| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN49123202 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0124183305 |
| Public title | A before and after study to investigate the effectiveness of an individual psychological intervention in reducing anxiety and depression for heart failure patients |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders: Anxiety disorders |
| Study hypothesis | Is psychological therapy for heart failure combined with normal care better than normal care by itself at reducing depression and anxiety, improving coping and helping patients to address a self-identified heart failure related issue and/or a nurse consultant identified heart failure related issue? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Heart failure patients scoring 8 or higher on the Hospital and Anxiety Scale, with an issue identified by the nurse consultant that could benefit from psychological input or identified by heart failure patients and discussed with the nurse consultant. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
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| Anticipated start date | 01/07/2006 |
| Anticipated end date | 01/07/2009 |
| Status of trial | Ongoing |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients will be randomised into either an immediate treatment or a waiting treatment group.
Patients in both groups will be asked to complete questionnaires at beginning of treatment, end of treatment and at 3 months follow-up. |
| Primary outcome measure(s) | Significant difference between groups in depression, anxiety, coping style, self-identified problem rating, nurse identified problem rating. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | University Hospital Lewisham NHS Trust
NHS R&D Support Funding |
| 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 | Mrs Annie O'Donoghue |
| Contact details | Heart Failure Service
University Hospital Lewisham
Lewisham High Street
London
United Kingdom
SE13 6LH |
| Contact telephone | +44 020 8333 3030 x6701 |
| Contact fax | +44 |
| Contact email | annie.o'donoghue@uhl.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN49123202 |
| Date last extracted from ISRCTN register | 17/04/2008 |
