A before and after study to investigate the effectiveness of an individual psychological intervention in reducing anxiety and depression for heart failure patients
| ISRCTN | ISRCTN49123202 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49123202 |
| Secondary identifying numbers | N0124183305 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 11/09/2012
- 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
Mrs Annie O'Donoghue
Scientific
Scientific
Heart Failure Service
University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
| Phone | +44 020 8333 3030 x6701 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Anxiety disorders |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | Significant difference between groups in depression, anxiety, coping style, self-identified problem rating, nurse identified problem rating. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2006 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key 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. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2006 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Heart Failure Service
London
SE13 6LH
United Kingdom
SE13 6LH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
University Hospital Lewisham NHS Trust (UK)
No information available
NHS R&D Support Funding
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 |
