Communication And Low Mood (CALM) study
| 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
Scientific
Institute of Work, Health & Organisations
University of Nottingham
International House
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
United Kingdom
| shirley.thomas@nottingham.ac.uk |
Study information
| Study design | Multicentre randomised interventional process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | CALM |
| Study objectives | 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(s) | Nottingham Research Ethics Committee approved on the 8th December 2004 (ref: 04/Q2403/148) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 21/10/2005 |
| Completion date | 30/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 30; UK sample size: 30 |
| Key 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 |
| Key exclusion criteria | 1. Dementia 2. Blind or deaf 3. Received treatment for depression in the five years prior to stroke |
| Date of first enrolment | 21/10/2005 |
| Date of final enrolment | 30/06/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute of Work, Health & Organisations
Nottingham
NG8 1BB
United Kingdom
NG8 1BB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
