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
Protocol serial number	N0079153958
Sponsor	Department of Health
Funder	Devon Partnership NHS Trust (UK), NHS R&D Support Funding

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

Dr Sean Lynch
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	Patient satisfaction questionnaire at end of study and coping strategy questionnaire at beginning and end of study.
Completion date	02/07/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	25
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

University of Exeter

Exeter
EX2 5AF
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan