NCT04033835

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

July 26, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 10, 2019

Last Update Submit

July 23, 2019

Conditions

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

Outcome Measures

Primary Outcomes (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.

    18 months

Secondary Outcomes (17)

  • Quantitative data measuring change in difficulties with interpersonal relationships pre- and post-intervention

    21 months

  • Quantitative data measuring change in difficulties with interpersonal relationships pre- and post-control

    21 months

  • Quantitative data measuring change in difficulties with impulsivity pre- and post-intervention

    21 months

  • Quantitative data measuring change in difficulties with impulsivity pre- and post-control

    21 months

  • Quantitative data measuring change in difficulties with reflective functioning pre- and post-intervention

    21 months

  • +12 more secondary outcomes

Study Arms (2)

MBT-I

EXPERIMENTAL

12 sessions of MBT

Other: Mentalization Based Treatment-Introductory

Waiting list control

ACTIVE COMPARATOR

Treatment as usual

Other: Treatment as usual

Interventions

Mentalization Based Treatment-IntroductoryOTHER

Mentalization Based Treatment-Introductory

MBT-I
Treatment as usualOTHER

Treatment as usual

Waiting list control

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of BPD and/or ASPD
  • Co-morbidity with other personality disorder is accepted
  • Sentenced prisoners with estimated date of liberation \> six months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Borderline Personality DisorderAntisocial Personality Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Central Study Contacts

Stephen Davidson, MBChB, MRCPsych

CONTACT

0141 201 6400s.davidson7@nhs.net

Erica Packard, PhD

CONTACT

0141 287 0384erica.packard@ggc.scot.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2019

First Posted

July 26, 2019

Study Start

August 1, 2019

Primary Completion

August 1, 2021

Study Completion

August 1, 2021

Last Updated

July 26, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)