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ISRCTN
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ISRCTN63855912
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ClinicalTrials.gov identifier
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Public title
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Psychological treatment for depression in aphasic stroke patients: a randomised controlled trial
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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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N0192165295
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Study hypothesis
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To evaluate the effectiveness of behavioural treatments for low mood following stroke in people who have communication problems.
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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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Mental and Behavioural Disorders: Depression
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Participants - inclusion criteria
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It is intended that 180 patients will be recruited, one-third (60) of these will be randomly allocated to a control group (no intervention group). Stroke patients with aphasia will be eligible for inclusion in the study. They will have been referred to the Speech & Language Therapists (SALT) in Nottingham with aphasia.
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Participants - exclusion criteria
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1. Patients will be excluded form the study if they are blind or deaf as it will not be practical to administer the assessments using standardised methods with these patients. These patients are still important, but a future study would be required to determine how assessments and therapies could be adapted for patients with severe vision and hearing problems.
2. Patients with dementia documented in their medical notes will be excluded as these patients may not have a reliable insight into their mood and the difficulties they face following their stroke.
3. Patients who received treatment for depression in the 5 years prior to their stroke will also be excluded as this study is concerned with patients who become depressed after their stroke.
4. Patients who live more than 40 miles from the recruiting centre will be excluded as it will not be practical for the researchers and therapist to visit these patients.
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Anticipated start date
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01/04/2005
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Anticipated end date
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01/12/2007
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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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180
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Interventions
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This study uses a randomised controlled trial design (RCT). In this RCT aphasic patients with low mood will be randomly allocated to one of three groups: behavioural psychotherapy, attention placebo, no intervention. The attention placebo group is required to evaluate whether any improvement in mood in the behavioural treatment group is due to the content of the therapy or the fact that patients are receiving attention and interacting with someone regularly. The no intervention group is required to examine any spontaneous recovery in mood that occurs without any additional intervention. Patients in behavioural therapy group will receive up to 20 one hour sessions of therapy. Therapy duration is at discretion of therapist. Patients in attention placebo group will receive a comparable number of visits from psychologist. Patients in control group receive no contact with psychologist. Intervention will be administered by psychologist trained with stroke patients.
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Primary outcome measure(s)
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The primary outcome measures will be completed at 3 months and 6 months after randomisation to assess mood: Visual Analogue Mood Scales (VAMS) and Stroke Aphasic Depression Questionnaire (SADQ).
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Secondary outcome measure(s)
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The secondary outcome measures will be completed at 3 months and 6 months after randomisation to assess any change in activity level: Extended Activities of Daily Living Scale (EADL) and Nottingham Leisure Questionnaire.
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Sources of funding
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Queen's Medical Centre University Hospital NHS Trust
NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Shirley
Thomas
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Address
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Research Associate
Division of Rehabilitation and Ageing
B Floor Medical School
Queens Medical Centre
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City/town
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Nottingham
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Zip/Postcode
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NG7 2UH
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Country
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United Kingdom
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Tel
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+44 (0)115 846 7484
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Fax
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+44 (0)115 942 3618
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Email
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shirley.thomas@nottingham.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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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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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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08/12/2010
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Date ISRCTN assigned
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29/09/2006
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