are asked these questions every 3 months throughout the year that they receive their treatment (either MBT or PAU), and for 24 months after they have completed treatment. This data is collected by members of the research team through questionnaires and interviews. All the this data is then analysed in order to find out whether the expected benefit of MBT is achieved and whether the treatment would be a more cost-effective option to be used across the country.

What are the possible benefits and risks of participating?
This is the first ever large scale research study of MBT for offenders with ASPD in the community and will provide evidence to inform treatment decisions for this population. The main benefits of the treatment are an expected reduction in aggressive behaviour and therefore a reduction in arrests and offences. All participants will receive help and support during this process. There are no identifiable risks for anyone who wishes to take part in the research.

Where is the study run from?
The pilot study takes place in three probation services in the UK and the full study takes place in 13 services around the UK.

When is the study starting and how long is it expected to run for?
From June 2014 to December 2020

Who is funding the study?
1. The Michael J Samuel Charitable Trust (UK)
2. National Institute for Health Research (UK)

Who is the main contact?
1. Ms Elizabeth Simes
2. Dr Stephen Butler

Trial website

Contact information

Type

Public

Primary contact

Ms Elizabeth Simes

ORCID ID

Contact details

Research Department of Clinical
Educational & Health Psychology
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

Type

Scientific

Additional contact

Dr Stephen Butler

ORCID ID

Contact details

Research Department of Clinical
Educational & Health Psychology
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 3

Study information

Scientific title

Mentalization for Offending Adult Males: A National Randomised Controlled Trial (MOAM)

Acronym

MOAM

Study hypothesis

Pilot study:
The aim of this study is to conduct a feasibility randomised controlled trial (RCT) across four sites in preparation for a larger multi-site RCT to investigate whether MBT adapted for individuals with ASPD (MBT-ASPD) is an effective treatment for individuals with a diagnosis of antisocial personality disorder (ASPD) in the community when compared to probation as usual (PAU).

Randomised controlled trial:
The aim of this study is to conduct a randomised controlled trial (RCT) across thirteen sites in to investigate whether Mentalization Based Therapy (MBT) adapted for individuals with antisocial personality disorder (ASPD) is an effective treatment for individuals with a diagnosis of ASPD in the community when compared to Probation as Usual (PAU).

Ethics approval

Pilot study:
1. NHS Ethics: NRES Committee London - South East, 09/01/2015, REC ref: 14/LO/1696
3. NOMS Ethics: National Research Committee, ref: 2014-315

Randomised controlled trial:
Approval pending

Study design

Pilot study:
Multi-centre pilot two-arm randomized controlled trial

Randomised controlled trial:
Multi-centre three phase pragmatic randomised controlled superiority trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Antisocial personality disorder

Intervention

Pilot study:
Participants will be randomly allocated in a 1:1 ratio to receive Mentalization Based Therapy (MBT) or Probation as Usual (PAU).

MBT arm
Mentalization-based therapy integrates cognitive and relational components of therapy and has a theoretical basis in attachment theory. MBT-ASPD targets mentalizing problems through a programme of group and individual psychotherapy. All participants randomised to MBT-ASPD will have an allocated psychiatrist, a therapist who will provide individual therapy and two group therapists (one of whom will be their individual therapist). The therapist will provide a monthly 1-hour individual mentalization-based therapy session. Participants will also attend weekly group mentalization-based therapy for 75 minutes. Therapy will last for 2 months after which patients will be reassessed by a member of the trial clinical team and referred for further management if required. Each MBT group will have a maximum of 8 participants. The main purpose of MBT-ASPD is to help participants develop an understanding of their difficulties with violence and to achieve control over their aggressive behaviour by stabilizing emotional expression. The MBT-APSD programme aims to develop a therapeutic process in which the offender’s mind becomes the focus of treatment, to enable them to understand more about how they think and feel about themselves and others, and how this influences their actions and behaviours. MBT sessions will focus on identifying the thoughts and feelings associated with aggressive impulses and which may trigger aggressive or violent behaviour, with particular emphasis on (1) understanding emotional cues; (2) recognising emotions in others (3); exploring sensitivity to hierarchy and authority (4); understanding others’ experiences in relation to ones’ own (5); clarifying threats to loss of mentalizing. Sessions will also give participants a place to discuss the difficulties they have experienced in their life which may have contributed to their violent behaviour.

