ISRCTN ISRCTN92071123
DOI https://doi.org/10.1186/ISRCTN92071123
Secondary identifying numbers STL/4971/14
Submission date
12/08/2014
Registration date
22/08/2014
Last edited
18/12/2020
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

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

Contact information

Dr Gillian Shorter
Scientific

University of Ulster, Northland Road
Londonderry
BT48 7JL
United Kingdom

Study information

Study designRandomized allocation to one of four arms; Masking: Double blind (subject and statistician assessing outcomes) Single centre
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Internet/virtual
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleSelf Help Interventions to Reduce Alcohol Consumption
Study acronymSHIRAC
Study objectivesAs 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(s)University of Ulster, Psychology Filter Committee, 05/08/2014
Health condition(s) or problem(s) studiedHeavy alcohol use, alcohol dependence
InterventionBehavioural: 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 typeOther
Primary outcome measureAlcohol 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 measures1. 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 study start date25/08/2014
Completion date31/12/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsAround 400 randomized from 1000 recruited
Key inclusion criteria1. 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
Key exclusion criteriaNot provided at time of registration
Date of first enrolment25/08/2014
Date of final enrolment31/12/2015

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

University of Ulster
Londonderry
BT48 7JL
United Kingdom

Sponsor information

HSC Public Health Agency Research & Development Division (UK)
Government

Public Health Agency
12-22 Linenhall Street
Belfast
BT2 8BS
United Kingdom

Website http://www.publichealth.hscni.net
ROR logo "ROR" https://ror.org/03ek62e72

Funders

Funder type

Government

HSC Research & Development Division, Public Health Agency, Northern Ireland (UK): Reference STL/4971/14

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

Editorial Notes

18/12/2020: Internal review.
12/01/2018: No publications found, verifying study status with principal investigator.