Dialectical behaviour therapy in patients with borderline personality disorder who self-harm: a pragmatic exploratory trial
| ISRCTN | ISRCTN54233644 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54233644 |
| Secondary identifying numbers | PB-PG-0906-10540 |
- Submission date
- 30/07/2008
- Registration date
- 25/09/2008
- Last edited
- 23/07/2014
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Stefan Priebe
Scientific
Scientific
Unit for Community and Social Psychiatry
Newham Centre for Mental Health
Cherry Tree Way, Glen Road
Plaistow
London
E13 8SP
United Kingdom
| Phone | +44 (0)20 7540 4210 |
|---|---|
| s.priebe@qmul.ac.uk |
Study information
| Study design | Pilot randomised controlled pragmatic exploratory trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | DIALECT |
| Study objectives | Self-harming patients receiving a one-year course of dialectical behaviour therapy (DBT) will self-harm less over the 12 months than patients receiving one year of treatment as usual. |
| Ethics approval(s) | The Camden and Islington Community Local Research Ethics Committee, 18/02/2008, ref: 07/H0722/98 |
| Health condition(s) or problem(s) studied | Borderline personality disorder, self-harm |
| Intervention | DBT and care co-ordination versus waiting list control group with standard NHS care, over 12 months. DBT consists of 3 hours of therapy a week: this comprises 1 hour of individual therapy and 2 hours of group skills classes. |
| Intervention type | Other |
| Primary outcome measure | Days with self-harm during the 12-month period. |
| Secondary outcome measures | 1. Pre-post changes in self-harming during the 12-month period 2. Number of accident and emergency (A&E) attendances during the 12-month period 3. Inpatient admissions during the 12-month period 4. Use of other services in primary and secondary care during the 12-month period 5. Service costs during the 12-month period 6. Use of medication during the 12-month period 7. Pre-post changes in self-rated and observer-rated symptom level and quality of life at the end of the 12 month period 8. Quality of the therapeutic relationship at the end of the 12-month period 9. Treatment satisfaction at the end of the 12-month period |
| Overall study start date | 01/02/2008 |
| Completion date | 01/07/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 1. Frequent self-harm (more than 5 days with self-harm over 12 months) 2. Aged 16 years and older, either sex 3. Sufficient command of English 4. At least one personality disorder |
| Key exclusion criteria | Learning disabilities |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 01/07/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Unit for Community and Social Psychiatry
London
E13 8SP
United Kingdom
E13 8SP
United Kingdom
Sponsor information
East London NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Trust Headquarters
EastONE
22 Commercial Street
London
E1 6LP
England
United Kingdom
| Phone | +44 (0)20 7655 4000 |
|---|---|
| webadmin@eastlondon.nhs.uk | |
| Website | http://www.eastlondon.nhs.uk/ |
"ROR" |
https://ror.org/01q0vs094 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
