Brief intervention to improve alcohol consumption and co-morbid outcomes in primary care patients with hypertension or mild to moderate depression

ISRCTN	ISRCTN89156543
DOI	https://doi.org/10.1186/ISRCTN89156543
Protocol serial number	10SUBM001
Sponsor	North Tyneside Primary Care Trust (UK)
Funder	North Tyneside NHS Primary Care Trust (UK)

Submission date: 23/08/2013
Registration date: 21/10/2013
Last edited: 30/06/2014

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

Plain English summary of protocol

Background and study aims
Some people living with high blood pressure or mild to moderate depression also drink alcohol over medically recommended levels. If they change the amount or the way in which they drink their symptoms may improve. Brief advice is known to help people who drink excessively to reduce their alcohol consumption, and may also lead to improvements in associated high blood pressure or mental health problems. A large study of brief advice would show whether this is the case. To find out whether this is feasible, this study aims to find out how many patients could be invited and agree to take part in a study like this, how many would stay involved with the study, and whether they would find it practical and acceptable.

Who can participate?
Patients aged 18 and over and registered with GPs in the North East of England can take part if they are drinking alcohol over the UK recommended levels (21 units per week for men, 14 units per week for women) and are either diagnosed as hypertensive (high blood pressure) or have had mild to moderate depression or low mood.

What does the study involve?
The study involves filling in a questionnaire about alcohol and posting it back to the research team. If you choose to supply contact details on the questionnaire, a researcher will then contact you to arrange a 15-20 minute meeting at your GP surgery. At the meeting, the researcher will either measure your blood pressure using a standard cuff or ask a few questions about your mood. Participants will be randomly allocated to a control or an intervention group. Participants in the control group will receive a leaflet on high blood pressure or depression to take home. Intervention group participants will receive the same leaflets as the control group and the researcher may also briefly offer some advice about alcohol consumption and health. After 6 months you will be asked to meet again with the researcher at your GP surgery for 15 minutes to measure your blood pressure or ask questions about your mood, and to ask a few more questions about your alcohol consumption. This should take no longer than 15 minutes.

What are the possible benefits and risks of participating?
If you take part you will receive confidential advice on whether the amount you are drinking could be a risk to your health, as well as information about links between alcohol consumption and your condition (hypertension or depression) and how to reduce drinking to levels of low risk to health.
There are no anticipated risks involved in taking part. Any information about you which leaves the GP surgery will have your name and address removed.

Where is the study run from?
Study is coordinated by North Tyneside Primary Care Trust. The study will be run from GP surgeries in the North East of England.

When is the study starting and how long is it expected to run for?
The study started in August 2010 and ran until February 2012.

Who is funding the study?
North Tyneside NHS Primary Care Trust, UK.

Who is the main contact?
Dr Graeme Wilson, Project manager, Newcastle University

Contact information

Prof Eileen Kaner
Scientific

Institute of Health & Society
Newcastle University
Baddiley Clark Building
Richardson Road
Newcastle Upon Tyne
NE2 4AX
United Kingdom

Email	eileen.kaner@newcastle.ac.uk

Study information

Primary study design	Interventional
Study design	Two parallel two-arm cluster randomised controlled pilot trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Feasibility trial of brief intervention to improve alcohol consumption and Co-morBId outcomes in primary care patients with hypertension or mild to moderate depression
Study acronym	ComBIne
Study objectives	The study aim is to investigate the feasibility of conducting larger future trials exploring brief intervention in primary care for heavy drinkers with co-morbid hypertension or depression.
Ethics approval(s)	County Durham and Tees Valley NHS Research Ethics Committee, 23/07/2010, REC Reference Number 10/H0908/35
Health condition(s) or problem(s) studied	Excessive alcohol drinking with co-morbid hypertension or mild to moderate depression
Intervention	1. In control arm, patients receive either an advice leaflet produced by the British Heart Foundation (hypertension trial) or a leaflet on depression produced by a regional NHS organisation (depression trial). 2. In intervention arm, participants receive the same leaflets as in the control arm plus a brief intervention involving a single practice-based 10 minute session of structured advice about reducing alcohol consumption levels, delivered by a trained research worker.
Intervention type	Other
Primary outcome measure(s)	1. Rates of eligibility for the trial 2. Recruitment Eligibility and recruitment of participants are recorded on the trial database at entry to the study; frequencies for each of these are calculated as a proportion of patients screened to give the outcome measures. 3. Retention Retention of the participants in the trial is recorded on the database at the six-month follow-up; frequencies are calculated as a proportion of patients recruited to give this outcome measure.
Key secondary outcome measure(s)	1. Score on Alcohol Use Disorder Identification Tool (AUDIT) 2. Systolic and diastolic blood pressure (hypertension trial) 3. Score on Patient Health Questionnaire (PHQ-9, depression trial) 4. Acceptability of trial instruments and procedures Each of these is measured at the baseline appointment, then again at the six month follow up appointment.
Completion date	29/02/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	120
Key inclusion criteria	1. Male or female primary care patients 2. Aged 18 and over 3. Either diagnosed as hypertensive or with mild to moderate depression (scoring 5-19 inclusive on PHQ-9) 4. Drinking alcohol over the UK recommended levels of 21 units per week for men or 14 units per week for women
Key exclusion criteria	1. Under the age of 18 2. Cognitive impairment 3. Terminal illness 4. Severe depression or mental health problems 5. Accessing treatment for alcohol misuse
Date of first enrolment	01/08/2010
Date of final enrolment	29/02/2012

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Institute of Health & Society

Newcastle Upon Tyne
NE2 4AX
United Kingdom

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/06/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes