Smoking CessationNCT04190810
The Approach and Avoidance Task (AAT) in Smoking Cessation
A study testing Inhibition and Classical AAT in people with Smoking Cessation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Inhibition and Classical AAT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2019to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being mentally healthy
- just having stopped smoking or having the urge to do so
- adequate language skills
- being right-handed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Clinic Hamburg-Eppendorf
Hamburg, 20246
Dimitrij Kugler, M.Sc., 0049 40 7410 24113, d.kugler@uke.de
About this study
Official title: Mechanisms Underlying the Approach and Avoidance Task (AAT) in Smoking Cessation
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.
Read the detailed description
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.
Furthermore, it will be explored whether inhibition capacity changes as a result of the intervention, the assumption being that inhibition capacity increases for both experimental groups, whereas no changes are expected for the control group. An interesting question concerns the domain-specificity of potential effects. In other words, does inhibition capacity improve only for the to be trained domain (i.e. tobacco) or does the general inhibition capacity improve, irrespective of the to be trained domain? Predictions on this issue are not straightforward, but it is assumed that both the general and domain-specific inhibition capacity improve for the experimental groups, when compared to the control group. Slightly more pronounced effects are expected for the domain-specific task, since the training calls for comparable skills.
Hypotheses concerning experimental changes in brain structure are hard to make, as, to the best of our knowledge, no research has been done on this topic up until now. Therefore, whole-brain analyses will be run on all voxels of the brain in order to explore any experimental changes both on the within and between subject level.
The same goes for functional changes in a Stop Signal Task (SST) and a cue reactivity paradigm. It will be explored whether the classical AAT group and the inhibition group show less reward-related activity in response to addiction-related stimuli than participants in the control group. Furthermore, it will be explored whether brain regions commonly associated with inhibition capacity show more activity in response to smoking-related stimuli, since this has been learned throughout the training period.
All secondary outcome measures (e.g. smoking-related questionnaires, Beck's Depression Inventory, Barratt's Impulsivity Scale, AUDIT) assess whether the experimental manipulations lead to a reduction in psychopathological symptoms. Therefore, both experimental groups are expected to show post-interventional declines in nicotine-dependence measures and other measures associated with dependence, such as mental well-being and impulsivity. In contrast, no changes across time are expected for the control group.
In order to test prior mentioned hypotheses, a randomized controlled trial will be conducted. Each of the three groups (inhibition group, classical AAT group, and control group) will consist out of 25 mentally healthy participants, who just stopped smoking or just start an attempt to quit smoking.
In total the study consists out of three points of measurement. After the baseline testing, which assesses participants' approach bias for tobacco, their tobacco history, tobacco consumption within the last months, a multitude of smoking-related questionnaires (see secondary outcome measures), the two inhibition tasks, brain structure and brain function, participants are provided with a tablet on which the AAT app is installed. The participants are asked to train with the app for at least 15 minutes daily within a four-week period. Following this training, the second point of measurement will take place. The general procedure is identical to the first point of measurement. Another four weeks later, the third point of measurement marks the end of the study. Once again, the measures are the same except for the fact that no MRI scan is realized on this last occasion, since the study is primarily interested in post-interventional brain changes.
- Conditions
- Smoking Cessation
- Being tested
- Inhibition, Classical AAT, Control
- Keywords
- Approach and Avoidance Task (AAT), Inhibition, fMRI
- Medical subject headings
- Smoking Cessation, Inhibition, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InhibitionBehavioural
Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
Classical AATBehavioural
Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
ControlBehavioural
Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Inhibition |
| 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. Receives: Behavioral: Classical AAT |
| 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). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fagerström Test of Nicotine Dependence (FTND)
Fagerstrom test for nicotine addiction determines the degree of nicotine dependence based on smoking habits and frequency.
Measured: 2 months
Number of cigarettes consumed within the last month
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.
Measured: 2 months
Diagnostic AAT
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.
Measured: 2 months
Cigarette Dependence Scale
Measures the extent of nicotine dependence.
Measured: 2 months
GoNoGo Task
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.
Measured: 2 months
Stop Signal Task (SST)
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.
Measured: 2 months
Secondary outcomes (8)
Smoking Behavior of Meaningful Others (Questionnaire)
This questionnaire assesses both the smoking habits of meaningful others as well as their appraisal of the participants' smoking behavior
Measured: 2 months
Cue Exposure Questionnaire
Measures the extent to which certain cues (situations or places) induce the urge to smoke a cigarette.
Measured: 2 months
Questionnaire of Smoking Urges
Measures the current urge to smoke a cigarette.
Measured: 2 months
Commitment to Quitting Smoking Scale
Assesses the motivation to stop/reduce smoking.
Measured: 2 months
Obsessive Compulsive Smoking Scale
Measures the extent to which thoughts and actions are occupied by smoking urges.
Measured: 2 months
Barratt Impulsiveness Scale
A questionnaire designed to assess the personality/behavioral construct of impulsiveness.
Measured: 2 months
Beck's Depression Inventory
Assesses the degree of depressive symptoms.
Measured: 2 months
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT is a simple method of screening for excessive drinking and alcohol use disorders.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2019
- Study start1 Dec 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Smokers, who just quitted smoking or start with smoking cessation, are randomly assigned to one of three conditions and are tested on three consecutive points in time.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Kühn, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04190810
- Sponsor's protocol ID
- AAT002
- Status last verified
- Dec 2019
- First submitted
- 11 Aug 2019
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wiers CE, Kuhn S, Javadi AH, Korucuoglu O, Wiers RW, Walter H, Gallinat J, Bermpohl F. Automatic approach bias towards smoking cues is present in smokers but not in ex-smokers. Psychopharmacology (Berl). 2013 Sep;229(1):187-97. doi: 10.1007/s00213-013-3098-5. Epub 2013 Apr 19.
PubMed 23604335Machulska A, Zlomuzica A, Rinck M, Assion HJ, Margraf J. Approach bias modification in inpatient psychiatric smokers. J Psychiatr Res. 2016 May;76:44-51. doi: 10.1016/j.jpsychires.2015.11.015. Epub 2015 Dec 13.
PubMed 26874269Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.
PubMed 23218805Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
PubMed 21389338Kuhn S, Lorenz RC, Weichenberger M, Becker M, Haesner M, O'Sullivan J, Steinert A, Steinhagen-Thiessen E, Brandhorst S, Bremer T, Gallinat J. Taking control! Structural and behavioural plasticity in response to game-based inhibition training in older adults. Neuroimage. 2017 Aug 1;156:199-206. doi: 10.1016/j.neuroimage.2017.05.026. Epub 2017 May 17.
PubMed 28527788Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24.
PubMed 25195081
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying the Approach and Avoidance Task (AAT) in Smoking Cessation
- ClinicalTrials.gov ID
- NCT04190810
- Acronym / sponsor ID
- AAT002
- Conditions
- Smoking Cessation
- Keywords
- Approach and Avoidance Task (AAT), Inhibition, fMRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 9 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Furthermore, it will be explored whether inhibition capacity changes as a result of the intervention, the assumption being that inhibition capacity increases for both experimental groups, whereas no changes are expected for the control group. An interesting question concerns the domain-specificity of potential effects. In other words, does inhibition capacity improve only for the to be trained domain (i.e. tobacco) or does the general inhibition capacity improve, irrespective of the to be trained domain? Predictions on this issue are not straightforward, but it is assumed that both the general and domain-specific inhibition capacity improve for the experimental groups, when compared to the control group. Slightly more pronounced effects are expected for the domain-specific task, since the training calls for comparable skills.
Hypotheses concerning experimental changes in brain structure are hard to make, as, to the best of our knowledge, no research has been done on this topic up until now. Therefore, whole-brain analyses will be run on all voxels of the brain in order to explore any experimental changes both on the within and between subject level.
The same goes for functional changes in a Stop Signal Task (SST) and a cue reactivity paradigm. It will be explored whether the classical AAT group and the inhibition group show less reward-related activity in response to addiction-related stimuli than participants in the control group. Furthermore, it will be explored whether brain regions commonly associated with inhibition capacity show more activity in response to smoking-related stimuli, since this has been learned throughout the training period.
All secondary outcome measures (e.g. smoking-related questionnaires, Beck's Depression Inventory, Barratt's Impulsivity Scale, AUDIT) assess whether the experimental manipulations lead to a reduction in psychopathological symptoms. Therefore, both experimental groups are expected to show post-interventional declines in nicotine-dependence measures and other measures associated with dependence, such as mental well-being and impulsivity. In contrast, no changes across time are expected for the control group.
In order to test prior mentioned hypotheses, a randomized controlled trial will be conducted. Each of the three groups (inhibition group, classical AAT group, and control group) will consist out of 25 mentally healthy participants, who just stopped smoking or just start an attempt to quit smoking.
In total the study consists out of three points of measurement. After the baseline testing, which assesses participants' approach bias for tobacco, their tobacco history, tobacco consumption within the last months, a multitude of smoking-related questionnaires (see secondary outcome measures), the two inhibition tasks, brain structure and brain function, participants are provided with a tablet on which the AAT app is installed. The participants are asked to train with the app for at least 15 minutes daily within a four-week period. Following this training, the second point of measurement will take place. The general procedure is identical to the first point of measurement. Another four weeks later, the third point of measurement marks the end of the study. Once again, the measures are the same except for the fact that no MRI scan is realized on this last occasion, since the study is primarily interested in post-interventional brain changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Smokers, who just quitted smoking or start with smoking cessation, are randomly assigned to one of three conditions and are tested on three consecutive points in time.
| Arm | Type | Receives |
|---|---|---|
| Inhibition group | Experimental | Behavioral: InhibitionThe 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. |
| Classical AAT group | Experimental | Behavioral: Classical AATThe 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. |
| Control group | Sham comparator | Behavioral: ControlThis 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). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- being mentally healthy
- just having stopped smoking or having the urge to do so
- adequate language skills
- being right-handed
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InhibitionParticipants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day. | Behavioural | Inhibition group |
| Classical AATParticipants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day. | Behavioural | Classical AAT group |
| ControlParticipants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day. | Behavioural | Control group |
Primary outcome
Fagerström Test of Nicotine Dependence (FTND)
Time frame: 2 months
Fagerstrom test for nicotine addiction determines the degree of nicotine dependence based on smoking habits and frequency.
Number of cigarettes consumed within the last month
Time frame: 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
Time frame: 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.
Cigarette Dependence Scale
Time frame: 2 months
Measures the extent of nicotine dependence.
GoNoGo Task
Time frame: 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)
Time frame: 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.
8 secondary outcomes
Smoking Behavior of Meaningful Others (Questionnaire)
Time frame: 2 months
Cue Exposure Questionnaire
Time frame: 2 months
Questionnaire of Smoking Urges
Time frame: 2 months
Commitment to Quitting Smoking Scale
Time frame: 2 months
Obsessive Compulsive Smoking Scale
Time frame: 2 months
Barratt Impulsiveness Scale
Time frame: 2 months
Beck's Depression Inventory
Time frame: 2 months
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Results publication: PubMed 23604335Wiers CE, Kuhn S, Javadi AH, Korucuoglu O, Wiers RW, Walter H, Gallinat J, Bermpohl F. Automatic approach bias towards smoking cues is present in smokers but not in ex-smokers. Psychopharmacology (Berl). 2013 Sep;229(1):187-97. doi: 10.1007/s00213-013-3098-5. Epub 2013 Apr 19.
- Results publication: PubMed 26874269Machulska A, Zlomuzica A, Rinck M, Assion HJ, Margraf J. Approach bias modification in inpatient psychiatric smokers. J Psychiatr Res. 2016 May;76:44-51. doi: 10.1016/j.jpsychires.2015.11.015. Epub 2015 Dec 13.
- Results publication: PubMed 23218805Eberl C, Wiers RW, Pawelczack S, Rinck M, Becker ES, Lindenmeyer J. Approach bias modification in alcohol dependence: do clinical effects replicate and for whom does it work best? Dev Cogn Neurosci. 2013 Apr;4:38-51. doi: 10.1016/j.dcn.2012.11.002. Epub 2012 Nov 14.
- Results publication: PubMed 21389338Wiers RW, Eberl C, Rinck M, Becker ES, Lindenmeyer J. Retraining automatic action tendencies changes alcoholic patients' approach bias for alcohol and improves treatment outcome. Psychol Sci. 2011 Apr;22(4):490-7. doi: 10.1177/0956797611400615. Epub 2011 Mar 9.
- Results publication: PubMed 28527788Kuhn S, Lorenz RC, Weichenberger M, Becker M, Haesner M, O'Sullivan J, Steinert A, Steinhagen-Thiessen E, Brandhorst S, Bremer T, Gallinat J. Taking control! Structural and behavioural plasticity in response to game-based inhibition training in older adults. Neuroimage. 2017 Aug 1;156:199-206. doi: 10.1016/j.neuroimage.2017.05.026. Epub 2017 May 17.
- Results publication: PubMed 25195081Smith JL, Mattick RP, Jamadar SD, Iredale JM. Deficits in behavioural inhibition in substance abuse and addiction: a meta-analysis. Drug Alcohol Depend. 2014 Dec 1;145:1-33. doi: 10.1016/j.drugalcdep.2014.08.009. Epub 2014 Aug 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simone Kühn, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhibition and Classical AAT in people with Smoking Cessation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dimitrij Kugler, M.Sc. (0049 40 7410 24113, d.kugler@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fagerström Test of Nicotine Dependence (FTND) (time frame: 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04190810, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.