Scottish Neurological Symptoms Study 2: Symptom Management Research Trial in Neurology
| ISRCTN | ISRCTN47705219 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47705219 |
| Secondary identifying numbers | MRC 68076 |
- Submission date
- 14/12/2005
- Registration date
- 24/01/2006
- Last edited
- 01/05/2014
- 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 Michael Sharpe
Scientific
Scientific
University of Edinburgh Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
| Phone | +44 (0)131 5376672 |
|---|---|
| michael.sharpe@ed.ac.uk |
Study information
| Study design | Two-arm two-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SNSS2: SMaRT Neurology |
| Study objectives | Patients with neurological symptoms that are diagnosed as 'not at all' or only 'somewhat' explained by disease who receive Cognitive Behavioural Self Help treatment in addition to Optimised Usual Care, will have a 10% greater mean improvement as measured on a five point clinical global improvement scale compared to patients receiving Optimised Usual Care alone, when measured 3 months after commencement of treatment. |
| Ethics approval(s) | Ethics approval received from the Scotland A Committee on 27/10/2005 (ref: 05/MRE00/96) |
| Health condition(s) or problem(s) studied | Medically unexplained symptoms |
| Intervention | 1. Optimised usual care 2. Optimised usual care with the addition of four sessions of Cognitive Behavioural Self Help Therapy by use of a manual with the support of a treating nurse specialist |
| Intervention type | Other |
| Primary outcome measure | Patients' self-rated global health improvement as measured on Clinical Global Improvement (CGI) scales at 3 months. |
| Secondary outcome measures | Patients' self rated improvement in decrease in total symptom burden, change in presenting symptoms, improvement in SF12 score, and change in Hospital Anxiety and Depression (HAD) score, Whitley score, illness beliefs and satisfaction with care |
| Overall study start date | 01/02/2006 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 |
| Key inclusion criteria | Patients aged 18 years or more who are attending Glasgow or Edinburgh Neurology Centres for the first time and who are deemed by the treating neurologist to have symptoms that are 'not at all' or only 'somewhat' explained by disease. |
| Key exclusion criteria | 1. Less than 18 years of age 2. Cognitive impairment 3. Insufficient ability to read and write English 4. Serious psychiatric illness 5. Actively suicidal 6. Receiving psychiatric or psychological treatment 7. Presenting solely with chronic daily headache 8. Neurologist/researcher considers participation inappropriate to patient's needs 9. Unable to travel to attend treatment sessions |
| Date of first enrolment | 01/02/2006 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
University of Edinburgh Division of Psychiatry
Edinburgh
EH10 5HF
United Kingdom
EH10 5HF
United Kingdom
Sponsor information
Edinburgh University (UK)
University/education
University/education
Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom
| Phone | +44 (0)131 242 9253 |
|---|---|
| Paul.McGuire@ed.ac.uk | |
"ROR" |
https://ror.org/01nrxwf90 |
Funders
Funder type
Research council
Medical Research Council (UK) (ref: 68076)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- 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 | 09/08/2011 | Yes | No |
