Condition category
Mental and Behavioural Disorders
Date applied
03/03/2008
Date assigned
04/04/2008
Last edited
03/01/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.alcoholdebaas.nl/onderzoek

Contact information

Type

Scientific

Primary contact

Mrs Marloes Postel

ORCID ID

Contact details

Institutenweg 1
Enschede
7521 PH
Netherlands
+31 (0)53 4824750
m.postel@tactus.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The research questions of this study are:
1. Is an internet based therapy with therapist involvement, based on cognitive behaviour therapy, effective in terms of reducing alcohol consumption and improvement of health status?
2. Do patient's characteristics such as demographics, drinking amount, severity of health problems, motivation for treatment, and readiness to change, have predictive value on the effectiveness of the e-therapy?

Ethics approval

Ethics board METiGG (Medisch-Ethische Toetsingscommissie instellingen Geestelijke Gezondheidszorg, kamer Zuid). Date of approval: 30/01/2008. (CCMO number: NL20742.097.07, protocol number 7.133)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

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

Condition

Problem drinking

Intervention

Method of randomisation: Automatically by computer (according to a computer generated random list), in blocks of eight.

Experimental group: The E-therapy program (www.alcoholdebaas.nl) consists of an informational website with an online cognitieve behavioural counselling program for problem drinkers. The aim of the E-therapy program is to motivate the patient to change their drinking habits with the ultimate goal of reducing or stopping alcohol intake. Phase 1 of the program consists of four assignments focusing on the analysis of the participants drinking habits. A personal advice is given at the end. Phase 2 consists of five assignments; the patient sets a goal to quit drinking or reduce drinking, and in four steps learns to reach this goal. The experimental group receives treatment immediately after randomization. Treatment will last for 3 months.

Control group: The waiting list control group receives an email from a therapist every two weeks. The messages involve alcohol related information, psycho-education, motivational messages or references to the website or the forum. The control group will receive the E-therapy intervention immediately after completion of the experimental group (approximately 3 months after randomization).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Mean weekly alcohol consumption in standard units a week (weekly recall)
2. Proportion of patients achieving their drinking goal (abstinence or moderate drinking)
3. Proportion of subjects not at risk (drinking 21 units or less for men and 14 units or less for women)

Timepoints of assessment:
E = Experimental group
C = Control group

T0: Baseline (E and C)
T1: Post-treatment (E) and pre-intervention (C)
T2: 3 months after T1 (E) and post treatment (C)
T3: 6 months after T1 (E) and 3 months after T2 (C)
T4: 9 months after T1 (E) and 6 months after T2 (C)

Secondary outcome measures

1. Alcohol related problems, assessed by the Maudsley Addiction Profile – Health Symptom Scale (MAP-HSS)
2. Health status, assessed by the 28-item General Health Questionnaire (GHQ)
3. Quality of life, assessed by the 5-item EuroQol-5D
4. Satisfaction

Timepoints of assessment:
E = Experimental group
C = Control group

T0: Baseline (E and C)
T1: Post-treatment (E) and pre-intervention (C)
T2: 3 months after T1 (E) and post treatment (C)
T3: 6 months after T1 (E) and 3 months after T2 (C)
T4: 9 months after T1 (E) and 6 months after T2 (C)

Overall trial start date

01/06/2008

Overall trial end date

01/08/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Minimum age of 18
2. Minimum drinking amount of 14 (females) or 21 (males) standard units a week
3. Able to read and write in Dutch
4. Given informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Receiving professional help for their drinking problem
2. Severe physical or psychiatric illness
3. Treatment or medication for psychiatric illnesses during the past six months

Recruitment start date

01/06/2008

Recruitment end date

01/08/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Institutenweg 1
Enschede
7521 PH
Netherlands

Sponsor information

Organisation

Tactus Addiction Care Centre (The Netherlands)

Sponsor details

Institutenweg 1
Enschede
7521 PH
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.tactus.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Tactus Addiction Care Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nijmegen Institute of Scientific Practitioners in Addiction (NISPA) (The 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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/22201703

Publication citations

  1. Results

    Postel MG, de Haan HA, ter Huurne ED, van der Palen J, Becker ES, de Jong CA, Attrition in web-based treatment for problem drinkers., J. Med. Internet Res., 2011, 13, 4, e117, doi: 10.2196/jmir.1811.

Additional files

Editorial Notes