ISRCTN ISRCTN56078830
DOI https://doi.org/10.1186/ISRCTN56078830
Secondary identifying numbers 2497
Submission date
24/06/2010
Registration date
24/06/2010
Last edited
30/11/2012
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

Dr Shirley Thomas
Scientific

Institute of Work, Health & Organisations
University of Nottingham
International House
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
United Kingdom

Email shirley.thomas@nottingham.ac.uk

Study information

Study designMulticentre randomised interventional process of care trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCommunication and Low Mood: a multicentre randomised controlled trial of behaviour therapy aimed at improving mood in people with aphasia following a stroke
Study acronymCALM
Study objectivesOver 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(s)Nottingham Research Ethics Committee approved on the 8th December 2004 (ref: 04/Q2403/148)
Health condition(s) or problem(s) studiedTopic: Stroke Research Network, Mental Health Research Network; Subtopic: Rehabilitation, Mental effects due to physical disease or brain damage; Disease: Depression, Therapy type
InterventionBehaviour 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 typeOther
Primary outcome measureStroke Aphasic Depression Questionnaire (SADQ; 21 item hospital version), measured 3 and 6 months after randomisation.
Secondary outcome measuresMeasured 3 and 6 months after randomisation:
1. Visual Analogue Mood Scales (VAMS) 'sad' item
2. Visual Analogue Self-Esteem Scale (VASES)
Overall study start date21/10/2005
Completion date30/06/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned sample size: 30; UK sample size: 30
Key inclusion criteria1. 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
Key exclusion criteria1. Dementia
2. Blind or deaf
3. Received treatment for depression in the five years prior to stroke
Date of first enrolment21/10/2005
Date of final enrolment30/06/2011

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Institute of Work, Health & Organisations
Nottingham
NG8 1BB
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

University Park
Nottingham
NG7 2RD
England
United Kingdom

Website http://www.nottingham.ac.uk/
ROR logo "ROR" https://ror.org/01ee9ar58

Funders

Funder type

Charity

The Stroke Association (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2013 Yes No