Psychological treatments for severe and complex mental health problems/personality disorder. A phase II randomised controlled trial

ISRCTN	ISRCTN72677277
DOI	https://doi.org/10.1186/ISRCTN72677277
Secondary identifying numbers	ZC56

Submission date: 26/05/2005
Registration date: 29/07/2005
Last edited: 15/03/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Glenys Parry
Scientific

Mental Health Section
The School of Health and Related Research (ScHARR)
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 2220817
Email	G.D.Parry@sheffield.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Psychological treatments for severe and complex mental health problems/personality disorder. A phase II randomised controlled trial
Study acronym	SPeDi (Sheffield Personality Disorders)
Study objectives	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(s)	North Sheffield Ethics Office, 17/01/05, ref: 04/Q2308/80
Health condition(s) or problem(s) studied	Personality disorders
Intervention	CMHT management alone versus CMHT management plus cognitively-based psychotherapy.
Intervention type	Other
Primary outcome measure	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 study start date	01/05/2005
Completion date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	220
Key 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
Key exclusion criteria	Current in-patient, actively psychotic, primary drug/alcohol abuse.
Date of first enrolment	01/05/2005
Date of final enrolment	31/10/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Mental Health Section

Sheffield
S1 4DA
United Kingdom

Sponsor information

Sheffield Health and Social Research Consortium (UK)
Government

Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

15/03/2017: No publications found in PubMed, verifying study status with principal investigator.