Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0388170251
Study information
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?
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Cardiovascular: Infarction
Intervention
Counselling vs non counselling
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
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 trial start date
01/02/2004
Overall trial end date
01/01/2007
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
6 patients in each arm
Participant 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
Recruitment start date
01/02/2004
Recruitment end date
01/01/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Hillingdon Hospital NHS Trust
Hillingdon
UB8 3NN
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Hillingdon Hospital NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary