Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
11/03/2009
Prospective/Retrospective
Retrospectively 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

Dr H. Riper

ORCID ID

Contact details

Trimbos-instituut
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 297 1100
hriper@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR131

Study information

Scientific title

'Drinking Less' - an online self-help intervention for problem drinkers in the general population: results from an online randomised clinical trial

Acronym

'Drinking Less'

Study hypothesis

We tested the hypothesis of the superior effectiveness of an online preventive self help intervention for problem drinkers based on cognitive-behavioural self control principles vis-à-vis an online psycho-education brochure for problem drinkers.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Alcohol abuse, alcoholism

Intervention

The experimental condition received the 'Drinking Less' intervention. 'Drinking Less' is a web-based self help intervention for problem drinkers who want to reduce their alcohol consumption without any direct professional guidance. It is based on cognitive-behavioural self control principles. The program consists of four phases:
1. Preparation
2. Decision and goal setting
3. Conduct
4. Maintenance

The intervention provides support to problem drinkers through techniques such as a monitoring log book, educational information and exercises. It also allows different participants to exchange information and experiences with one another through an internet forum. Participants are advised to use the intervention for a period of six weeks.

The control group received access to a brief web-based alcohol information brochure in which the impact of alcohol on body, mind and functioning and the limits for safe alcohol consumption are discussed.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Mean weekly alcohol consumption: number of units (10 g pure alcohol) in the past 7 days
2. Proportion of subjects not at-risk, i.e. drinking 21 units or less a week (men) and 14 units or less a week (women)
3. Proportion of subjects not drinking hazardously: i.e., not drinking more than 5 units (men) or 3 units (women) on any day a week in the past three months
4. Proportion of subjects not drinking at risk and/or hazardously (as defined under 2 and 3)
5. Proportion of subjects not drinking at risk and/or hazardously (as defined under 4) and who do not experience alcohol related problems

Secondary outcome measures

1. Quality of life
2. Psychological well being
3. Satisfaction with the interventions

Overall trial start date

01/06/2003

Overall trial end date

31/10/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were eligible to participate if they were between 18 and 65 years of age, had a weekly alcohol consumption of more than 21 units (greater than or equal to 210 g - men) or more than 14 units (greater than or equal to 140 g - women) and or who were consuming more than 5 units of alcohol (greater than or equal to 50 g - men) or 3 units of alcohol (greater than or equal to 30 g - women) on one or more days a week in the past three months and who had access to a computer and internet.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

268

Participant exclusion criteria

1. Participants who received professional help
2. Participated in a self help group and/or medication for their drinking problems (last year)
3. Participated in a conflicting scientific study

Recruitment start date

01/06/2003

Recruitment end date

31/10/2004

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos-instituut
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos Institute - Netherlands Institute of Mental Health and Addiction (Netherlands)

Sponsor details

Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 297 1100
info@trimbos.nl

Sponsor type

Research organisation

Website

http://www.trimbos.nl/default2.html

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

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

Publication citations

Additional files

Editorial Notes