Evaluating Adapted Structured Clinical Management for Peo... | NCT04207970

Studies
Evaluating Adapted Structured Clinical Management for People With a Diagnosis of Personality Disorder

NCT04207970

Sponsor

Camden and Islington NHS Trust

Status

Completed

Last Update Posted

Jan 28, 2021Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Personality Disorders

Interventions

Adapted Structured Clinical Management

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2019Actual

Primary Completion Date

Jun 1, 2020Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Dec 19, 2019

First Submission Date that Met QC Criteria

Dec 19, 2019

First Posted Date

Dec 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2021

Last Update Posted Date

Jan 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrew White, Clinical Psychologist, Camden and Islington NHS TrustPrincipal Investigator

Lead Sponsor

Camden and Islington NHS TrustOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clients under PDS Community Team		27 adult clients under PDS Community Team	Other: Adapted Structured Clinical Management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adapted Structured Clinical Management	Other	Adapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew White	Camden and Islington NHS Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Camden and Islington Personality Disorder Service		London		N19 5NX	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided