Does counselling benefit post-myocardial infarct patients in reducing anxiety/depression and enable them to make positive life style changes in comparison to a non-counselled group?
| ISRCTN | ISRCTN06423345 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06423345 |
| Secondary identifying numbers | N0388170251 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 21/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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 E Brown
Scientific
Scientific
The Hillingdon Hospital NHS Trust
Pield Heath Road
Uxbridge
Hillingdon
UB8 3NN
United Kingdom
Study information
| Study design | Randomised controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | Does counselling benefit post-myocardial infarct patients in reducing anxiety/depression and enable them to make positive life style changes in comparison to a non-counselled group? |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Infarction |
| Intervention | Counselling vs non counselling |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Improve quality of life of myocardial infarct patients 2. Comparison of HAD scores (Hospital Anxiety & Depression scale) at six-eight weeks post-discharge and 6 months 3. The CORE (Clinical Outcome Routine Evaluation) will also be used |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2004 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 6 patients in each arm |
| Key inclusion criteria | All confirmed myocardial infarction with either an ST elevation myocardial infarctions confirmed by raised CK and SHBD and Non ST elevation myocardial infarctions confirmed by a positive Troponin T of >0.1micrograms.L-1. |
| Key exclusion criteria | 1. MI patients that do not fit the inclusion criteria 2. HAD Score at 12 weeks of below 8 and above 21 will be excluded from the study |
| Date of first enrolment | 01/02/2004 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Hillingdon Hospital NHS Trust
Hillingdon
UB8 3NN
United Kingdom
UB8 3NN
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 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
Hillingdon Hospital NHS Trust (UK)
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 |
