Contact information
Type
Scientific
Contact name
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/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
ZC56
Study information
Scientific title
Psychological treatments for severe and complex mental health problems/personality disorder. A phase II randomised controlled trial
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(s)
North Sheffield Ethics Office, 17/01/05, ref: 04/Q2308/80
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Treatment
Patient information sheet
Condition
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
Overall study end date
31/10/2007
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Upper age limit
65 Years
Sex
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
England, United Kingdom
Study participating centre
Mental Health Section
Sheffield
S1 4DA
United Kingdom
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|