Does psychological treatment improve the outcome after stroke?

ISRCTN	ISRCTN33773710
DOI	https://doi.org/10.1186/ISRCTN33773710
Protocol serial number	MS33
Sponsor	Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Funder	NHS Cardiovascular Disease and Stroke National Research and Development Programme (UK)

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

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

Phone	+44 (0)113 233 2725
Email	a.o.house@leeds.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/02/2000

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

University of Leeds

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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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