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临床试验/NCT04190810
NCT04190810Unknown不适用

Mechanisms Underlying the Approach and Avoidance Task (AAT) in Smoking Cessation

Universitätsklinikum Hamburg-Eppendorf1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
75
试验地点
1
主要终点
Fagerström Test of Nicotine Dependence (FTND)

研究概览

简要总结

The approach and avoidance task (AAT) has evolved as a promising treatment add-on in the realm of psychology. Certain psychiatric diseases, such as behavioural addictions, social anxiety disorder, and arachnophobia, are characterized by a dysfunctional tendency to either approach or avoid disease-specific objects. This tendency can be measured by means of the approach and avoidance task. More precisely, by a diagnostic AAT, in which participants are instructed to react upon the format or the frame colour of a picture. For instance, pictures have to be pushed away if they are presented in landscape format and pulled towards oneself if they are presented in portrait format (or vice versa). Hence, the format (or the frame colour) becomes the task-relevant dimension, whereas the content of the picture becomes irrelevant for task completion. However, what generally becomes obvious in the psychiatric diseases mentioned above is that the task-irrelevant dimension (picture content) exerts an influence on reaction times. For instance, smokers are generally faster to respond to smoking-related pictures, when presented in a format requiring them to pull towards themselves, and slower to respond, if smoking pictures are shown in the format requiring them to push away a joystick (Wiers et al., 2013). This behavioural tendency has been termed an approach bias for cigarettes or smoking.

In order to counteract these dysfunctional approach or avoidance tendencies, an AAT-training has been developed. In this training participants/patients learn to either avoid or approach disease-specific objects. Smokers, for instance, learn to avoid smoking-related pictures by pushing or swiping the image away. It has been shown that these trainings can lower cigarette consumption among current smokers (Machulska, Zlomuzica, Rinck, Assian, & Margraf, 2016). The aim of the current study is to test whether the avoidance gesture is as important as suggested by the AAT's name or whether inhibiting the urge to approach smoking-related content might be enough to bring about the effect. Furthermore, possible changes in general and domain-specific (i.e. smoking-related) inhibition capacity, that might mediate the effect, will be assessed. Another focus of study will be on functional as well as structural neuronal changes, emerging as a consequence of the AAT-training.

详细描述

The approach and avoidance task (AAT) has turned out as both a promising diagnostic tool as well as treatment add-on in psychological science. The AAT constitutes one form of cognitive bias modification (CBM), which has been shown to be particularly effective in the field of behavioural addictions (Eberl et al., 2013; Wiers, Eberl, Rinck, Becker, & Lindenmeyer, 2011). The general logic underlying the AAT is to carry out actions that are either compatible or incompatible with an individual's action tendencies. For instance, nicotine addicted individuals tend to approach tobacco-related stimuli faster than control pictures, when they are instructed to react upon the format of a picture and not to its' content. This tendency of comparatively faster approaching and slower avoiding tobacco-related content has been termed an approach bias nicotine/tobacco. The AAT as a therapeutic tool tries to counteract or at least to attenuate approach or avoidance biases by instructing patients to carry out approach or avoidance gestures that are in conflict with an individual's acquired action tendencies.

Whereas the general effectiveness of the AAT as a clinical intervention has been demonstrated several times, little is known about possible mechanisms that might subserve these effects. Therefore, the current study is dedicated to shed some light on one such potential mechanism, i.e. the role of the avoidance gesture within the alcohol-AAT.

As already suggested by the name of the AAT, the avoidance gesture seems to be a key ingredient in bringing about therapeutic effects. However, recent empirical evidence has brought about some interesting findings, giving rise to an alternative explanation.

