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 |
| Protocol serial number | ZC56 |
| Sponsor | Sheffield Health and Social Research Consortium (UK) |
| Funder | University of Sheffield, Sheffield Health and Social Research Consortium (ref ZC56) (UK) |
- 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
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 |
|---|---|
| G.D.Parry@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
The Risk subscale of the CORE tool (Clinical Outcomes in Routine Evaluation) |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Mental Health Section
Sheffield
S1 4DA
United Kingdom
S1 4DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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.
