Condition category
Mental and Behavioural Disorders
Date applied
28/01/2008
Date assigned
29/01/2008
Last edited
13/03/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof David Leon

ORCID ID

Contact details

London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2252
david.leon@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

078557

Study information

Scientific title

Randomised controlled trial of motivational interviewing to reduce hazardous drinking among Russian working-age men

Acronym

HIM

Study hypothesis

The study is a trial to explore the efficacy and acceptability of a brief intervention aimed at reducing the prevalence of hazardous drinking in working age men in a typical Russian city (Izhevsk).

Hypothesis:
A brief adaptation of motivational interviewing will be effective in reducing self-reported hazardous drinking at 3 months.

Ethics approval

Ethics approval received from the London School of Hygiene and Tropical Medicine Ethics Committee on the 16th January 2008 (ref: 5230).

Study design

The study will be an individually randomised, two-armed parallel group, single centre exploratory trial

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

Hazardous drinking

Intervention

An adaptation of Motivational Interviewing (MI) has been developed for the Russian context, and includes topics such as surrogate drinking and binge drinking (zapoi). MI involves empathic questioning and listening, with a view to the development of discrepancy between alcohol use and other goals and values and the eliciting of personalised statements about change. The full intervention comprises up to four sessions. These will be delivered at home or in a clinic by specially trained practitioners.

The control group will not receive any intervention other than having a health check as part of the longitudinal study and being invited for 3 and 12 months follow-up.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

SELF report of hazardous drinking 3 months post-randomisation defined as one or more occurrences of:
1. Binge drinking (zapoi) in the past month
2. Surrogates in the past month
3. Hangover and/or excessive drunkenness and/or going to sleep clothed due to being drunk twice or more per week on average over the past month
4. 250 mls or more of ethanol from beverages in the past week from beverages (i.e., 25+ UK alcohol units)

Secondary outcome measures

SELF and PROXY report of hazardous drinking 12 months post-randomisation defined as one or more occurrences of:
1. Binge drinking (zapoi) in the past month
2. Surrogates in the past month
3. Hangover and/or excessive drunkenness and/or going to sleep clothed due to being drunk twice or more per week on average over the past month
4. 250 mls or more of ethanol from beverages in the past week from beverages (i.e., 25+ UK alcohol units)

SELF completed:
5. AUDIT questionnaire (World Health Organization [WHO] developed global screening assessment of hazardous drinking
6. Leeds Dependency questionnaire
7. Short Index of Problems (SIP) questionnaire

Biomarkers of:
9. Liver damage (gamma-glutamyl transferase [GGT], alanine aminotransferase [ALT], aspartate aminotransferase [AST])
10. Recent heavy drinking (carbohydrate-deficient transferrin [CDT])

Overall trial start date

01/02/2008

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

The men recruited into the trial will be drawn from a longitudinal observational study that is part of the Izhevsk Family Study II (aged 27 - 54 years).

PROXY reports (or self reports for men living alone) of hazardous drinking defined as one or more occurrences of:
1. Binge drinking in the past year
2. Surrogates in the past year
3. Hangover and/or excessive drunkenness and/or going to sleep clothed due to being drunk twice or more per week on average over the past year
4. Weekly average of 250 mls or more of ethanol from beverages over the past year (i.e., 25+ UK alcohol units/week)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

250 participants

Participant exclusion criteria

1. Refusal to have a baseline health check
2. Refusal to be followed up at 3 and 12 months

Either of these criteria will result in exclusion from the trial.

Recruitment start date

01/02/2008

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Russian Federation

Trial participating centre

London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 078557)

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

1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18377650
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22053775

Publication citations

  1. Protocol

    Tomkins S, Allen E, Savenko O, McCambridge J, Saburova L, Kiryanov N, Oralov A, Gil A, Leon DA, McKee M, Elbourne D, The HIM (Health for Izhevsk Men) trial protocol., BMC Health Serv Res, 2008, 8, 69, doi: 10.1186/1472-6963-8-69.

  2. Results

    Allen E, Polikina O, Saburova L, McCambridge J, Elbourne D, Pakriev S, Nekrasova N, Vasilyev M, Tomlin K, Oralov A, Gil A, McKee M, Kiryanov N, Leon DA, The efficacy of a brief intervention in reducing hazardous drinking in working age men in Russia: the HIM (Health for Izhevsk men) individually randomised parallel group exploratory trial., Trials, 2011, 12, 238, doi: 10.1186/1745-6215-12-238.

Additional files

Editorial Notes