Mentalization-based therapy (MBT) for individuals with antisocial personality disorder
| ISRCTN | ISRCTN32309003 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32309003 |
| Protocol serial number | Version 3 |
| Sponsor | University College London |
| Funders | The Michael J Samuel Charitable Trust (charity number: 327013), National Institute for Health Research |
- Submission date
- 18/02/2015
- Registration date
- 24/03/2015
- Last edited
- 23/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Research Department of Clinical, Educational & Health Psychology
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
Scientific
Research Department of Clinical, Educational & Health Psychology
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot study: Multi-centre pilot two-arm randomized controlled trial Randomised controlled trial: Multi-centre three phase pragmatic randomised controlled superiority trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Mentalization for Offending Adult Males: A National Randomised Controlled Trial (MOAM) |
| Study acronym | MOAM |
| Study objectives | 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(s) | 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: Approved 09/01/2015, NRES Committee London- South East (Bristol Research Ethics Committee Centre, Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44(0)1173421382; nrescommittee.london-southeast@nhs.net), ref: 14/LO/1696 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Pilot study and randomised controlled trial: |
| Key secondary outcome measure(s) |
Pilot study: |
| Completion date | 31/12/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 302 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/03/2016 |
| Date of final enrolment | 30/05/2018 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
London
NW1 5AN
United Kingdom
Liverpool
L1 9AA
United Kingdom
Lincoln
LN2 1HN
United Kingdom
London
SE1 4XW
United Kingdom
Llanelli
SA15 2PU
United Kingdom
Exeter
EX4 3LJ
United Kingdom
Tamworth
B79 7QZ
United Kingdom
Preston
PR1 3TD
United Kingdom
Avon
Bristol
BS1 3NU
United Kingdom
58 Wellington Street
Leeds
LS1 2EE
United Kingdom
Castle Boulevard
Nottingham
NG7 1FW
United Kingdom
2-4 Rectory Road
Stoke Newington
London
N16 7QS
United Kingdom
London
SE13 6JP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/03/2025 | 23/04/2025 | Yes | No | |
| Protocol article | 07/12/2020 | 04/04/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/04/2025: Publication reference added.
04/04/2023: Publication reference added.
22/07/2020: The following changes were made to the trial record:
1. The ethics approval was added for the randomised controlled trial.
2. The publication and dissemination plan was added.
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.