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ISRCTN
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ISRCTN33773710
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ClinicalTrials.gov identifier
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Public title
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Does psychological treatment improve the outcome after stroke?
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Scientific title
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Acronym
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N/A
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Serial number at source
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MS33
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cerebrovascular disease, stroke
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Patients with significant cognitive or communication difficulties
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Anticipated start date
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01/06/1995
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Anticipated end date
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01/02/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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448
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Interventions
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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
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
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Trial website
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Publications
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Contact name
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Prof
Allan
House
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Address
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Department of Psychiatry
University of Leeds
15 Hyde Terrace
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City/town
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Leeds
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Zip/Postcode
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LS2 9LT
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Country
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United Kingdom
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Tel
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+44 (0)113 233 2725
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Fax
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+44 (0)113 243 3719
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Email
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a.o.house@leeds.ac.uk
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Sponsor
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Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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08/12/2009
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Date ISRCTN assigned
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23/01/2004
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