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
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

The Department of Mental Health
University of Exeter
Wonford House Hospital
Dryden Road
Exeter
EX2 5AF
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA 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 objectivesTo 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) studiedMental and Behavioural Disorders: Self harm
InterventionGuided self help (GSH) in addition to standard care compared to standard care alone.
Intervention typeOther
Primary outcome measureAssess 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 measuresPatient satisfaction questionnaire at end of study and coping strategy questionnaire at beginning and end of study.
Overall study start date02/03/2004
Completion date02/07/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants25 patients - 2 groups
Key inclusion criteriaConsecutive 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 criteria1. 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 enrolment02/03/2004
Date of final enrolment02/07/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Exeter
Exeter
EX2 5AF
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan