Contact information
Type
Scientific
Primary contact
Dr Shirley Thomas
ORCID ID
Contact details
Institute of Work
Health & Organisations
University of Nottingham
International House
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
United Kingdom
shirley.thomas@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2497
Study information
Scientific title
Communication and Low Mood: a multicentre randomised controlled trial of behaviour therapy aimed at improving mood in people with aphasia following a stroke
Acronym
CALM
Study hypothesis
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.
Ethics approval
Nottingham Research Ethics Committee approved on the 8th December 2004 (ref: 04/Q2403/148)
Study design
Multicentre randomised interventional process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Stroke Research Network, Mental Health Research Network; Subtopic: Rehabilitation, Mental effects due to physical disease or brain damage; Disease: Depression, Therapy type
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Stroke Aphasic Depression Questionnaire (SADQ; 21 item hospital version), measured 3 and 6 months after randomisation.
Secondary outcome measures
Measured 3 and 6 months after randomisation:
1. Visual Analogue Mood Scales (VAMS) 'sad' item
2. Visual Analogue Self-Esteem Scale (VASES)
Overall trial start date
21/10/2005
Overall trial end date
30/06/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 30; UK sample size: 30
Participant exclusion criteria
1. Dementia
2. Blind or deaf
3. Received treatment for depression in the five years prior to stroke
Recruitment start date
21/10/2005
Recruitment end date
30/06/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Work, Health & Organisations
Nottingham
NG8 1BB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
University Park
Nottingham
NG7 2RD
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Stroke Association (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
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23059701
Publication citations
-
Results
Thomas SA, Walker MF, Macniven JA, Haworth H, Lincoln NB, Communication and Low Mood (CALM): a randomized controlled trial of behavioural therapy for stroke patients with aphasia., Clin Rehabil, 2013, 27, 5, 398-408, doi: 10.1177/0269215512462227.