PAU arm
Participants who are randomised to the PAU arm of the trial will remain under the supervision of their Probation Trust for the duration of their licence or community sentence. It is hoped that this will facilitate the participants being available for outcome measures and data collection. Participants will be free to be referred by their Probation Officer for any suitable and appropriate treatments available locally e.g. anger management programmes. However, as there are limited treatments available in the community for people with Antisocial Personality Disorder the participants may not be able to access alternative treatments. In these cases, contact with the Probation Officer may provide an important containing and therapeutic, as well as supervisory, function. Participants will be offered treatment review meetings where appropriate, including medication review, with the Consultant Psychiatrist. Medication use will be monitored carefully and only offered for comorbid conditions according to NICE guidance. In order to address potential bias, site-specific strategies will be put in place to ensure that MBT principles and practice do not directly influence the management of those randomised to PAU. One strategy that will be applied to all sites is that MBT therapists and MBT supervisors will not be allowed to be in contact with participants in the PAU arm of the trial. PAU will last for 12 months, after which participants who still have time remaining on their licence or community sentence will remain under the supervision of their Probation Trust for the duration of their licence or community sentence. It is hoped that this will facilitate the participants’ availability for outcome measures and data collection.

Randomised controlled trial:
Participants will be randomly allocated in a 1:1 ratio to receive Mentalization Based Therapy (MBT) or Probation as Usual (PAU), and will follow the same protocol as the pilot study (see above).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Pilot study and randomised controlled trial:
Frequency of aggressive acts will be measured using a self-report 5-item version of the Overt Aggression Scale Modified at baseline and at every 3 months during treatment (i.e., months 3, 6, 9, and 12) and every 3 months post-treatment for one year (i.e., months 15, 18, 21, and 24).

Secondary outcome measures

Pilot study:
Unless otherwise stated, the secondary outcome measures are collected at baseline and every 6 months during treatment (i.e., months 6 and 12) and every 6 months post-treatment for one year (i.e., months 18 and 24).

1. Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM). A self-report questionnaire designed to be administered before and after therapy. The client is asked to respond to 34 questions about how they have been feeling over the last week, using a 5-point scale ranging from 'not at all' to 'most or all of the time'. The 34 items of the measure cover four dimensions: Subjective well-being, Problems/symptoms, Life functioning, and Risk/harm.
2. Psychopathic Personality Inventory- Revised (PPI-R 154; Lilienfeld, 2005). The PPI-R is a 154-item self-report measure of both global psychopathy and the component traits of psychopathy. Like the original PPI, the PPI-R is construct valid, time efficient, and can detect response styles potentially relevant to psychopathy (i.e. positive or negative impression management, random or careless responding). Rather than focusing exclusively on antisocial or criminal behaviors, the PPI-R measures the continuum of psychopathic personality traits present in a range of individuals and can be used in both clinical (e.g. forensic) and non-clinical (e.g. student, community) settings.
3. MacArthur Community Violence Screening Instrument (MCVSI; Steadman et al., 1998; 2000): 18-item semi-structured interview to measure the frequency with which individuals have been subject to and/or have engaged in particular violent behaviours.
4. Offending behaviour structured interview for offending behaviour designed to record offending activity. Consists of 17 “yes” or “no” self-report response-type questions. Each question is related to a different type of offence (e.g., theft of motor vehicles, shoplifting, possession of an offensive weapon/firearms, and drug offences). Adapted from adapted from the self-report offending questionnaire from the Cambridge study by David Farrington (2006).
5. State Trait Anger Expression Inventory 2 (STAXI-2; Spielberger, 1999): 57-item self-report measure to investigate the experience, expression of anger and control of anger. Comprises of six subscales, including state anger, trait anger, anger expression out, anger expression in, anger control out and anger control in, and anger expression index.
6. Euroqol5 (EQ5D): Standardised self-report instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple 5-item descriptive profile and a single index value for health status.
7. Brief Symptom Inventory (BSI; Derogatis, 1993; Derogatis & Melisaratos, 1983): A short form of the Symptom Checklist90Revised, is a 53-item self-report screening instrument used to assess the psychological symptom patters of the participants. Nine primary symptom scales: Somatization, Obsessive Compulsive, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid Ideation, and Psychoticism.
8. Social Functioning Questionnaire (SFQ; Tyrer et al., 2005): 8-item self-report scale, with items covering the domains of home, work, leisure, and relationships.
9. Barratt Impulsiveness Scale (BIS; Patton et al., 1995): The most widely used self-report measure of impulsive personality traits, consists of 30-items.
10. Alcohol Use Disorders Identification Test (AUDIT; Saunders et al., 1993): 10-item self-report test developed by the World Health Organization to determine if a person's alcohol consumption may be harmful.
11. Drug Use Disorders Identification Test (DUDIT; Berman et al., 2007): 11-item self-report test developed as a parallel instrument to the AUDIT for identification of use patterns and various drug-related problems.
12. Secure Facilities Service Use Schedule (SFSUS; Barrett & Byford, 2007): Researcher is able to collect meaningful individual level service use information for the economic evaluation of services provided within secure facilities. The schedule includes information on the service user’s accommodation, including time spent in a secure facility such as prison or secure NHS unit, use of all health, social, voluntary sector services, psychotropic medication and contact with the police, lawyers and the courts.
12. Service Engagement Scale (SES; Tait et al, 2002): 14-item clinician-rated measure consisting of statements that assess client engagement with services. The scale has high internal consistency and retest reliability, including discrimination between criterion groups, in an assertive outreach team (Tait et al, 2002).
13. Client Satisfaction Questionnaire (CSQ; Larsen et al., 1979): 8-item self-report statement of satisfaction with health services. This will be collected at 12 months only.
14. Suicidal Behaviours Questionnaire–Revised (SBQ–R; Osman et al., 2001): brief 4-item self-report measure of suicidal behaviour and past attempts.
15. Self Harm Inventory (SHI; Sansone, 1998): 22-item, yes/no, self-report questionnaire used to assess self harm and suicidal behaviour.

A subsample of the participants (50%) will also have the oppertunity to complete the following measures:
1. Reflective Functioning Questionnaire-54 (RFQ54; Luyten, under development): 54-item self-report scale to measure mentalization capacities with regards to self and others.
2. Movie for the Assessment of Social Cognition (MASC) is a sensitive video-based test for the evaluation of subtle mind reading difficulties.
3. Social Hierarchy game is interpersonal exchange game in which two players make decisions that determine which player has control of a monetary endowment and one which has no control of monetary endowments across a series of interactions. The paradigm tests how participants evaluate the benefits and costs of aggressive actions, as they learn, develop, and update expectations of social partners.
4. InvestorTrustee game (King Casas et al., 2008) is an interpersonal exchange game in which a player makes a series of decisions to either trust or repay trust in a social partner.

