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Avoid alcohol training in treatment for problem drinkers


- candidate number21780
- NTR NumberNTR5087
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-mrt-2015
- Secondary IDsNL48563.018.14 MEC Academisch Medisch Centrum Amsterdam
- Public TitleAvoid alcohol training in treatment for problem drinkers
- Scientific TitleThe effectiveness of CBM Avoid Alcohol training as an adjunct to cognitive behavioral treatment (TAU) in an outpatient treatment setting in reducing alcohol abuse
- ACRONYMCBM-AAT +CBT
- hypothesis1. A higher percentage of participants reaching the guidelines for low risk drinking in the AAT training condition compared to those in the AAT placebo condition.
2. Improvement of health status, quality of life, and depression, anxiety and stress symptoms in participants in the AAT training condition compared to those in the placebo condition.
3.The added effect on treatment outcome is mediated by a change in approach bias.
- Healt Condition(s) or Problem(s) studiedAlcohol abuse
- Inclusion criteria- Participants follow cognitive behavioral
treatment for alcohol abuse.
- Dutch as first language
- Exclusion criteria- There are no exclusion criteria in order to participate in this trial.

For participation in the web- based treatment:
- Age 18
- Serious psychiatric illnesses with a chance to decompensate while decreasing alcohol consumption.
- A chance of severe physical illnesses as a consequence of decreasing alcohol consumption behavior.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 13-mei-2015
- planned closingdate13-mei-2017
- Target number of participants304
- InterventionsThe CBM training will start simultaneously with the goal setting assignment in the TAU (web-based treatment or face-to face treatment for alcohol abuse).
The training consists of a pre- and postassessment and 8 training sessions.
Condition 1: TAU + AAT training
Condition 2: TAU + placebo AAT
- Primary outcomeProportion of participants reaching the guidelines for low risk drinking (<22 standard units/week for men and <15 for women).
- Secondary outcome-To investigate whether adding online CBM Avoid Alcohol training to a web-based TAU improves health status(MAP-HSS) and quality of life (EQ-5D), and decreases depression, anxiety and stress (DASS-21) when compared to TAU + placebo training.
-Whether the added effect on treatment outcome is mediated by the amount of change in approach-bias (AAT).
-Investigate who benefits most from training.
-To what extent clients adhere to the CBM Avoid Alcohol training and to what extent they find the CBM Avoid Alcohol training acceptable and credible (CEQ, CSQ).
- Timepoints-Intake procedure Treatment as usual (demographic characteristics, TLFB, MAP- HSS, DASS-21, EQ-5D, 5-items OCDS, CIDI)
-Pre-assessment training (TLFB, VAS, DMQ-r, Drinking refusal self-efficacy, AAT)
-Post-assessment training (TLFB, VAS, AAT and CSQ)
-Posttest and follow-up Treatment as usual (TLFB, MAP-HSS, DASS-21, EQ-5D, 5-items OCDS)
- Trial web sitewww.alcoholdebaas.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Melissa Laurens
- CONTACT for SCIENTIFIC QUERIESDr. E. Salemink
- Sponsor/Initiator Saxion University of Applied Sciences Academie Mens & Maatschappij, University of Amsterdam (UvA), University of Twente, Tactus Addiction Treatment
- Funding
(Source(s) of Monetary or Material Support)
NWO Veni, Promotion funds Saxion University of Applied Sciences, University of Twente, University of Amsterdam, Tactus Addiction Treatment
- Publications
- Brief summaryThe aim of the study is to examine the effectiveness of CBM Avoid Alcohol training as an adjunct to a cognitive behavioral treatment (TAU) in an outpatient treatment setting. The TAU consists of a structured, online CBT program in which the participant and the therapist communicate asynchronously, via the Internet only or a face-to-face CBT group or individual therapy. A treatment regarding CBM Avoid Alcohol training is added to the TAU. Patients will be randomised to a CBM Avoid Alcohol training or to a CBM placebo training. All participants receive pictures of alcoholic beverages and soda drinks, that are tilted to the left or right. They are instructed to approach one type of tilt (e.g., tilted left) by pushing a certain key (and the picture grows bigger) and avoid the other type of tilt (e.g., tilted right) by another key (and the picture shrinks). Participants in the experimental group (AAT-training) avoid alcoholic pictures and approach soda drinks, while participants in the control group (placebo training) approach and avoid those pictures equally often.
- Main changes (audit trail)22-mei-2015:
Hypothesis changed:
2. Improvement of health status and depression, anxiety and stress symptoms in participants in the AAT training condition compared to those in the placebo condition.

Secondary outcome changed:
To investigate whether adding online CBM Avoid Alcohol training to cognitive behavioral treatment (TAU) improves health status (MAP- HSS) and decreases depression, anxiety and stress (DASS-21) when compared to TAU + placebo training.

Timepoints changed:
- Intake procedure Treatment as usual (demographic characteristics, TLFB, MAP-HSS, DASS-21, 5-items OCDS, CIDI)
- Pre-assessment training (TLFB, VAS, DMQ-r, Drinking refusal self-efficacy, AAT)
- Post- assessment training (TLFB, VAS, AAT and CSQ)
- Posttest and follow-up Treatment as usual (TLFB, MAP-HSS, DASS-21, 5-items OCDS)
- RECORD10-mrt-2015 - 11-sep-2017


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