Plain English Summary
Background and study aims
Alcohol misuse is a major cause of premature death and ill-health. Europe has the highest number of alcohol related illnesses in the world and alcohol accounts for approximately 1.8 million deaths. Although a high number of people are admitted to hospital with an illness linked to drinking alcohol, many are unaware that they have an alcohol problem. This means that they often do not directly seek treatment for their drinking. Providing specialist treatment for such problem drinkers can reduce use of the NHS as well as improving the health and social benefits for the individuals. A person's overall health lifestyle can often be linked to the amount of alcohol they drink and problem drinkers are likely to have a range of lifestyle problems (for example, smoking and obesity). It has been suggested that having a healthy or balanced lifestyle could possibly help reduce or stop alcohol use, and prevent relapse.
This initial study aims to look at whether a treatment focused on healthy living is better at reducing someone's alcohol intake than a treatment focused on alcohol alone.
Who can participate?
To take part you need to:
1. Be aged 18 years and older
2. Have been admitted to hospital with an illness linked to drinking alcohol
3. Score 16 or more on the modified Alcohol Use Disorders Identification Test
What does the study involve?
You will be randomly allocated to one of the following treatments:
1. An alcohol focused treatment: this is a social network based treatment for helping people to resolve their drinking problems, by reducing the amount they drink or becoming abstinent. You would be encouraged to seek the help of concerned and supportive others and to plan alternative activities to drinking and make relapse prevention plans.
2. A healthy living treatment: this would involve choosing three healthy living subject areas from a choice of seven. If you appear to have particular problems in an area, you would be encouraged to feel positive about addressing them. Treatment would begin with one session on each chosen area with a review at the beginning of the next session and a review of the success of the programme as the fourth session. You would be encouraged to invite a friend to participate in the behaviour change plans you draw up for each subject.
You will receive four sessions of your allocated treatment, each lasting 30 to 45 minutes, over a maximum period of eight weeks. You will also be asked to complete some questionnaires during your time on the study (at the start, after 6 months and after 12 months). We are also interested in talking to people about how they feel about being told their alcohol drinking could be a problem and how they felt being approached about this study. This will provide an opportunity for you to discuss your feelings and thoughts about being told that your diagnosis may be related to drinking alcohol. Even if you choose not to be allocated to a treatment, you can still talk to a researcher about your experiences if you would like to.
What are the possible benefits and risks of participating?
You will receive advice on reducing your drinking although we cannot promise the study will definitely help you. The information we get from this study will help to answer the question as to whether one of these treatments is better than the other. There are no known risks to participants.
Where is the study run from?
This study is being organised by Leeds Addiction Unit and the University of York. Patients will be recruited from Leeds General Infirmary and St James's Hospital in Leeds.
When is the study starting and how long is it expected to run for?
Patients will be recruited from approximately March 2012 until October 2012.
Who is funding the study?
National Institute of Health Research Collaborations for Leadership in Applied Health Research and Care (CLAHRC) programme.
Who is the main contact?
Dr Judith Watson
jude.watson@york.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.0
Study information
Scientific title
A randomised controlled trial of an alcohol focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting: a pilot study
Acronym
ADAPTA
Study hypothesis
A healthy living intervention with its broader focus on up to three lifestyle domains out of a choice of diet, exercise, smoking, drinking, personal care, drug use and medication concordance will have greater acceptability, and therefore be more effective, than a more specific focus on drinking alcohol behaviour change in a non help seeking population of problem drinkers.
Ethics approval
Not provided at time of registration
Study design
Pragmatic qualitative randomised controlled open pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Generic Health Relevance, alcohol consumption, problem drinkers
Intervention
1. An alcohol focused intervention - a manually driven, social network based, cognitive behavioural intervention using motivational dialogue with a strong evidence base in UK clinical trials and is increasingly commonly taught and practised in the UK addiction field
2. A healthy living intervention - a manually driven intervention which targets a possible seven domains (maximum of three) which contribute to overall health: diet, exercise, drinking, smoking and medication concordance, drug use and personal care
Both groups will receive four sessions (30-45 minutes each) delivered one to two weeks apart, over a maximum period of eight weeks.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
AUDIT score at six months post randomisation
Secondary outcome measures
1. Qualitative research: The acceptability of the assessment process and interventions will be explored in order to inform future practice by means of semi-structured interviews. These interviews will add to the quantitative measures detailed below, in addressing the acceptability of these interventions and the possible mechanism of their impacts.
2. Dependence: Dependence will be measured at baseline, six and 12 months using the Leeds Dependence Questionnaire (LDQ)
3. Social Satisfaction: Social satisfaction will be measured at baseline, six and 12 months using the Social Satisfaction Questionnaire (SSQ).
4. Clinical Outcomes in Routine Evaluation (CORE-10): Subjective well-being, psychological problems and functioning using the Clinical Outcomes in Routine Evaluation (CORE-10) will be assessed at baseline, six and 12 months post randomisation
5. Health-related quality of life (HRQoL): HRQoL will be assessed at baseline, six and 12 months post randomisation using the European Quality of Life - 5 Dimensions (EQ-5D)
6. Costs: Costs of delivering a healthy living intervention and those of the alcohol focused intervention will be measured by recording the resources utilised in the identification and delivery of both interventions. Participant use of health services, other alcohol services outside the study, public services and criminal justice services will be assessed using a service use questionnaire at baseline, six and 12 months post randomisation
Overall trial start date
01/02/2012
Overall trial end date
31/10/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women aged 18 years and over
2. Admitted to St James's Hospital and/or Leeds General Infirmary
3. Diagnosis likely to be responsive to addiction interventions, scoring equal to or more than 16 on the modified Alcohol Use Disorders Identification Test (AUDIT)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
222
Participant exclusion criteria
1. Aged less than 18 years of age at the time of screening
2. Have received specialist treatment with a primary focus on alcohol in the past 6 weeks
3. No-fixed abode (i.e. not available for follow-up)
4. Currently serving a sentence in prison or outstanding legal issues likely to lead to imprisonment (i.e. not available for follow-up)
5. Mental or physical illness likely to preclude active participation in treatment or follow up (e.g. not stable through current medication/treatment)
6. Unwilling to give written informed consent
7. Unable to give written informed consent
8. Unable to take part in either intervention using spoken English
9. Unable to self-complete the English language outcome measure tools
Recruitment start date
01/03/2012
Recruitment end date
01/10/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Addiction Unit
Leeds
LS2 9NG
United Kingdom
Sponsor information
Organisation
Leeds Partnerships NHS Foundation Trust (UK)
Sponsor details
c/o Dr James Hughes
Research and Development
North Wing St Mary's House
St Mary's Road
Leeds
LS7 3LA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute of Health Research (NIHR) (UK) - Collaborations for Leadership in Applied Health Research and Care (CLAHRC) programme
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
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782907
Publication citations
-
Protocol
Watson J, Tober G, Raistrick D, Mdege N, Dale V, Crosby H, Godfrey C, Lloyd C, Toner P, Parrott S, , An alcohol-focused intervention versus a healthy living intervention for problem drinkers identified in a general hospital setting (ADAPTA): study protocol for a randomized, controlled pilot trial., Trials, 2013, 14, 117, doi: 10.1186/1745-6215-14-117.