- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207970
Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder
January 26, 2021 updated by: Andrew White, Camden and Islington NHS Trust
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, N19 5NX
- Camden and Islington Personality Disorder Service
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adults with a diagnosis of Personality Disorder, under the care of Camden and Islington PDS.
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- No existing notes for one year prior to allocation.
- No primary diagnosis of Personality Disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Clients under PDS Community Team
27 adult clients under PDS Community Team
|
Adapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proxy measures of client distress
Time Frame: One year pre-referral and one year post-allocation
|
Inpatient admissions, safeguarding concerns, crisis centre contacts, crisis house admissions, criminal justice contacts.
|
One year pre-referral and one year post-allocation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Andrew White, Camden and Islington NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2019
Primary Completion (Actual)
June 1, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
December 19, 2019
First Submitted That Met QC Criteria
December 19, 2019
First Posted (Actual)
December 23, 2019
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 26, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 262702
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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