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

Borderline Personality Disorder (BPD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04033835
• Other study ID #: GN19MH314
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: August 1, 2021

Study information

• Verified date: July 2019
• Source: NHS Greater Glasgow and Clyde
• Contact: Stephen Davidson, MBChB, MRCPsych
• Phone: 0141 201 6400
• Email: s.davidson7[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antisocial Personality Disorder
• Antisocial Personality Disorder (ASPD)
• Borderline Personality Disorder
• Borderline Personality Disorder (BPD)
• Disease
• Personality Disorders

Intervention

Other:
• Mentalization Based Treatment-Introductory
Mentalization Based Treatment-Introductory
• Treatment as usual
Treatment as usual

Locations

Country	Name	City	State
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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