| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN66542253 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0560180008 |
| Public title | Comparison of three forms of self help cognitive behavioural therapy |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders: Depression |
| Study hypothesis | To implement and compare the impact of three cognitive behavioural therapies: Beating the Blues, workbook and internet based. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients aged 18+ years old
2. Suffering from depression, mixed anxiety and depression or anxiety disorder
3. Not receiving any form of psychological treatment or counselling |
| Participants - exclusion criteria | 1. Active suicidal ideas
2. A current or lifetime diagnosis of psychosis, personality disorder or organic mental disorder
3. Alcohol and/or drug dependence
4. Have taken medication for anxiety and /or depression continuously for 6 months or more immediately prior to entry |
| Patient information material |
|
| Anticipated start date | 01/06/2006 |
| Anticipated end date | 01/12/2007 |
| Status of trial | Completed |
| Target number of participants | 180 referrals to the research although not all have completed the treatment and followup protocol. |
| Interventions | A co-ordinator will establish proactive links with GPs in the area, organize data collection for the research, assess the need for an interpreter to facilitate sessions, and oversee the use of computers by clients GPs will refer patients if they meet certain criteria. Interested individuals will be asked to give signed consent and then complete a baseline CORE assessment before being randomly allocated to one of the three self-help tools. |
| Primary outcome measure(s) | 1. Differences in the following indicators of mental health and use of services: total antidepressants dispensed during the 6 months following the diagnosis
2. Use of counselling or other secondary mental health services in the 6 months following the diagnosis
3. Programme completed or interrupted
4. Consultations with primary care staff over the 6 months follow up period
5. Consultations with secondary care over the 6 months follow up period
5. CORE assessment scores at 6 weeks. |
| Secondary outcome measure(s) | At six months the following data items will be recorded for all patients:
1. Consultations with primary care staff over the 6 months follow up period
2. Total antidepressants dispensed during the 6 months following the diagnosis (information gathered from the GP's computer)
3. Use of counselling or other secondary mental health services in the 6 months following the diagnosis and referral to the service (information gathered from the local counseling service and Oxleas mental health Trust)
4. Programme completed or interrupted
CORE assessment scores at 8 weeks |
| Sources of funding | Bexley Care Trust
|
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Hannah Patrick |
| Contact details | Bexley Care Trust
221 Erith Road
Bexleyheath
United Kingdom
DA7 6HZ |
| Contact telephone | +44 020 8298 6210 |
| Contact fax | +44 020 8298 6049 |
| Contact email | Hannah.patrick@bexley.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN66542253 |
| Date last extracted from ISRCTN register | 17/04/2008 |
