Randomised controlled trial on the effectiveness of an E-therapy program for problem drinkers

ISRCTN	ISRCTN39104853
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

Study website

Contact information

Mrs Marloes Postel
Scientific

Institutenweg 1
Enschede
7521 PH
Netherlands

Phone	+31 (0)53 4824750
Email	m.postel@tactus.nl

Study information

Study design	Randomised controlled trial
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
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

Sponsor information

Tactus Addiction Care Centre (The Netherlands)
Hospital/treatment centre

Institutenweg 1
Enschede
7521 PH
Netherlands

Website	http://www.tactus.nl
"ROR"	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
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?
Results article	results	27/12/2011		Yes	No