NCT04207970

Brief Summary

Camden and Islington NHS Foundation Trust in London has a Personality Disorder Service (PDS) which offers a number of evidence-based interventions to people with a diagnosis of Personality Disorder. One team in the PDS, the Community Team, offers an adapted form of Structured Clinical Management (SCM; Bateman and Kravitz, 2013). As these adaptations are novel, this study aims to formally explore the effectiveness of this intervention, through a sample of clients under the team, with outcomes (proxy measures of distress such as inpatient admissions) pre- and post- intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 19, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 19, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

December 19, 2019

Last Update Submit

January 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proxy measures of client distress

    Inpatient admissions, safeguarding concerns, crisis centre contacts, crisis house admissions, criminal justice contacts.

    One year pre-referral and one year post-allocation

Study Arms (1)

Clients under PDS Community Team

27 adult clients under PDS Community Team

Other: Adapted Structured Clinical Management

Interventions

Adapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners.

Clients under PDS Community Team

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults with a diagnosis of Personality Disorder, under the care of Camden and Islington PDS.

You may qualify if:

  • Allocated to a care coordinator at the PDS for greater than one year (a reasonable time period for therapeutic rapport to form and the effect of the intervention to manifest).

You may not qualify if:

  • No existing notes for one year prior to allocation.
  • No primary diagnosis of Personality Disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Camden and Islington Personality Disorder Service

London, N19 5NX, United Kingdom

Location

MeSH Terms

Conditions

Personality Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Andrew White

    Camden and Islington NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Psychologist

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 23, 2019

Study Start

December 19, 2019

Primary Completion

June 1, 2020

Study Completion

August 31, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations