Randomised controlled trial on the effectiveness of an E-therapy program for problem drinkers
ISRCTN | ISRCTN39104853 |
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DOI | https://doi.org/10.1186/ISRCTN39104853 |
Secondary identifying numbers | N/A |
- Submission date
- 03/03/2008
- Registration date
- 04/04/2008
- Last edited
- 03/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Marloes Postel
Scientific
Scientific
Institutenweg 1
Enschede
7521 PH
Netherlands
Phone | +31 (0)53 4824750 |
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m.postel@tactus.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study objectives | 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(s) | 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) |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | 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 study start date | 01/06/2008 |
Completion date | 01/08/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 150 |
Key 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 |
Key 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 |
Date of first enrolment | 01/06/2008 |
Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Institutenweg 1
Enschede
7521 PH
Netherlands
7521 PH
Netherlands
Sponsor information
Tactus Addiction Care Centre (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Institutenweg 1
Enschede
7521 PH
Netherlands
Website | http://www.tactus.nl |
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https://ror.org/00v0vvh64 |
Funders
Funder type
Hospital/treatment centre
Tactus Addiction Care Centre (The Netherlands)
No information available
Nijmegen Institute of Scientific Practitioners in Addiction (NISPA) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 27/12/2011 | Yes | No |