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A randomized, controlled trial on the added value of online cognitive bias modification avoid-alcohol training (CBM AAT) on web-based cognitive behavioural treatment (TAU) for problem drinkers

A randomized, controlled trial on the added value of online cognitive bias modification avoid-alcohol training (CBM AAT) on web-based cognitive behavioural treatment (TAU) for problem drinkers - Web-based treatment + CBM avoid alcohol training

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42123
Enrollment
304
Registered
2015-02-17
Start date
2015-06-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

probleemdrinkers alcohol use problems problem drinkers

Interventions

The Web-based TAU consists of a structured, online CBT program in which the participant and the therapist communicate asynchronously, via the Internet only. Regarding CBM Avoid Alcohol training, all

Sponsors

Universiteit van Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All patients who will be treated in the web-based TAU, have indicated themselves that they have an alcohol problem and can be included in the study. Since patients access the web-based TAU and CBM training at home online, it is essential that they have an internet connection. Good command of the Dutch language is also needed; Dutch as first language is therefore also an inclusion criterion.

Exclusion criteria

Exclusion criteria: There are no additional exclusion criteria on top of the criteria that Tactus applies for participation in the web-based TAU. These exclusion criteria are: (1) serious psychiatric illnesses with a chance to decompensate while decreasing alcohol consumption; (2) a chance of severe physical illnesses as a consequence of decreasing alcohol consumption. behavior.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the percentage of participants reporting alcohol consumption below problem drinking limits (

Secondary

MeasureTime frame
Health status will be assessed with the Maudsley Addiction Profile, Health Symptom Scale (MAP-HSS). The MAP-HSS is a ten-item structured interview, which was adapted from the health scale of the Opiate Treatment Index (Marsden et al., 1998). Quality of life will be measured with the EuroQol-5D (EQ-5D) (Lamers et al., 2005). The EuroQol-5D is a generic quality-of-life (QoL) instrument which consists of 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. In addition, participants were asked to rate quality of life in the last week, in comparison with last year, by means of a visual analogue scale (VAS). Depression, anxiety and stress will be measured with the 21-item Depression Anxiety Stress Scale (DASS-21) (Antony et al., 1998). Approach-bias: Approach-bias is measured with an AAT (Wiers et al., 2009), ), in the pre-assessment and post-assessment. The assessment AAT will begin with 12 practice pictures in which participants learn to avoid or approach the picture in response to the tilt of the picture (tilted left or right). The practice phase will be followed by the pre-assessment, consisting of 160 test pictures in which pictures of alcoholic drinks and non-alcoholic drinks come equally often in push- or pullformat (e.g. tilted left and right). To control for confounding by left-right preferences picture format will be counterbalanced, with half the participants pulling pictures tilted to the left and half pulling pictures tilted to the right. An AAT bias index is calculated as the difference between the median reaction time scores for pushing pictures of one category (alcohol or soft drinks) and the median reaction time score for pulling pictures of that category. Median scores are used to minimize the influence of outliers. Positive scores indicate approach tendencies and negative scores indicate avoidance tendencies. Background variables that will be assessed at baseline are gender, age, education

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)