Condition category
Nervous System Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
03/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Nadina Lincoln

ORCID ID

Contact details

Institute of Work
Health & Organisations
University of Nottingham
International House
B Floor
Jubilee Campus
Wollaton Road
Nottingham
NG8 1BB
United Kingdom

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

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

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

  1. 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.

Additional files

Editorial Notes