Condition category
Mental and Behavioural Disorders
Date applied
29/10/2010
Date assigned
25/11/2010
Last edited
25/11/2010
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 Peter Tossmann

ORCID ID

Contact details

Behaimstr. 20
Berlin
10585
Germany
tossmann@delphi-gesellschaft.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of an internet-based one-time counselling intervention for young cannabis- or alcohol-users: an online randomised controlled trial

Acronym

Study hypothesis

A one-time professional chat-based intervention for problematic cannabis- and alcohol-users is more effective than a chat-based interaction solely dealing with general addiction issues.

Ethics approval

Ethics committee of the University of Applied Sciences Magdeburg approved on the 9th September 2010 (ref: AZ-4973-14)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Can be found at http://www.drugcom.de/chatstudieninfo.pdf

Condition

Alcohol abuse or addicition, cannabis abuse or addicition

Intervention

Participants in the experimental condition receive a one-time brief intervention delivered via internet-chat. During the intervention, Motivational Interviewing (MI) is applied by trained psychologists.

Participants in the control condition receive information about addiction in general and about the results in the self-test.

Each arm involves a one-time chat-based intervention with a duration of approximately 30 minutes, with follow-up online surveys at one month and three months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Alcohol users:
1. Mean weekly alcohol consumption: consumed amount of pure alcohol in the past 7 days
2. Mean number of consumption days in the past 30 days
3. Proportion of subjects not drinking hazardously: i.e., not drinking more than 24 grams of pure alcohol (men) or 12 grams (women) on any day during the last week

Cannabis users:
4. Mean number of consumption days in the past 30 days

Both alcohol and cannabis users:
5. Allocation on the Stages of Change (Transtheoretical Model) measured by the "Readiness to Change Questionnaire" (RTCQ)

Measured using follow-up online surveys at one month and three months.

Secondary outcome measures

Satisfaction with the received intervention, measured using follow-up online surveys at one month and three months.

Overall trial start date

30/09/2010

Overall trial end date

31/03/2011

Reason abandoned

Eligibility

Participant inclusion criteria

The study aims at participants of two automated internet-based self-tests for cannabis- or alcohol-users installed on the prevention website www.drugcom.de. In order to be eligible for the study, those users have to meet the following criteria:
1. Problematic alcohol use defined as:
1.1. Alcohol Use Disorders Identification Test (AUDIT) score of 16 or more, or
1.2. Alcohol consumption of more than 60 g per day (men)/40 g per day (women), or
1.3. Binge drinking (i.e. at least 5 units of alcohol per occasion) at least once per week
2. Problematic cannabis use defined as 4 or more points in the Severity of Dependence Scale (SDS) (men) or 2 points or more (women)
3. Aged 18 - 35 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

194

Participant exclusion criteria

Participants who currently receive professional help or participate at a self help group.

Recruitment start date

30/09/2010

Recruitment end date

31/03/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Behaimstr. 20
Berlin
10585
Germany

Sponsor information

Organisation

Federal Centre for Health Education (BZgA) (Germany)

Sponsor details

Ostmerheimer Str. 200
Cologne
51109
Germany

Sponsor type

Government

Website

http://www.bzga.de

Funders

Funder type

Government

Funder name

Federal Centre for Health Education (BZgA) (Germany)

Alternative name(s)

Federal Centre for Health Education, BZgA

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

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