An exploratory randomised trial of brief intervention for alcohol misuse among people who self harm and misuse alcohol: impact on repetition of self harm

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Mike Crawford
Scientific

Department of Psychological Medicine
Claybrook Centre
37, Claybrook Road
London
W6 8LN
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SHARP (Self Harm Alcohol Reduction Programme)
Study objectives	Among people who present to emergency hospital services following deliberate self harm and are found to be misusing alcohol, the proportion who repeat self harm over the following six months will be lower among those offered a self-help leaflet and an appointment for brief intervention from an Alcohol Health Worker than among those who receive a self-help leaflet on alcohol and health.
Ethics approval(s)	West London REC 2 on 24/05/2010 10/H0706/29
Health condition(s) or problem(s) studied	Alcohol misuse
Intervention	Experimental treatment: A leaflet on alcohol and health together with an appointment card asking the patient to attend an appointment with an Alcohol Health Worker (AHW). The AHW will provide a single session of assessment, brief counselling based on the FRAMES approach (Bien et al., 1993), and referral on to other services. Control treatment (CT): A leaflet on alcohol and health
Intervention type	Other
Primary outcome measure(s)	Repetition of deliberate self harm over the following 6 months (as measured by self report together with an examination of hospital records).
Key secondary outcome measure(s)	Level of alcohol consumption, mental health and satisfaction with care at six months
Completion date	31/08/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	270
Key inclusion criteria	All those aged over 18 years or over, who are found to be misusing alcohol (according to the Paddington Alcohol Test), and have an address in the local area (within the M25).
Key exclusion criteria	All those unwilling to provide informed consent to participate in the trial, all those unable to complete baseline assessment because of an inability to communicate in English, and all those who are already in contact with alcohol misuse services will be excluded from the study.
Date of first enrolment	01/09/2005
Date of final enrolment	31/08/2007

Department of Psychological Medicine

London
W6 8LN
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2010		Yes	No