Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.
Anna Freud National Centre for Children and Families, London, UK.
Trials. 2020 Dec 7;21(1):1001. doi: 10.1186/s13063-020-04896-w.
Antisocial personality disorder (ASPD), although associated with very significant health and social burden, is an under-researched mental disorder for which clinically effective and cost-effective treatment methods are urgently needed. No intervention has been established for prevention or as the treatment of choice for this disorder. Mentalization-based treatment (MBT) is a psychotherapeutic treatment that has shown some promising preliminary results for reducing personality disorder symptomatology by specifically targeting the ability to recognize and understand the mental states of oneself and others, an ability that is compromised in people with ASPD. This paper describes the protocol of a multi-site RCT designed to test the effectiveness and cost-effectiveness of MBT for reducing aggression and alleviating the wider symptoms of ASPD in male offenders subject to probation supervision who fulfil diagnostic criteria for ASPD.
Three hundred and two participants recruited from a pool of offenders subject to statutory supervision by the National Probation Service at 13 sites across the UK will be randomized on a 1:1 basis to 12 months of probation plus MBT or standard probation as usual, with follow-up to 24 months post-randomization. The primary outcome is frequency of aggressive antisocial behaviour as assessed by the Overt Aggression Scale - Modified. Secondary outcomes include violence, offending rates, alcohol use, drug use, mental health status, quality of life, and total service use costs. Data will be gathered from police and criminal justice databases, NHS record linkage, and interviews and self-report measures administered to participants. Primary analysis will be on an intent-to-treat basis; per-protocol analysis will be undertaken as secondary analysis. The primary outcome will be analysed using hierarchical mixed-effects linear regression. Secondary outcomes will be analysed using mixed-effects linear regression, mixed-effects logistic regression, and mixed-effects Poisson models for secondary outcomes depending on whether the outcome is continuous, binary, or count data. A cost-effectiveness and cost-utility analysis will be undertaken.
This definitive, national, multi-site trial is of sufficient size to evaluate MBT to inform policymakers, service commissioners, clinicians, and service users about its potential to treat offenders with ASPD and the likely impact on the population at risk.
ISRCTN 32309003 . Registered on 8 April 2016.
反社会型人格障碍（ASPD）虽然与非常显著的健康和社会负担有关，但作为一种研究不足的精神障碍，迫切需要临床有效且具有成本效益的治疗方法。目前还没有针对这种疾病的预防或首选治疗方法。基于心理化的治疗（MBT）是一种心理治疗方法，它通过专门针对识别和理解自己和他人心理状态的能力，已经显示出一些有希望的初步结果，这种能力在 ASPD 患者中受到损害。本文描述了一项多地点 RCT 的方案，旨在测试 MBT 对减少攻击性和缓解接受法定监督的男性罪犯的更广泛的 ASPD 症状的有效性和成本效益，这些罪犯符合 ASPD 的诊断标准。
从英国 13 个地点的国家缓刑服务机构中招募的 302 名符合条件的罪犯将以 1:1 的比例随机分配到 12 个月的缓刑加 MBT 或标准缓刑，随访至随机分组后 24 个月。主要结局是通过修改后的显性攻击量表评估的攻击性反社会行为的频率。次要结局包括暴力、犯罪率、酒精使用、药物使用、心理健康状况、生活质量和总服务使用成本。数据将从警察和刑事司法数据库、NHS 记录链接以及对参与者的访谈和自我报告措施中收集。主要分析将基于意向治疗原则；次要分析将采用方案分析。主要结局将使用分层混合效应线性回归进行分析。次要结局将根据结局是连续的、二分类的还是计数数据，使用混合效应线性回归、混合效应逻辑回归和混合效应泊松模型进行分析。将进行成本效益和成本效用分析。
这项具有足够规模的全国性多地点试验旨在评估 MBT，为决策者、服务专员、临床医生和服务使用者提供信息，了解其治疗 ASPD 罪犯的潜力及其对风险人群的可能影响。
ISRCTN32309003。于 2016 年 4 月 8 日注册。
