Evaluation of adjustment groups for people with Multiple Sclerosis: a pilot study
| ISRCTN | ISRCTN13272820 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13272820 |
| Protocol serial number | N/A |
| Sponsor | University of Nottingham (UK) |
| Funder | University of Nottingham (UK) |
- 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
Scientific
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 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial for approximately one year |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
By providing the participants with skills to manage mood, it was hoped that they would experience fewer difficulties with their mood in the future. |
| Key secondary outcome measure(s) |
1. Hospital Anxiety and Depression Scale |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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
- United Kingdom
- England
Study participating centre
Institute of Work, Health & Organisations
Nottingham
NG81 1BB
United Kingdom
NG81 1BB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
