Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
21/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs E Brown

ORCID ID

Contact details

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

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes