Condition category
Mental and Behavioural Disorders
Date applied
30/04/2012
Date assigned
13/06/2012
Last edited
05/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

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
NG81 1BB
United Kingdom
-
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 measures

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

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

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

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20026575

Publication citations

  1. 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.

Additional files

Editorial Notes