Randomised controlled trial:
Unless otherwise stated, the secondary outcome measures are collected at baseline and every 6 months post randomisation.
1. Violent behaviour is measured using the MacArthur Community Violence Screening Instrument (MCVSI) at baseline and every 3 months post randomisation until 24 months.
2. Health outcomes are measured using the Euroqol5 (EQ5D)
3. Psychological symptom patters are measured using the Symptom Checklist-90 Revised (SCL-90-R)
4. Alcohol use is measured using the Alcohol Use Disorders Identification Test (AUDIT)
5. Illegal drug use is measured using the Drug Use Disorders Identification Test (DUDIT)
6. Self-harm behaviours are measured using the Self-Harm Inventory (SHI)
7. Suicidal Behaviours are measured using the Suicidal Behaviours Questionnaire–Revised (SBQ-R)
8. Levels of service engagement is measured using the Service Engagement Scale (SES)
9. Individual level service use is measured using the Secure Facilities Service Use Schedule (SF-SUS)
10. Psychological Personality traits are measured using the Personality Inventory for DSM-5 Brief Form (PID-5-BF)
11. Mentalization capacities with regards to self and others is measured using the Brief reflective function Questionnaire (B-RFQ)

Overall trial start date

01/01/2016

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Subject to statutory provision by the National Probation Service
2. Male aged 21 or over
3. At least 6 months remaining of their license or community sentence
4. Adequate level of English
5. Evidence of a history of violent behavior, that may include:
5.1. Verbal assault
5.2. Assaults against objects
5.3. Assault against others
6. DSM-IV-R diagnosis of ASPD (using SCID-II)
7. Evidence of recent aggressive acts (using OAS-M)

Participant type

Other

Age group

Adult

Gender

Male

Target number of participants

302

Participant exclusion criteria

1. Conviction for child sexual offences (including child pornography)
2. Current diagnosis for schizophrenia or bipolar disorder
3. Neurodevelopmental disorder or significant cognitive impairment
4. Severe substance or alcohol dependency

Recruitment start date

01/03/2016

Recruitment end date

30/05/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Westminster Probation Office (pilot and RCT)
1 Dorset Close
London
NW1 5AN
United Kingdom

Trial participating centre

Mersey Forensic Psychology Services (pilot and RCT)
36 Rodney Street
Liverpool
L1 9AA
United Kingdom

Trial participating centre

The Lincolnshire & North Yorkshire Probation Service (pilot and RCT)
8 Corporation Street
Lincoln
LN2 1HN
United Kingdom

Trial participating centre

Southwark probation (pilot and RCT)
2 Great Dover Street
London
SE1 4XW
United Kingdom

Trial participating centre

Llanelli Probation Service (RCT only)
Lloyd Street
Llanelli
SA15 2PU
United Kingdom

Trial participating centre

Exeter National Probation Service (RCT only)
Queens House Little Queen Street
Exeter
EX4 3LJ
United Kingdom

Trial participating centre

Tamworth Probation Office (RCT only)
Moor Street
Tamworth
B79 7QZ
United Kingdom

Trial participating centre

Lancashire Probation Trust (RCT only)
50 Avenham Street
Preston
PR1 3TD
United Kingdom

Trial participating centre

Bristol Central National Probation Service Office (RCT only)
Marlborough Street Avon
Bristol
BS1 3NU
United Kingdom

Trial participating centre

West Yorkshire Probation (RCT only)
Waterloo House 58 Wellington Street
Leeds
LS1 2EE
United Kingdom

Trial participating centre

Castle Quay probation (RCT only)
9 Castle Quay Castle Boulevard
Nottingham
NG7 1FW
United Kingdom

Trial participating centre

Stoke Newington Probation Service (RCT only)
Reed House 2-4 Rectory Road Stoke Newington
London
N16 7QS
United Kingdom

Trial participating centre

Lewisham Probation Office (RCT only)
208 Lewisham High Street
London
SE13 6JP
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office
University College London
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

Research organisation

Website

http://www.ucl.ac.uk/jro

Funders

Funder type

Charity

Funder name

The Michael J Samuel Charitable Trust (charity number: 327013)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/04/2016: The trial record has undergone a substantial update to include the full-scale randomised controlled trial. The study dates have been updated to reflect the full randomised controlled trial, but the pilot study dates are 01/06/2014 to 01/03/2018 (recruiting 01/04/2015 - 01/04/2016). The study aims, outcome measures, interventions and trial participating centres fields have been updated to reflect both studies.