Plain English Summary
Not provided at time of registration
Trial website
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
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
-
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.