Borderline Personality Disorder (BPD)NCT04033835
Mentalization Based Treatment - Introductory (MBT-I) Group for Male Prisoners With Borderline and/or Antisocial Personality Disorder
A study testing Mentalization Based Treatment-Introductory and Treatment as usual in people with Borderline Personality Disorder (BPD) and Antisocial Personality Disorder (ASPD), run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Borderline Personality Disorder (BPD), Antisocial Personality Disorder (ASPD)
- What is being tested?
- Mentalization Based Treatment-Introductory and Treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2019to 1 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of BPD and/or ASPD
- Co-morbidity with other personality disorder is accepted
- Sentenced prisoners with estimated date of liberation > six months
Who cannot join
- 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
Show all 9Show fewer
- Care in segregation and reintegration unit in past 3 months
- Current individual specialist psychological therapy in prison
- English as not first language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mentalization Based Treatment - Introductory Group for Male Prisoners With Borderline and/or Antisocial Personality Disorder in Her Majesty's Prison Barlinnie
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.
- Being tested
- Mentalization Based Treatment-Introductory, Treatment as usual
- Medical subject headings
- Borderline Personality Disorder, Antisocial Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mentalization Based Treatment-IntroductoryOther
Mentalization Based Treatment-Introductory
Treatment as usualOther
Treatment as usual
| Study group | Role | What they receive |
|---|---|---|
| MBT-I | Experimental | 12 sessions of MBT Receives: Other: Mentalization Based Treatment-Introductory |
| Waiting list control | Active comparator | Treatment as usual Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033835
- Sponsor's protocol ID
- GN19MH314
- Status last verified
- Jul 2019
- First submitted
- 10 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mentalization Based Treatment - Introductory Group for Male Prisoners With Borderline and/or Antisocial Personality Disorder in Her Majesty's Prison Barlinnie
- ClinicalTrials.gov ID
- NCT04033835
- Acronym / sponsor ID
- GN19MH314
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 26 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBT-I | Experimental | Other: Mentalization Based Treatment-Introductory12 sessions of MBT |
| Waiting list control | Active comparator | Other: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of BPD and/or ASPD
- Co-morbidity with other personality disorder is accepted
- Sentenced prisoners with estimated date of liberation > six months
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mentalization Based Treatment-IntroductoryMentalization Based Treatment-Introductory | Other | MBT-I |
| Treatment as usualTreatment as usual | Other | Waiting list control |
Primary outcome
Completion of three 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.
17 secondary outcomes
Quantitative data measuring change in difficulties with interpersonal relationships pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in difficulties with interpersonal relationships pre- and post-control
Time frame: 21 months
Quantitative data measuring change in difficulties with impulsivity pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in difficulties with impulsivity pre- and post-control
Time frame: 21 months
Quantitative data measuring change in difficulties with reflective functioning pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in difficulties with reflective functioning pre- and post-control
Time frame: 21 months
Quantitative data measuring change in depressive symptoms pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in depressive symptoms pre- and post-control
Time frame: 21 months
Quantitative data measuring change in anxiety symptoms pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in anxiety symptoms pre- and post-control
Time frame: 21 months
Quantitative data measuring change in social functioning and satisfaction pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in social functioning and satisfaction pre- and post-control
Time frame: 21 months
Quantitative data measuring change in overall symptoms and functioning pre- and post-intervention
Time frame: 21 months
Quantitative data measuring change in overall symptoms and functioning pre- and post-control
Time frame: 21 months
Quantitative data from behavioural proxy measures examining change in the number of challenging behaviours pre- and post-intervention
Time frame: 21 months
Quantitative data from behavioural proxy measures examining change in the number of challenging behaviours pre- and post-control
Time frame: 21 months
Qualitative data from follow up interviews of participants examining understanding of and overall satisfaction of intervention
Time frame: 21 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalization Based Treatment-Introductory and Treatment as usual in people with Borderline Personality Disorder (BPD) and Antisocial Personality Disorder (ASPD), run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephen Davidson, MBChB, MRCPsych (0141 201 6400, s.davidson7@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of three MBT-I group cycles (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.