Condition category
Mental and Behavioural Disorders
Date applied
26/05/2005
Date assigned
29/07/2005
Last edited
20/05/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Glenys Parry

ORCID ID

Contact details

Mental Health Section
The School of Health and Related Research (ScHARR)
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 2220817
G.D.Parry@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZC56

Study information

Scientific title

Acronym

SPeDi (Sheffield Personality Disorders)

Study hypothesis

For patients with Cluster B personality disorders (as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV], Axis II), enhanced community mental health team (CMHT) management plus a cognitively-based psychotherapy is a more effective treatment than routine CMHT management alone. (The psychotherapies being used are Cognitive Analytic Therapy [CAT] and Cognitive Behavioural Therapy [CBT].)

Ethics approval

North Sheffield Ethics Office on 17/01/05 (ref: 04/Q2308/80)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Personality disorders

Intervention

CMHT management alone versus CMHT management plus cognitively-based psychotherapy.

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

The Risk subscale of the CORE tool (Clinical Outcomes in Routine Evaluation)

Secondary outcome measures

Health Status Questionnaire (SF36), Borderline Personality Disorder Checklist (BPD-CL), incidents of self-harm (Acts of Deliberate Self-Harm Inventory, ADSHI), economic cost of service use.

Overall trial start date

01/05/2005

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult out-patients (18-65) of community mental health teams (CMHTs).
2. Minimum one year history of severe, complex mental health problems, diagnosis of at least one Cluster B personality disorder.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant exclusion criteria

Current in-patient, actively psychotic, primary drug/alcohol abuse.

Recruitment start date

01/05/2005

Recruitment end date

31/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mental Health Section
Sheffield
S1 4DA
United Kingdom

Sponsor information

Organisation

Sheffield Health and Social Research Consortium (UK)

Sponsor details

Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

University/education

Funder name

University of Sheffield, Sheffield Health and Social Research Consortium (ref ZC56) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes