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
Protocol serial number N0388170251
Sponsor Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder Hillingdon Hospital NHS Trust (UK)
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

The Hillingdon Hospital NHS Trust
Pield Heath Road
Uxbridge
Hillingdon
UB8 3NN
United Kingdom

Study information

Primary study designInterventional
Study designRandomised controlled study
Secondary study designRandomised controlled trial
Scientific titleDoes 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 objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCardiovascular: Infarction
InterventionCounselling vs non counselling
Intervention typeBehavioural
Primary outcome measure(s)

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

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target sample size at registration12
Key inclusion criteriaAll 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 criteria1. 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 enrolment01/02/2004
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

The Hillingdon Hospital NHS Trust
Hillingdon
UB8 3NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan