Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
5790
Study information
Scientific title
Acronym
AIMS
Study hypothesis
Evaluation of psychological support groups based on cognitive behavoural priniciples for people with multiple sclerosis (MS) and low mood.
Ethics approval
MREC approved (ref: 04/Q2404/105)
Study design
Randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
02/06/2008
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned Sample Size: 160
Participant 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
Recruitment start date
02/06/2008
Recruitment end date
30/09/2009
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
Multiple Sclerosis Society (UK)
Alternative name(s)
MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
professional associations and societies
Location
United Kingdom
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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21613332
Publication citations
-
Results
Lincoln NB, Yuill F, Holmes J, Drummond AE, Constantinescu CS, Armstrong S, Phillips C, Evaluation of an adjustment group for people with multiple sclerosis and low mood: a randomized controlled trial., Mult. Scler., 2011, 17, 10, 1250-1257, doi: 10.1177/1352458511408753.