The aims of the present study are: (1) to assess for the first time in the Netherlands the effectiveness of an adjunctive Alcohol Avoidance Training (AAT) during inpatient alcohol detoxification to improve treatment outcomes. (2) To investigate for…
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Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome variable of this study will be alcohol abstinence at
two-weeks, three- and six-months post-training. Outcomes will be assessed in a
telephonic follow-up interview, there will be asked the same questions as in
the computerised assessments before and after the AAT training sessions.
Secondary outcome
Secondary outcome variables are changes in craving, potential relapse (how much
alcohol was consumed?) and psychological complaints.
Further, AAT expectations will be assessed at the start of AAT and evaluation
(acceptability and feasibility).
Background summary
Alcohol addiction is a common disorder in the Netherlands, with 0.7% of the
Dutch people meeting the criteria of an alcohol addiction (965.331 persons, 15
years or older, ICD-10, WHO, 2014).
Nowadays, the treatment of addiction in the Netherlands is primarily
directed towards Cognitive Behavioural Therapy (CBT). This treatment targets
the conscious cognitive processes which might be a possible reason of the
limited success rates (Heitmann et.al., 2017). Dual process models became
increasingly important in the explanation and treatment of addiction problems.
It assumes that addictive behaviours are characterized by an imbalance between
two independent but interacting information processing systems (Bechara, 2005,
Stacy & Wiers, 2010, Manning, 2016), namely the impulsive and the
reflective/executive system. The hypothetical imbalance between impulsive and
reflective processes has been related to a number of cognitive biases (Wiers et
al, 2013). These cognitive biases include an attentional bias (the tendency for
alcohol-related cues in the environment to selectively capture attention) for
alcohol-related stimuli (Field & Cox, 2008), a memory bias for the automatic
activation of alcohol-related associations (Wiers, Van Woerden, Smulders, & De
Jong, 2002), and a bias toward automatically activated action tendencies to
approach alcohol (Palfai & Ostafin, 2003).
Cognitive Bias Modification (CBM) is a new training method to target
these cognitive biases (Wiers et al., 2013). Wiers and colleagues developed the
alcohol approach/avoidance task (Alcohol-AAT) to assess a potential bias in the
action tendency to approach (versus avoid) alcohol stimuli (Wiers, Rinck,
Dictus, & Van den Wildenberg, 2009). The use of alcohol-AAT in the treatment of
alcohol-addicted participants has proven to be effective in reducing alcohol
relapse in Germany and Australia (Manning et al., 2016, Eberl et al., 2013,
Wiers et al, 2011).
In his Australian study, Manning concludes that detoxification could be a
potential critical time to modify approach bias (Manning et al., 2016). Patient
detoxification may be an opportunity to capitalize on neural recovery via
neurocognitive interventions that retrain cognitive biases (Manning et al.,
2016). If confirmed, one reason could be that this early period of abstinence
from alcohol is a particularly high-risk time for relapse. Studies reporting
that 50 to 80% of addicted drinkers resume drinking following detoxification
(Garbusow et al., 2014; Miller and Kavanagh, 2011; Sanghani et al., 2015),
often within the first few days or weeks (De Wilde et al., 2014; Miller and
Kavanagh, 2011). Summarizing: the results that are achieved in previous CBM
studies with an AAT low-cost adjunctive treatment are promising, and more
research is highly desirable.
Study objective
The aims of the present study are: (1) to assess for the first time in the
Netherlands the effectiveness of an adjunctive Alcohol Avoidance Training (AAT)
during inpatient alcohol detoxification to improve treatment outcomes. (2) To
investigate for the first time in Europe if the timing of the training is
distinctive comparing AAT during inpatient detoxification versus AAT after
inpatient detoxification in terms of improving treatment outcomes. (3) The
expectations, acceptability and feasibility of the AAT training will be
investigated. If proven effective and feasible, this AAT training could be
easily implemented as a low-cost adjunctive treatment to improve treatment
outcomes for alcohol-dependent patients.
Study design
A multicentre randomized controlled trial, with a repeated-measures design
Intervention
After giving written informed consent, participants will be randomised and
allocated to one of the four Alcohol Avoidance Training (AAT) during or after
their inpatient alcohol detoxification (TAU):
1. a group of TAU + AAT during alcohol inpatient detoxification treatment
2. a group of TAU + placebo AAT during alcohol inpatient detoxification
treatment
3. a group of TAU + AAT after alcohol inpatient detoxification treatment
4. a group of TAU + placebo AAT after alcohol inpatient detoxification treatment
Participants will receive five AAT sessions during the first three weeks of
their inpatient treatment, or after week 3 to week 5 if they were allocated in
the after inpatient detoxification condition. During the AAT training,
participants are instructed to respond to certain types of images: with an
approach movement (pulling a joystick) or with an avoidance movement (pushing a
joystick). By pulling a joystick the size of the picture increases, while
pushing the lever decreases the size of the picture (Wiers et al., 2009).
Study burden and risks
There are no risks associated with participating in the study. Participants are
asked to complete the five AAT sessions during the first three weeks of the
inpatient alcohol detoxification treatment or after. AAT takes a maximum of 20
minutes per session. In addition, they are asked to report their level of
craving before and after each session (VAS, one question). Before the first AAT
and at the follow-up measurements, they are asked to complete five
questionnaires. Consisting of questions about substance use (4 questions),
craving (5 questions), psychological complaints (21 questions), AAT
expectations (4 questions) and AAT evaluation (acceptability and feasability)
(15 questions).
Hogedwarsstraat 3
Vught 5261LX
NL
Hogedwarsstraat 3
Vught 5261LX
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Informed consent
- 18 years or older
- meet the Diagnostic and Statistical Manual-5 criteria for alcohol use
disorder (AUD, American Psychiatric Association, 2013)
- medical indication for inpatient alcohol detoxification treatment
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study, if there is any medical or psychiatric
disorder or deficit in Dutch language proficiency that prohibits a good
understanding of questions and instructions or the ability to take part in the
AAT. Patients with a severe neurological disorder such as Korsakoff syndrome
will be excluded.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL71038.091.20 |