Mentalization Based Treatment - Introductory (MBT-I) Group for Male Prisoners With Borderline and/or Antisocial Personality Disorder

Study Overview
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Brief Summary
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Established evidence base with MBT for treatment of Borderline Personality Disorder (BPD) and/or Antisocial Personality Disorder (ASPD). Demographic information of United Kingdom prison population highlights large proportion of offenders with PD. There is no agreed universal approach to treatment of PD within Scottish prisons with large variance across the prison estate. MBT pilots in HMP Edinburgh and HMP Cornton Vale have demonstrated positive findings in female offenders which could be replicated in male populations.

Official Title
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Mentalization Based Treatment - Introductory Group for Male Prisoners With Borderline and/or Antisocial Personality Disorder in Her Majesty's Prison Barlinnie

Conditions
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Borderline Personality Disorder (BPD), Antisocial Personality Disorder (ASPD)

Intervention / Treatment
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* Other: Mentalization Based Treatment-Introductory
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of BPD and/or ASPD Co-morbidity with other personality disorder is accepted Sentenced prisoners with estimated date of liberation > six months Exclusion Criteria: Co-morbid severe and enduring mental illness (schizophrenia, delusional disorder, bipolar affective disorder, major depressive disorder) Co-morbid 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBT-I<br>12 sessions of MBT | Other: Mentalization Based Treatment-Introductory<br>* Mentalization Based Treatment-Introductory<br>|
| Active Comparator: Waiting list control<br>Treatment as usual | Other: Treatment as usual<br>* Treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of three MBT-I group cycles | 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative data measuring change in difficulties with interpersonal relationships pre- and post-intervention | Inventory of Interpersonal Problems-32 (IIP-32) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with interpersonal relationships which are a core feature of personality disorder psychopathology. There are 32 items scored on a 5 point scale (0-4) measuring 2 domains of affiliating and distancing (16 items each) difficulties with interpersonal relationships. There are 8 differing interpersonal relationship styles (4 each for affiliating and distancing). The maximum score therefore for each style is 16 (4 x 4 point scores), for each domain is 64 (16 x 4 point scores), and total score is 128 (32 x 4 point scores). The minimum score is 0. Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in difficulties with interpersonal relationships pre- and post-control | Inventory of Interpersonal Problems-32 (IIP-32) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with interpersonal relationships which are a core feature of personality disorder psychopathology. There are 32 items scored on a 5 point scale (0-4) measuring 2 domains of affiliating and distancing (16 items each) difficulties with interpersonal relationships. There are 8 differing interpersonal relationship styles (4 each for affiliating and distancing). The maximum score therefore for each style is 16 (4 x 4 point scores), for each domain is 64 (16 x 4 point scores), and total score is 128 (32 x 4 point scores). The minimum score is 0. Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in difficulties with impulsivity pre- and post-intervention | Barrett Impulsiveness Scale (BIS) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with impulsivity which is a core feature of personality disorder psychopathology. There are 30 items scored on a 4 point (1-4) scale measuring impulsivity. The maximum score is 120 (30 x 4 point scores). The minimum score is 30 (30 x 1 point scores). Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in difficulties with impulsivity pre- and post-control | Barrett Impulsiveness Scale (BIS) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with impulsivity which is a core feature of personality disorder psychopathology. There are 30 items scored on a 4 point (1-4) scale measuring impulsivity. The maximum score is 120 (30 x 4 point scores). The minimum score is 30 (30 x 1 point scores). Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in difficulties with reflective functioning pre- and post-intervention | Reflective Functioning Questionnaire (RFQ) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with reflective functioning which is a core feature of personality disorder psychopathology. There are 54 items scored on a 7 point (1-7) scale measuring 2 domains of certainty and uncertainty (26 items each) difficulties with reflective functioning. Two items do not score. Only extreme rankings score points for each item (i.e 7 or 1 scores 3, 6 or 2 scores 2 and 5 or 3 scores 1 depending on the item type). The maximum score therefore for each domain is 78 (26 x 3 point scores), and total score is 156 (52 x 3 point scores). The minimum score is 0. Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in difficulties with reflective functioning pre- and post-control | Reflective Functioning Questionnaire (RFQ) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with reflective functioning which is a core feature of personality disorder psychopathology. There are 54 items scored on a 7 point (1-7) scale measuring 2 domains of certainty and uncertainty (26 items each) difficulties with reflective functioning. Two items do not score. Only extreme rankings score points for each item (i.e 7 or 1 scores 3, 6 or 2 scores 2 and 5 or 3 scores 1 depending on the item type). The maximum score therefore for each domain is 78 (26 x 3 point scores), and total score is 156 (52 x 3 point scores). The minimum score is 0. Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in depressive symptoms pre- and post-intervention | Beck's Depression Inventory (BDI) to be administered one week pre-, one week post- and three months post-intervention. The scale measures depressive symptoms which are a common feature of personality disorder psychopathology. There are 21 items scored on a 4 point (0-3) scale measuring depressive symptoms. The maximum score is 63 (21 x 3 point scores). The minimum score is 0. Higher values indicate increasing severity (1-10 - these ups and downs are considered normal; 11-16 - mild mood disturbance; 17-20 - borderline clinical depression; 21-30 - moderate depression; 31-40 - severe depression; >40 - extreme depression). | 21 months | 
