Condition category
Circulatory System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/03/2016
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

Prof Allan House

ORCID ID

Contact details

Department of Psychiatry
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
+44 (0)113 233 2725
a.o.house@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MS33

Study information

Scientific title

Does psychological treatment improve the outcome after stroke?

Acronym

Study hypothesis

Depressed mood may affect about 40% of elderly people after a stroke, especially during the first year. It is a major determinant of quality of life for patients and carers, and may delay functional and social recovery. The condition may not be recognised, and even if it is, the best treatment is not known.
The aim of this study was to assess the effectiveness of a psychological intervention.

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

Other

Trial type

Quality of life

Patient information sheet

Condition

Cerebrovascular disease, stroke

Intervention

1. Psychiatric nurse therapist offering six hourly sessions of a problem-solving type of cognitive- behaviour therapy
2. Voluntary visitor with no special training offering a similar time of support and advice
3. Nothing beyond normal rehabilitation

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patients and carers were assessed at entry, at 6 months and at 12 months.
Measurements of patients comprised:
1.1. Present State Examination
1.2. General Health Questionnaire 28 (GHQ-28)
1.3. Beck Hopelessness scale
1.4. Frenchay Activities Index
1.5. Barthel ADL Scale
1.6. Mini Mental State Exam,
1.7. Nottingham Health Profile
2. Carers were assessed by
2.1. GHQ-28
2.2. Nottingham Health Profile
2.3. Social Adjustment Scale
2.4. Carers Strain Index
3. Information was also collected on contacts with general practitioners and hospital service, use of medication especially antidepressants, and satisfaction with care received.
4. Resource use over the 12 months was also measured.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1995

Overall trial end date

01/02/2000

Reason abandoned

Eligibility

Participant inclusion criteria

448 patients were recruited from hospitals in Leeds and Bradford within one month of suffering a stroke. Median age of patients was 73, and 40% lived alone.

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

448

Participant exclusion criteria

Patients with significant cognitive or communication difficulties

Recruitment start date

01/06/1995

Recruitment end date

01/02/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Department of Psychiatry 15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Cardiovascular Disease and Stroke National Research and Development Programme (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

2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11239189

Publication citations

Additional files

Editorial Notes

18/03/2016: Publication reference added