Condition category
Mental and Behavioural Disorders
Date applied
14/12/2005
Date assigned
24/01/2006
Last edited
01/05/2014
Prospective/Retrospective
Prospectively 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 Michael Sharpe

ORCID ID

Contact details

University of Edinburgh Division of Psychiatry
Kennedy Tower
Royal Edinburgh Hospital
Edinburgh
EH10 5HF
United Kingdom
+44 (0)131 5376672
michael.sharpe@ed.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MRC 68076

Study information

Scientific title

Acronym

SNSS2: SMaRT Neurology

Study hypothesis

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

Ethics approval received from the Scotland A Committee on 27/10/2005 (ref: 05/MRE00/96)

Study design

Two-arm two-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2006

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

130

Participant 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

Recruitment start date

01/02/2006

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Edinburgh Division of Psychiatry
Edinburgh
EH10 5HF
United Kingdom

Sponsor information

Organisation

Edinburgh University (UK)

Sponsor details

Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 9253
Paul.McGuire@ed.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: 68076)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21795652

Publication citations

  1. Results

    Sharpe M, Walker J, Williams C, Stone J, Cavanagh J, Murray G, Butcher I, Duncan R, Smith S, Carson A, Guided self-help for functional (psychogenic) symptoms: a randomized controlled efficacy trial., Neurology, 2011, 77, 6, 564-572, doi: 10.1212/WNL.0b013e318228c0c7.

Additional files

Editorial Notes