Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0079153958
Study information
Scientific title
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
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Mental and Behavioural Disorders: Self harm
Intervention
Guided self help (GSH) in addition to standard care compared to standard care alone.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Patient satisfaction questionnaire at end of study and coping strategy questionnaire at beginning and end of study.
Overall trial start date
02/03/2004
Overall trial end date
02/07/2005
Reason abandoned
Eligibility
Participant inclusion criteria
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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
25 patients - 2 groups
Participant exclusion criteria
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
Recruitment start date
02/03/2004
Recruitment end date
02/07/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Exeter
Exeter
EX2 5AF
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Devon Partnership NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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