The primary objective is to test whether adding online CBM Avoid Alcohol training (compared to a placebo training) to a web-based cognitive behavioral treatment (TAU) has an added effect on decreasing weekly alcohol consumption in problem drinkers.…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
probleemdrinkers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the percentage of participants reporting alcohol
consumption below problem drinking limits (<22 standard units/week for men and
<15 for women).
Secondary outcome
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 level, employment, alcohol dependence, and treatment motivation. We
will also assess the number of completed sessions and TAU sessions.
Type and severity of alcohol dependence at baseline will be assessed by using
the DSM-IV, by means of the Substance Abuse Module of the Composite
International Diagnostic Interview (Compton et al., 1996).
Baseline Drinking Motives will be measured with the modified Drinking Motives
Questionnaire Revised (mDMQ-R, Cooper, 1994). The mDMQ-R is a 28-item
self-report inventory that assessed the relative frequency of drinking for each
of the four motives in Cooper*s (1994) model. Participants indicate their
relative frequency of alcohol use for each of the listed reasons on a scale
ranging from 1 (almost never/never) to 5 (almost always/always).
The 5-item Obsessive Compulsive Drinking Scale (OCDS) is derived from the
original 14-item OCDS scale. The OCDS reflects obsessionality and compulsivity
related to craving and drinking behavior (Anton et al., 1995).
Drinking Refusal Self-efficacy (Oei et al., 2005) will be assessed with 8 items
covering all 3 subdimensions of self-efficacy: social pressure, emotional
relief, and opportunistic. Drinking refusal self-efficacy is considered an
important cognitive mechanism within the reflective system that predicts
treatment outcome. We hypothesize that when baseline self-efficacy is low, the
additional effect of the CBM Avoid Alcohol training will be stronger.
Additionally, time-varying self-efficacy is expected to mediate the CBM effect
as repeated experiences of successful coping due to stronger avoidance
responses will enhance refusal self-efficacy.
Credibility of the CBM training will be assessed with the Credibility and
Expectancy Questionnaire (CEQ, Devilly & Borkovec, 2000). Directly after the
first session of training, participants complete this questionnaire It contains
six items and differentiates between one*s thoughts and feelings regarding the
CBM training.
Client Satisfaction regarding the CBM training will be assessed with the Client
Satisfaction Questionnaire (CSQ; de Brey, 1983).The questionnaire contains 8
items and answers are given on a 4-point scale.
Background summary
Recent theoretical models emphasize the role of automatic processes in alcohol
addiction. A new development is Cognitive Bias Modification (CBM) training; a
computerised training program specifically designed to reduce automatic biases
in information processing with the aim of reducing problematic drinking. The
aim of the current study is to examine the effectiveness of the training as an
adjunct to treatment as usual (TAU) in an outpatient web-based treatment
setting in the Netherlands.
Study objective
The primary objective is to test whether adding online CBM Avoid Alcohol
training (compared to a placebo training) to a web-based cognitive behavioral
treatment (TAU) has an added effect on decreasing weekly alcohol consumption in
problem drinkers. Secondary objectives are investigating 1) generalization to
health status, quality of life, depression, anxiety and stress; 2) whether the
added effect on treatment outcome is mediated by the amount of change in
approach-bias; 3) who benefits most from training (testing moderation), and 4)
testing adherence, acceptability, and credibility.
Study design
It is a double-blind placebo controlled intervention study with pre- and
post-assessments and two follow-up assessments (three and six months follow
up).
Intervention
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 participants receive pictures
of alcoholic beverages and soda drinks, that are tilted to the left or right.
All participants are instructed to approach one type of tilt (e.g., tilted
left) by pushing a certain key (and the picture grows bigger) and avoid to
other type of tilt (e.g., tilted right) by another key (and the picture
shrinks). Participants in the CBM Avoid Alcohol training proved to avoid mostly
alcoholic pictures and approached most soda drinks, while participants in the
placebo training approached and avoided those pictures equally often.
The training consists of a pre- and postassessment (with 160 pictures per
assessment) and 8 training sessions (with 192 pictures per session).
Study burden and risks
With regard to risks associated with participation, it is highly unlikely that
participants will suffer any negative consequences of the CBM training or
placebo-training. CBM training involves a simple computerized performance task,
that is non-invasive, requires little cognitive effort, and does not affect the
personal integrity of participants. With regard to the burden involved,
participants are required to do 2 CBM sessions weekly during 5 weeks, and
participants have to fill in questionnaires that will take approximately 45
minutes in total (spread over 4 measurements).
Participation will benefit participants in both groups as the TAU
Alcoholdebaas.nl has been shown an evidence based treatment for problem
drinking. The expected benefit of the additional CBM training is in the first
place a higher likelihood of achieving a safe alcohol consumption level.
The medical risks, like severe withdrawal symptoms are controlled in the TAU
according to a protocol. Following the protocol, the TAU starts after the
general practitioner has given consent to participate by completing a referral
note. During treatment medical and acute risks are closely monitored by the
individual social worker. If necessary the social worker contact the general
practitioner. When participants, after finishing the first diagnostic part of
the TAU, start to drink less or stop drinking, a multidisciplinary team decides
whether the participant may start with these behavior. If there is a risk of
withdrawal symptoms, the access to part 2 is denied. The participant will then
be referred to the general practitioner for medical assistance or will be
advised to follow another more appropriate form of treatment.
Weesperplein 4
Amsterdam 1018 XA
NL
Weesperplein 4
Amsterdam 1018 XA
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL48563.018.14 |
OMON | NL-OMON24326 |