Plain English Summary
Background and study aims
Many people who drink too much (regardless of whether they are experiencing alcohol related problems or not) do not seek treatment services. Due to the costs to the individual and society of heavy drinking, it is necessary to find ways to help those who could benefit from reducing the amount of alcohol they drink. The internet provides the opportunity to provide treatment services (i.e. interventions) to people in their own homes.There are many websites which claim to help people to change their drinking habits, but many have not been assessed for their usefulness and safety. Previous research (in Canadian adults) has demonstrated that the amount of alcohol people drink can be reduced through the use of two web-based self help methods (interventions). Here, we want to find out whether these same interventions also work in the UK , and whether a full large scale study to find out how well they work is practical.
Who can participate?
Adults (aged 18 or over) who are heavy drinkers
What does the study involve?
Participants will be randomly allocated to one of four groups. Group one will receive the Check Your Drinking site which is a basic intervention based on comparing alcohol consumption to others who are similar in age, sex and location. Group two will receive access to the Alcohol Help Center site which has more tools to explore individual alcohol use. Group three will receive access to Check Your Drinking first and Alcohol Help Centre after three months. Group four will be asked about elements they consider important in alcohol self-help programs. Participants will be contacted at the start of the study and followed up at three and six months. They will also be contacted (and separate consent will be given) to take part in qualitative interviews to discuss their experience in more depth.
What are the possible benefits and risks of participating?
Information from this study will be used to develop future alcohol self-help program, to better understand alcohol use and to develop trial methods in online interventions. Participants receive £10 vouchers for each questionnaire returned. There are limited risks to taking part but participants will be informed of sources of help should they have concerns about either their own or others alcohol use. There are both general contact details (Alcohol Concern) and more specific details for each region of the UK.
Where is the study run from?
University of Ulster (UK)
When is the study starting and how long is it expected to run for?
The study will start recruitment in August 2014 and follow up will end in March 2015. The study will continue until December 2015.
Who is funding the study?
The HSC research and development division of the Public Health Agency (Northern Ireland) (UK)
Who is the main contact?
Dr Gillian W Shorter
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
STL/4971/14
Study information
Scientific title
Self Help Interventions to Reduce Alcohol Consumption
Acronym
SHIRAC
Study hypothesis
As this is a feasibility (external) pilot study the aims are:
1. To assess the impact of minimal and full internet based self help interventions for hazardous drinkers in the UK compared with no intervention control
2. To determine the rates of recruitment and retention using online methods and evidence the feasibility of the trial methods in the UK context
3. To understand the barriers and facilitators of behavior change in hazardous drinkers in the UK context (using qualitative research methods)
Ethics approval
University of Ulster, Psychology Filter Committee, 05/08/2014
Study design
Randomized allocation to one of four arms; Masking: Double blind (subject and statistician assessing outcomes) Single centre
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Heavy alcohol use, alcohol dependence
Intervention
Behavioural: Check your drinking (CYD)
Internet based programe of lower intensity compared to the Alcohol Help Centre. Designed to assess drinking patterns, increase awareness of triggers and set/achieve goals related to alcohol use reduction.
Behavioural; Alcohol Help Centre (AHC)
Internet based program of higher intensity as compared to the CYD intervention above. Designed to assess drinking patterns, increase self-awareness of individual triggers and set or achieve alcohol reduction goals. Designed for repeated use.
Arm one receives CYD
Arm two AHC
Arm three CYD then AHC three months later
Arm four receives a no intervention control but are asked to describe what they would consider key components of alcohol self-help interventions to be
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Alcohol consumption as measured by the total score on the Alcohol Use Disorders Identification Test, quantity and frequency of past month alcohol consumption, highest number of drinks on occasion, and standard drinks consumed in the past week. Measured at baseline, three months and six month intervals.
Secondary outcome measures
1. Alcohol Use Disorders Identification Test - Consumption factor
2. Alcohol Use Disorders Identification Test - Problem factor
3. Drinking refusal self-efficacy
4. Rates of recruitment and retention
5. Intervention use
6. Barriers and facilitators of change
Overall trial start date
25/08/2014
Overall trial end date
31/12/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Resident in the UK
2. Aged 18 years or over
3. Hazardous drinking indicated by a score of eight or more on the Alcohol Use Disorders Identification Test
4. Access to the internet
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Around 400 randomized from 1000 recruited
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
25/08/2014
Recruitment end date
31/12/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Ulster
Londonderry
BT48 7JL
United Kingdom
Sponsor information
Organisation
HSC Public Health Agency Research & Development Division (UK)
Sponsor details
Public Health Agency
12-22 Linenhall Street
Belfast
BT2 8BS
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
HSC Research & Development Division, Public Health Agency, Northern Ireland (UK): Reference STL/4971/14
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