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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Stephen Davidson, MBChB, MRCPsych contact

0141 201 6400

s.davidson7@nhs.net

United Kingdom1 site
  • NHS Greater Glasgow and Clyde

    Glasgow

Other trials in United Kingdom

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 groups in NCT04033835
Study groupRoleWhat they receive
MBT-IExperimental12 sessions of MBT
Receives: Other: Mentalization Based Treatment-Introductory
Waiting list controlActive comparatorTreatment as usual
Receives: Other: Treatment as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  1. First posted26 Jul 2019
  2. Study start1 Aug 2019 (estimated)
  3. Primary completion1 Aug 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Resources

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)
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

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.

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