Condition category
Circulatory System
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
30/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.nottingham.ac.uk/

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

  1. 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.

Additional files

Editorial Notes