. 2020 Sep 3;2020(9):CD007668. doi: 10.1002/14651858.CD007668.pub3

NCT04033835.

Study name	Mentalisation Based Treatment ‐ Introductory group for male prisoners with borderline and/or antisocial personality disorder in Her Majesty's Prison Barlinnie
Methods	Design:Open label, cross‐over, randomised clinical trial
Participants	Participants: Male sentenced prisoners with primary diagnosis of borderline PD and/or anti‐social PD Age:18 years and older Unit of allocation: individual Target sample size: 30 participants Inclusion criteria: primary diagnosis of BPD and/or AsPD; comorbidity with other personality disorder is accepted; sentenced prisoners with estimated date of liberation > six months Exclusion criteria: comorbid severe and enduring mental illness (schizophrenia, delusional disorder, bipolar affective disorder, major depressive disorder); comorbid organic brain disorder (acquired brain injury, alcohol‐related brain damage); remand prisoners; uncontrolled substance dependence; index offence of sexual offending; repeatedly chaotic, antisocial or violent behaviour in prison; care in segregation and reintegration unit in past 3 months; current individual specialist psychological therapy in prison; English as not first language
Interventions	Two conditions: Mentalisation‐Based Treatment‐Introductory (MBT‐I); or waiting‐list control/treatment‐as‐usual Experimental group: MBT‐I Control group: TAU (waiting‐list control) Details of conditions: MBT‐I is not described in the clinical trials record; completion of the intervention is described as attending three cycles of group MBT‐I (each cycle of MBT‐I has 12 sessions). TAU is not described in the clinical trials record. Duration of intervention: 18 months Duration of trial: 21 months Length of follow‐up: 3 months post‐intervention
Outcomes	Primary outcomes of trial Completion of 3 MBT‐I group cycles [time frame = 18 months] Participants to have attended ≥ 75% (9 or more out of 12) of scheduled sessions to consider this successful completion of the programme ≥ 50% participants who commenced session one to have completed the intervention as described above to consider the group successful Secondary outcomes of trial (time frame for all secondary outcomes is 21 months; measures administered one week pre‐, one week post‐ and three months post‐intervention) Interpersonal functioning: change in interpersonal functioning using Inventory of Interpersonal Problems‐32, pre‐ and post‐intervention Impulsivity: change in impulsivity using Barrett Impulsiveness Scale (BIS) pre‐ and post‐intervention Mental state: change in difficulties with reflective functioning using Reflective Functioning Questionnaire (RFQ) pre‐ and post‐intervention Mental state: change in depressive symptoms using Beck's Depression Inventory (BDI) pre‐ and post‐intervention Mental state: change in anxiety symptoms using Beck's Anxiety Inventory (BAI) pre‐ and post‐intervention Social functioning: change in social functioning and satisfaction using Social Adjustment Scale‐Self Report (SAS‐SR) pre‐ and post‐intervention Global functioning: quantitative data measuring change in overall symptoms and functioning using Clinical Outcomes in Routine Evaluation‐Outcome Measure (CORE‐OM) pre‐ and post‐intervention Challenging behaviour: quantitative data from behavioural proxy measures examining change in the number of challenging behaviours pre‐ and post‐intervention [time frame = 21 months]; number of discipline procedures (reports) and Incentives and Enhanced Privileges (IEPs) will be examined over a 3‐month period pre‐intervention, 3‐month period during the intervention and 3‐month period post‐intervention to allow a behavioural proxy measure of negative (reports) vs positive (IEPs) behaviours Satisfaction with treatment: qualitative data from follow‐up interviews examining understanding of and overall satisfaction of intervention; semi‐structured interview schedule to be completed 1 week post‐ and 3 months post‐intervention; examines participants' understanding of the concepts of the intervention, in addition to their overall satisfaction Other outcomes of trial none
Starting date	1 August 2019^a; estimated completion date 1 August 2021
Contact information	Stephen Davidson (s.davidson7@nhs.net) Erica Packard (erica.packard@ggc.scot.nhs.uk) NHS Greater Glasgow and Clyde, Glasgow, United Kingdom
Notes	^aThe last update on the clinical trials site [26 July 2019] stated that the study is not yet recruiting.

^{AsPD = antisocial personality disorder} ^{ASUS = Adult Service Use Schedule} ^{AUDIT = Alcohol Use Disorders Identification Test} ^{BAI = Beck Anxiety Inventory} ^{BDI = Beck Depression Inventory} ^{BIS = Barratt Impulsiveness Scale} ^{BPD = borderline personality disorder} ^{BSI (‐53) = Brief Symptom Inventory} ^{CGI = Clinical Global Impression} ^{CORE‐OM = Clinical Outcomes in Routine Evaluation–Outcome Measure} ^{CSQ = Client Satisfaction Questionnaire} ^{CTR = Clinical Trial Register} ^{DSM‐IV‐R = Diagnostic and Statistical Manual of Mental Disorders‐Fourth Edition‐Revised}  ^{DUDIT = Drug Use Disorders Identification Test} ^{EQ‐5D (‐5L) = EuroQol 5 dimensions, 5 levels instrument} ^{HTA = Health Technology Assessment} ^{IEP = incentives and enhanced privileges} ^{MAIA = Multidimensional Assessment of Interoceptive Awareness} ^{MASC = Movie for the Assessment of Social Cognition} ^{MBT (‐I) = mentalization based treatment‐introductory} ^{MCVSI = MacArthur Community Violence Screening Instrument} ^{MIH RRTP = mental health residential rehabilitation treatment programme} ^{MoCA = Montreal Cognitive Assessment} ^{MRI = magnetic resonance imaging} ^{MRT = moral reconation therapy} ^{NHSPM = National Household Survey of Psychiatric Morbidity} ^{OAS‐M = Overt Aggression Scale‐Modified} ^{PAU = probation as usual} ^{PCL‐R = Psychopathy Checklist‐Revised} ^{PD = personality disorder} ^{PMT = psychomotor therapy} ^{PPI‐R = Psychopathic Personality Inventory‐Revised} ^{PSP = psychological support for personality} ^{RFQ(54) = Reflective Functioning Questionnaire‐54} ^{SAS‐SR = Social Adjustment Scale‐Self‐Report} ^{SBQ‐R = Suicidal Behaviours Questionnaire–Revised} ^{SCID‐5‐PD (‐11) = Structured Clinical Interview for DSM‐5 [}^{DSM‐5 = Diagnostic and Statistical Manual of Mental Disorders‐Fifth Edition] for Personality Disorders} ^{SES = Service Engagement Scale} ^{SFQ = Social Functioning Questionnaire} ^{SFSUS = Secure Facilities Service Use Schedule} ^{SFT = schema‐focussed therapy} ^{SHI = Self Harm Inventory} ^{SIPP‐SF = Severity Indices of Personality Problems–Short Form} ^{STAXI 2 = State Trait Anger Expression Inventory 2} ^{TAU = treatment as usual} ^{UC = usual care} ^{vs = versus} ^{WEMWBS = Warwick‐Edinburgh Mental Wellbeing Scale} ^{WSAS = Work and Social Adjustment Scale}