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ISRCTN
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ISRCTN56078830
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ClinicalTrials.gov identifier
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Public title
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Communication And Low Mood (CALM) study
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Scientific title
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Communication and Low Mood: a multicentre randomised controlled trial of behaviour therapy aimed at improving mood in people with aphasia following a stroke
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Acronym
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CALM
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Serial number at source
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2497
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Study hypothesis
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Over 130,000 people have a stroke each year in England and Wales and about one third of these will have aphasia (communication impairment). This can mean they have difficulty speaking, reading, writing or understanding language.
Depression is common in people who have had a stroke and can have a negative effect on rehabilitation. There is some evidence that people with aphasia are more likely to become depressed. However, people with aphasia are usually excluded from research into mood after stroke and depression is often not treated.
The CALM study is divided into two parts: a survey and a treatment trial.
Survey:
Part one of the study is a survey to find out what factors are related to low mood in people with aphasia due to a stroke, for example, disability and severity of aphasia. It will provide useful clinical information to aid the identification of those who are at risk of having low mood and will inform the development of effective interventions.
Treatment Trial:
Part two of the study is a multicentre randomised controlled trial to evaluate whether a psychological treatment, called behaviour therapy, is effective at treating low mood in people with aphasia due to a stroke. Behaviour therapy aims to improve mood by increasing the time people spend doing things they enjoy. This is relevant for people with aphasia who may stop doing everyday activities and hobbies after their stroke. Behaviour therapy is appropriate for people with aphasia as it is practical and can be adapted for people with communication problems.
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Lay summary
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Ethics approval
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Nottingham Research Ethics Committee approved on the 8th December 2004 (ref: 04/Q2403/148)
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Study design
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Multicentre randomised interventional process of care 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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Topic: Stroke Research Network, Mental Health Research Network; Subtopic: Rehabilitation, Mental effects due to physical disease or brain damage; Disease: Depression, Therapy type
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Participants - inclusion criteria
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1. Stroke
2. Aphasia
3. Low mood (greater than 6 on Stroke Aphasic Depression Questionnaire Hospital Version [SADQ-H] or greater than 50 on "sad" subscale of Visual Analogue Mood Scales [VAMS])
4. Aged at learst 18 years old, either sex
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Participants - exclusion criteria
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1. Dementia
2. Blind or deaf
3. Received treatment for depression in the five years prior to stroke
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Anticipated start date
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21/10/2005
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 30; UK sample size: 30
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Interventions
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Behaviour therapy:
This consists of up to 20 one hour sessions of therapy for up to three months from an assistant psychologist delivered at the patient's place of residence (e.g. at home, in hospital, in a nursing home).
Control group:
Usual care for three month period.
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Primary outcome measure(s)
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Stroke Aphasic Depression Questionnaire (SADQ; 21 item hospital version), measured 3 and 6 months after randomisation.
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Secondary outcome measure(s)
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Measured 3 and 6 months after randomisation:
1. Visual Analogue Mood Scales (VAMS) 'sad' item
2. Visual Analogue Self-Esteem Scale (VASES)
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Sources of funding
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The Stroke Association (UK)
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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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Institute of Work, Health & Organisations
University of Nottingham
International House
Jubilee Campus
Wollaton Road
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City/town
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Nottingham
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Zip/Postcode
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NG8 1BB
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Country
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United Kingdom
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Email
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shirley.thomas@nottingham.ac.uk
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Sponsor
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University of Nottingham (UK)
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Address
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University Park
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City/town
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Nottingham
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Zip/Postcode
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NG7 2RD
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Country
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United Kingdom
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Sponsor website:
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http://www.nottingham.ac.uk/
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Date applied
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24/06/2010
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Last edited
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18/11/2010
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Date ISRCTN assigned
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24/06/2010
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