Condition category
Mental and Behavioural Disorders
Date applied
23/08/2013
Date assigned
21/10/2013
Last edited
30/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eileen Kaner

ORCID ID

Contact details

Institute of Health & Society
Newcastle University
Baddiley Clark Building
Richardson Road
Newcastle Upon Tyne
NE2 4AX
United Kingdom
eileen.kaner@newcastle.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10SUBM001

Study information

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

Acronym

ComBIne

Study hypothesis

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

County Durham and Tees Valley NHS Research Ethics Committee, 23/07/2010, REC Reference Number 10/H0908/35

Study design

Two parallel two-arm cluster randomised controlled pilot trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/08/2010

Overall trial end date

29/02/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/08/2010

Recruitment end date

29/02/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health & Society
Newcastle Upon Tyne
NE2 4AX
United Kingdom

Sponsor information

Organisation

North Tyneside Primary Care Trust (UK)

Sponsor details

NHS North of Tyne
Bevan House
1 Esh Plaza
Great Park
Newcastle upon Tyne
NE13 9BA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

North Tyneside NHS Primary Care Trust (UK)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24947447

Publication citations

  1. Results

    Wilson GB, Wray C, McGovern R, Newbury-Birch D, McColl E, Crosland A, Speed C, Cassidy P, Tomson D, Haining S, Howel D, Kaner EF, Intervention to reduce excessive alcohol consumption and improve comorbidity outcomes in hypertensive or depressed primary care patients: two parallel cluster randomized feasibility trials., Trials, 2014, 15, 235, doi: 10.1186/1745-6215-15-235.

Additional files

Editorial Notes