Evaluation of adjustment groups for people with Multiple Sclerosis: a pilot study

ISRCTN	ISRCTN13272820
DOI	https://doi.org/10.1186/ISRCTN13272820
Secondary identifying numbers	N/A

Submission date: 30/04/2012
Registration date: 13/06/2012
Last edited: 05/12/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nadina Lincoln
Scientific

Institute of Work, Health & Organisations
University of Nottingham
International House
B Floor
Jubilee Campus
Wollaton Road
Nottingham
NG81 1BB
United Kingdom

Email	nadina.lincoln@nottingham.ac.uk

Study information

Study design	Randomised controlled trial for approximately one year
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A pilot randomised controlled trial to evaluate an adjustment group for people with multiple sclerosis
Study objectives	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(s)	Nottingham Local Research Ethics Committee
Health condition(s) or problem(s) studied	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
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 study start date	01/10/2004
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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.
Key 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
Key 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.
Date of first enrolment	01/10/2004
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Work, Health & Organisations

Nottingham
NG81 1BB
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

c/o Prof Nadina Lincoln
Institute of Work, Health & Organisations
International House
B Floor
Jubilee Campus
Wollaton Road
Nottingham
NG81 1BB
England
United Kingdom

Phone	+44 (0)115 846 7523
Email	I-WHO@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/iwho/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

University/education

University of Nottingham (UK)
Private sector organisation / Universities (academic only)

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	01/03/2010		Yes	No