Personality DisordersNCT04207970
Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder
An observational study of Personality Disorders, run by Camden and Islington NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Personality Disorders
- What is being tested?
- Adapted Structured Clinical Management
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Dec 2019to 31 Aug 2020
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a diagnosis of Personality Disorder, under the care of Camden and Islington PDS.
Who may be able to join
- 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).
Who cannot join
- No existing notes for one year prior to allocation.
- No primary diagnosis of Personality Disorder.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Camden and Islington Personality Disorder Service
London, N19 5NX
About this study
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.
- Conditions
- Personality Disorders
- Being tested
- Adapted Structured Clinical Management
- Medical subject headings
- Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Structured Clinical ManagementOther
Adapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners.
| Study group | Role | What they receive |
|---|---|---|
| Clients under PDS Community Team | 27 adult clients under PDS Community Team Receives: Other: Adapted Structured Clinical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proxy measures of client distress
Inpatient admissions, safeguarding concerns, crisis centre contacts, crisis house admissions, criminal justice contacts.
Measured: One year pre-referral and one year post-allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start19 Dec 2019
- Primary completion1 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personality DisordersStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camden and Islington NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Andrew White, Camden and Islington NHS Trust
- Investigators
- Andrew White, Principal investigator, Camden and Islington NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207970
- Sponsor's protocol ID
- 262702
- Status last verified
- Jan 2021
- First submitted
- 19 Dec 2019
- Last updated
- 28 Jan 2021
- Results posted
- 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder
- ClinicalTrials.gov ID
- NCT04207970
- Acronym / sponsor ID
- 262702
- Conditions
- Personality Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Camden and Islington NHS TrustOther government
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 23 Dec 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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clients under PDS Community Team | – | Other: Adapted Structured Clinical Management27 adult clients under PDS Community Team |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a diagnosis of Personality Disorder, under the care of Camden and Islington PDS.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (2 listed)
- No existing notes for one year prior to allocation.
- No primary diagnosis of Personality Disorder.
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 |
|---|---|---|
| Adapted Structured Clinical ManagementAdapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners. | Other | Clients under PDS Community Team |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- 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.
Andrew White principal investigator
Camden and Islington NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Personality Disorders, run by Camden and Islington NHS Trust 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proxy measures of client distress (time frame: One year pre-referral and one year post-allocation). 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 28 Jan 2021.