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 |
| Protocol serial number | N0124183305 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funders | University Hospital Lewisham NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Significant difference between groups in depression, anxiety, coping style, self-identified problem rating, nurse identified problem rating. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Heart Failure Service
London
SE13 6LH
United Kingdom
SE13 6LH
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 |
