Evaluation of adjustment groups for people with Multiple Sclerosis

ISRCTN	ISRCTN29381417
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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Nadina Lincoln
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
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
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

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"	https://ror.org/01ee9ar58

Funders

Funder type

Charity

Multiple Sclerosis Society (UK)
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
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