Does psychological treatment improve the outcome after stroke?
| ISRCTN | ISRCTN33773710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33773710 |
| Secondary identifying numbers | MS33 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 17/06/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Allan House
Scientific
Scientific
Department of Psychiatry
University of Leeds
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
| Phone | +44 (0)113 233 2725 |
|---|---|
| a.o.house@leeds.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Scientific title | Does psychological treatment improve the outcome after stroke? |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/06/1995 |
| Completion date | 01/02/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 448 |
| Total final enrolment | 450 |
| Key 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. |
| Key exclusion criteria | Patients with significant cognitive or communication difficulties |
| Date of first enrolment | 01/06/1995 |
| Date of final enrolment | 01/02/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Leeds
Department of Psychiatry
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
15 Hyde Terrace
Leeds
LS2 9LT
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2001 | Yes | No | |
| Results article | results | 14/06/2019 | 17/06/2019 | Yes | No |
Editorial Notes
17/06/2019: Publication reference and total final enrolment added.
18/03/2016: Publication reference added