| Quantitative data measuring change in depressive symptoms pre- and post-control | Beck's Depression Inventory (BDI) to be administered one week pre-, one week post- and three months post-intervention. The scale measures depressive symptoms which are a common feature of personality disorder psychopathology. There are 21 items scored on a 4 point (0-3) scale measuring depressive symptoms. The maximum score is 63 (21 x 3 point scores). The minimum score is 0. Higher values indicate increasing severity (1-10 - these ups and downs are considered normal; 11-16 - mild mood disturbance; 17-20 - borderline clinical depression; 21-30 - moderate depression; 31-40 - severe depression; >40 - extreme depression). | 21 months | 
| Quantitative data measuring change in anxiety symptoms pre- and post-intervention | Beck's Anxiety Inventory (BAI) to be administered one week pre-, one week post- and three months post-intervention. The scale measures anxiety symptoms which are a common feature of personality disorder psychopathology. There are 21 items scored on a 4 point (0-3) scale measuring anxiety symptoms. The maximum score is 63 (21 x 3 point scores). The minimum score is 0. Higher values indicate increasing severity (0-21 - low anxiety; 22-35 - moderate anxiety; >35 - potentially concerning levels of anxiety). | 21 months | 
| Quantitative data measuring change in anxiety symptoms pre- and post-control | Beck's Anxiety Inventory (BAI) to be administered one week pre-, one week post- and three months post-intervention. The scale measures anxiety symptoms which are a common feature of personality disorder psychopathology. There are 21 items scored on a 4 point (0-3) scale measuring anxiety symptoms. The maximum score is 63 (21 x 3 point scores). The minimum score is 0. Higher values indicate increasing severity (0-21 - low anxiety; 22-35 - moderate anxiety; >35 - potentially concerning levels of anxiety). | 21 months | 
| Quantitative data measuring change in social functioning and satisfaction pre- and post-intervention | Social Adjustment Scale - Self Report (SAS-SR) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with social functioning and satisfaction which are common sequelae of personality disorder. There are 54 items scored measuring instrumental and expressive performance over the past two weeks. They examine across 6 domains - work, social and leisure, extended family, primary relationship, parental, family unit. Within these domains, the items cover 4 categories - performance, friction with people, finer aspects of interpersonal relations, and feelings and satisfactions. | 21 months | 
| Quantitative data measuring change in social functioning and satisfaction pre- and post-control | Social Adjustment Scale - Self Report (SAS-SR) to be administered one week pre-, one week post- and three months post-intervention. The scale measures difficulties with social functioning and satisfaction which are common sequelae of personality disorder. There are 54 items scored measuring instrumental and expressive performance over the past two weeks. They examine across 6 domains - work, social and leisure, extended family, primary relationship, parental, family unit. Within these domains, the items cover 4 categories - performance, friction with people, finer aspects of interpersonal relations, and feelings and satisfactions. | 21 months | 
| Quantitative data measuring change in overall symptoms and functioning pre- and post-intervention | Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) to be administered one week pre-, one week post- and three months post-intervention. The scale measures overall change in symptoms and functioning from baseline following completion of the intervention. There are 34 items scored on a 5 point (0-4) scale measuring overall change across 4 domains - subjective well-being (4 items), problems and symptoms (12 items), life functioning (12 items), and risk and harm (6 items). The maximum score is 136 (34 x 4 point scores). The minimum score is 0. Higher values indicate increasing severity. | 21 months | 
| Quantitative data measuring change in overall symptoms and functioning pre- and post-control | Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) to be administered one week pre-, one week post- and three months post-intervention. The scale measures overall change in symptoms and functioning from baseline following completion of the intervention. There are 34 items scored on a 5 point (0-4) scale measuring overall change across 4 domains - subjective well-being (4 items), problems and symptoms (12 items), life functioning (12 items), and risk and harm (6 items). The maximum score is 136 (34 x 4 point scores). The minimum score is 0. Higher values indicate increasing severity. | 21 months | 
| Quantitative data from behavioural proxy measures examining change in the number of challenging behaviours pre- and post-intervention | The number of discipline procedures (reports) and Incentives and Enhanced Privileges (IEPs) will be examined over a three month period pre-intervention, three month period during the intervention and three month period post-intervention. This allows a behavioural proxy measure of negative (reports) vs. positive (IEPs) behaviours. | 21 months | 
| Quantitative data from behavioural proxy measures examining change in the number of challenging behaviours pre- and post-control | The number of discipline procedures (reports) and Incentives and Enhanced Privileges (IEPs) will be examined over a three month period pre-intervention, three month period during the intervention and three month period post-intervention. This allows a behavioural proxy measure of negative (reports) vs. positive (IEPs) behaviours. | 21 months | 
| Qualitative data from follow up interviews of participants examining understanding of and overall satisfaction of intervention | Semi-structured interview schedule to be completed one week post- and three months post- intervention. This will examine participant's understanding of the concepts of the intervention, in addition to their overall satisfaction. | 21 months |