Evaluation of adjustment groups for people with Multiple Sclerosis
ISRCTN | ISRCTN29381417 |
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DOI | https://doi.org/10.1186/ISRCTN29381417 |
Secondary identifying numbers | 5790 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 03/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims?
Psychological problems affect the way people cope with their disability. Depression and anxiety are common in people with multiple sclerosis (MS). Improving psychological outcomes may improve quality of life. In addition it could reduce demands on other NHS services. Although drug treatments are available, these are not appropriate for everyone. Psychological treatments may provide an alternative, but there are few high quality randomised controlled trials investigating these for people with MS. Such trials are needed in order to determine whether psychological services should be developed further. The purpose of this study was to find out whether attending group treatment sessions, which offer ways to cope with anxiety and depression, was helpful. We developed a group programme and the feedback from people who attended the groups in our pilot study was very positive. We then wished to conduct a larger study to find out whether these groups should be provided as part of routine clinical practice. The plan was to find out whether the mood of people who were offered a group treatment was better than those who were not offered the treatment and to assess the costs to the NHS of providing the service.
Who can participate?
People with MS who were known to the MS service in Nottingham
What does the study involve?
We invited people with MS to complete questionnaires about their mood. Those who had low mood, according to their questionnaire scores, were invited to take part in the study. People were allocated on the basis of chance to attend group treatment sessions or to go on a waiting list.
Group A: Everyone was offered 6 fortnightly, group treatment sessions. The sessions lasted about 2 hours, with breaks, and each session had a topic of the day, such as: worry, gloom, relationships, problem solving, and the future.
Group B. These people were not offered the group treatment until after the study was completed. They received all other clinical services as usual.
At the end of the programme, everyone, both those who attended the group and those who did not, was asked to complete questionnaires. These included measures of mood, quality of life and the impact of MS on their lives to determine the effects of the treatment. These questionnaires were repeated 3 months later to determine whether any benefits were maintained.
We also collected information on the costs of providing the service.
What are the possible benefits and risks of participating?
Participants may have had psychological treatment which would not otherwise have been available. There were no known risks associated with participating in this study.
Where is the study run from?
The MS service in Nottingham.
When is the study starting and how long is it expected to run for?
The study started in June 2008 and finished in September 2009
Who is funding the study?
Multiple Sclerosis Society (UK)
Who is the main contact?
Professor Nadina Lincoln
Nadina.Lincoln@nottingham.ac.uk
Contact information
Scientific
Institute of Work, Health & Organisations
University of Nottingham
International House
B Floor
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
United Kingdom
Study information
Study design | Randomised interventional treatment trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | AIMS |
Study objectives | Evaluation of psychological support groups based on cognitive behavoural priniciples for people with multiple sclerosis (MS) and low mood. |
Ethics approval(s) | MREC approved (ref: 04/Q2404/105) |
Health condition(s) or problem(s) studied | Topic: Neurological, Mental Health Research Network; Subtopic: Neurological (all Subtopics), Service Delivery; Disease: Anxiety, Nervous system disorders |
Intervention | Group intervention based on cognitive behavioural therapy (CBT) priniciples versus usual care. |
Intervention type | Other |
Primary outcome measure | Mood measured by the general health questionnaire (GHQ-12), follow up at 4 months and 8 months post-randomisation |
Secondary outcome measures | Hospital anxiety and depression questionnaire and Beck Depression Inventory (BDI-II) to measure mood. |
Overall study start date | 02/06/2008 |
Completion date | 30/09/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Planned Sample Size: 160 |
Key inclusion criteria | Inclusion criteria added as of 19/11/2012: 1. Give informed consent 2. Have a diagnosis of multiple sclerosis 3. Have a score of 3 or more on the General Health Questionnaire 12 or 8 or more on the Hospital Anxiety and Depression Scale depression or anxiety sub-scales i.e. they have low mood |
Key exclusion criteria | Exclusion criteria added as of 19/11/2012: 1. Less than 12 months has elapsed since diagnosis 2. Not able to speak and understand conversational English 3. Unable to attend the hospital or university for group treatment sessions if offered group treatment 4. Taking part in other psychological intervention studies |
Date of first enrolment | 02/06/2008 |
Date of final enrolment | 30/09/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NG8 1BB
United Kingdom
Sponsor information
University/education
University Park
Nottingham
NG7 2RD
England
United Kingdom
Website | http://www.nottingham.ac.uk/ |
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https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- Multiple Sclerosis Society of Great Britain and Northern Ireland, The MS Society, MS Society UK, Multiple Sclerosis Society UK, MS Society
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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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 | 01/10/2011 | Yes | No |