Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
11/09/2012
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 Annie O'Donoghue

ORCID ID

Contact details

Heart Failure Service
University Hospital Lewisham
Lewisham High Street
London
SE13 6LH
United Kingdom
+44 020 8333 3030 x6701

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0124183305

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Significant difference between groups in depression, anxiety, coping style, self-identified problem rating, nurse identified problem rating.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/2006

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/07/2006

Recruitment end date

01/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Heart Failure Service
London
SE13 6LH
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 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

University Hospital Lewisham NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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