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
ISRCTN | ISRCTN75768347 |
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DOI | https://doi.org/10.1186/ISRCTN75768347 |
Secondary identifying numbers | N0079153958 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 16/04/2015
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Sean Lynch
Scientific
Scientific
The Department of Mental Health
University of Exeter
Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Mental and Behavioural Disorders: Self harm |
Intervention | Guided self help (GSH) in addition to standard care compared to standard care alone. |
Intervention type | Other |
Primary outcome measure | 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 study start date | 02/03/2004 |
Completion date | 02/07/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 25 patients - 2 groups |
Key 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. |
Key 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 |
Date of first enrolment | 02/03/2004 |
Date of final enrolment | 02/07/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Exeter
Exeter
EX2 5AF
United Kingdom
EX2 5AF
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Devon Partnership NHS Trust (UK), NHS R&D Support Funding
No information available
Results and Publications
Intention to publish date | |
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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 |