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 measure
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 (if study stopped)
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
Total final enrolment
450
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
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
Basic results (scientific)
Publication list
1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11239189
2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31200668 (added 17/06/2019)