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ISRCTN
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ISRCTN75768347
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ClinicalTrials.gov identifier
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Public title
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A pilot study to evaluate a Guided Self-Help Programme for people who have self harmed and a follow up study of patients who have participated in Exeter GUS 1.1.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0079153958
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Study hypothesis
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To assess whether guided self help (GSH) in addition to standard care, has the potential to improve mood systems, hopelessness and social function compared to standard care alone.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and Behavioural Disorders: Self harm
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Participants - inclusion criteria
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Consecutive attendances at R&D of patients aged 16-65 years who have self harmed and are not thought to require immediate medical attention or have severe mental illness affecting their ability to consent to research or of imminent and serious suicide risk.
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Participants - exclusion criteria
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1. Children under the age of 16
2. Patients of no fixed abode, not resident in Devon, not contactable by telephone
3. Serious mental health problem or suicide risk requiring urgent admission
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Anticipated start date
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02/03/2004
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Anticipated end date
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02/07/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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25 patients - 2 groups.
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Interventions
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Guided self help (GSH) in addition to standard care compared to standard care alone.
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Primary outcome measure(s)
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Assess the potential effect size of intervention on mood and suicide risk and social function.
Measures: HAD anxiety and depression scale, Beck Hopelessness Scale, Beck suicidal intent scale. Social function questionnaire - all at 0 weeks, 2-4 weeks, and 6 weeks.
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Secondary outcome measure(s)
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Patient satisfaction questionnaire at end of study and coping strategy questionnaire at beginning and end of study.
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Sources of funding
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Devon Partnership NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Dr
Sean
Lynch
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Address
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The Department of Mental Health
University of Exeter
Wonford House Hospital
Dryden Road
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City/town
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Exeter
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Zip/Postcode
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EX2 5AF
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Country
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United Kingdom
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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24/11/2011
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Date ISRCTN assigned
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30/09/2005
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