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
NG81 1BB
United Kingdom
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nadina.lincoln@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A pilot randomised controlled trial to evaluate an adjustment group for people with multiple sclerosis
Acronym
Study hypothesis
There is consensus that the prevalence of depression in people with multiple sclerosis is high. Previous studies have mainly used cognitive behaviour therapy for multiple sclerosis patients with low mood or support groups for multiple sclerosis patients in general.
The aim of this study was to assess the effectiveness of a support group, based on cognitive behavioural principles, for patients with multiple sclerosis experiencing low mood.
Ethics approval
Nottingham Local Research Ethics Committee
Study design
Randomised controlled trial for approximately one year
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low mood in people with Multiple Sclerosis
Intervention
The study involved 8 male and 32 females recruited from multiple sclerosis outpatient clinics at Queens Medical Centre, Nottingham and by posters at the Multiple Sclerosis Society office and in their Society newsletter Participation will be over a 1-year period.
The sessions were based on a cognitive behavioural and psycho-educational framework. They were designed to teach individuals to identify and deploy skills to reduce current and future distress, thus aiding coping and adjustment. The sessions were also intended to increase awareness of the role of thoughts, emotions and behaviours and their influence on each other.
Participants in the control group received no psychological intervention but had access to all other services as usual. They were offered group treatment after the six-month outcome had been completed.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
By providing the participants with skills to manage mood, it was hoped that they would experience fewer difficulties with their mood in the future.
Secondary outcome measures
1. Hospital Anxiety and Depression Scale
2. General Health Questionnaire 12
3. Multiple Sclerosis Self Efficacy Scale
4. Multiple Sclerosis Impact Scale
5. Short Form 36 administered 3 and 6 months after random allocation
Overall trial start date
01/10/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All patients with a score of more than 7 on either the anxiety or depression scales on the Hospital Anxiety and Depression Scale or more than 2 on the General Health Questionnaire12 and who had a diagnosis of multiple sclerosis for more than three months
2. Able to speak and understand conversational English
3. Able to attend the University for the group intervention
4. Not involved in any other intervention study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100,000 prevalence in the UK. Unsure of number of people with MS registered in the Nottingham area. 40 patients enrolled.
Participant exclusion criteria
1. Unable to speak and understand conversational English.
2. Unable to attend the University for the group intervention
3. Involved in another intervention study.
Recruitment start date
01/10/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Work, Health & Organisations
Nottingham
NG81 1BB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
c/o Prof Nadina Lincoln
Institute of Work
Health & Organisations
International House
B Floor
Jubilee Campus
Wollaton Road
Nottingham
NG81 1BB
United Kingdom
+44 (0)115 846 7523
I-WHO@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Nottingham (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
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
Basic results (scientific)
Publication list
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20026575
Publication citations
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Results
Forman AC, Lincoln NB, Evaluation of an adjustment group for people with multiple sclerosis: a pilot randomized controlled trial., Clin Rehabil, 2010, 24, 3, 211-221, doi: 10.1177/0269215509343492.