A study by Kühn et al. (2017), contrary to common-held beliefs, indicated that inhibition capacity can be trained. Inhibition, in turn, consistently has been linked to psychopathology and all kinds of behavioural addictions (Smith, Mattick, Jamadar, & Iredale, 2014). The game by Kühn et al. (2017), used to train inhibition, resembled the AAT in several ways, e.g. certain stimuli appearing on a treadmill had to be collected by swiping towards oneself and others had to be ignored and the objects slowly disappeared. The latter element contrasts with the AAT, since the ignored objects don't have to be pushed away. However, it resembles the AAT in the sense that in both cases stimuli slowly fade out of the screen and eventually disappear. These parallel let to the assumption that a new form of the alcohol AAT training might be equally effective in lowering relapse rates among alcoholic patients. More precisely, within the newly conceptualized AAT training, patients are instructed to inhibit the urge to respond in response to alcohol-related content and to observe the stimuli fading out of the screen. In contrast to the classical AAT training, this zooming out of alcoholic stimuli is not conditional on the avoidance gesture, i.e. swiping/pushing away the stimulus.

It is hypothesized that compared to a control group, in which tobacco and control stimuli have to be swiped to the left and right, both the classical AAT-and the inhibition group will be more successful in stopping or reducing smoking. The intervention includes a training period of four weeks. No intergroup differences in terms of smoking cessation and tobacco-related approach bias are expected for the classical AAT group and the inhibition group after the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants do not know that there exists more than one condition.

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • being mentally healthy
  • just having stopped smoking or having the urge to do so
  • adequate language skills
  • being right-handed

排除标准

  • MRI contra indications, such as claustrophobia, tinnitus, and having any non-removable ferromagnetic artefacts within the body
  • somatic or neurological disease that precludes the proper execution of the study

研究组 & 干预措施

Inhibition group

Experimental

The inhibition group gets the instructions to respond to pictures that are not related to smoking by swiping/pulling them towards themselves, whereas pictures with tobacco-related content shall be ignored. Up on pulling the pictures successively enlarge, whereas they shrink when ignored and slowly fade out.

干预措施: Inhibition (Behavioral)

Classical AAT group

Experimental

The classical AAT group is provided with a tablet on which an explicit AAT training is installed. Thus, just as participants in the inhibition group, participants are instructed to react upon non-smoking related images by swiping/pulling towards themselves the picture. Pictures containing tobacco-related content shall be pushed away. Up on pulling pictures enlarge and up on pushing they shrink until they fade out.

干预措施: Classical AAT (Behavioral)

Control group

Sham Comparator

This type of active control group receives the instructions to swipe tobacco-related pictures to the left and non-tobacco related pictures to the right (or vice versa depending on the sequential counterbalancing procedure).

干预措施: Control (Behavioral)

结局指标

主要结局

Fagerström Test of Nicotine Dependence (FTND)

时间窗: 2 months

Fagerstrom test for nicotine addiction determines the degree of nicotine dependence based on smoking habits and frequency.

Cigarette Dependence Scale

时间窗: 2 months

Measures the extent of nicotine dependence.

GoNoGo Task

时间窗: 2 months

Numbers 1-9 appear on the screen in random sequence. Participants are asked to respond as fast as possible by pushing the space bar on all trials except those showing the number 3. On these trials participants are asked to suppress, i.e. inhibit a response.

Stop Signal Task (SST)

时间窗: 2 months

Participants have to respond to pictures with blue and yellow frames by pressing a left and right computer key, respectively (or vice versa depending on counterbalancing). These key presses shall be executed as quick as possible, when pictures are presented. However, on certain trials an acoustic stop signal follows the presentation of the picture. On these trials participants are asked to inhibit their response, and hence not to press any key.

Number of cigarettes consumed within the last month

时间窗: 2 months

On each point of measurement the number of cigarettes that has been smoked during the last month will be assessed by means of a memory protocol.

Diagnostic AAT

时间窗: 2 months

Two diagnostic AAT scores will be assessed on each point of measurement. One on a tablet and the other employing a joystick and a computer. The sequence is the same across testing sessions for the respective participant, but will be randomly counterbalanced between participants.

次要结局

  • Beck's Depression Inventory(2 months)
  • Smoking Behavior of Meaningful Others (Questionnaire)(2 months)
  • Cue Exposure Questionnaire(2 months)
  • Questionnaire of Smoking Urges(2 months)
  • Obsessive Compulsive Smoking Scale(2 months)
  • Alcohol Use Disorders Identification Test (AUDIT)(2 months)
  • Barratt Impulsiveness Scale(2 months)
  • Commitment to Quitting Smoking Scale(2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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