Smoking Cessation Clinical Trial
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | September 1, 2020 |
Est. primary completion date | September 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - being mentally healthy - just having stopped smoking or having the urge to do so - adequate language skills - being right-handed Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Clinic Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Eberl 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 2 — View Citation
Kühn 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 adul — View Citation
Machulska 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. — View Citation
Smith 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. Review. — View Citation
Wiers CE, Kühn 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/s00213-013-309 — View Citation
Wiers 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fagerström Test of Nicotine Dependence (FTND) | Fagerstrom test for nicotine addiction determines the degree of nicotine dependence based on smoking habits and frequency. | 2 months | |
Primary | 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. | 2 months | |
Primary | 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. | 2 months | |
Primary | Cigarette Dependence Scale | Measures the extent of nicotine dependence. | 2 months | |
Primary | 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. | 2 months | |
Primary | 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. | 2 months | |
Secondary | 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 | 2 months | |
Secondary | Cue Exposure Questionnaire | Measures the extent to which certain cues (situations or places) induce the urge to smoke a cigarette. | 2 months | |
Secondary | Questionnaire of Smoking Urges | Measures the current urge to smoke a cigarette. | 2 months | |
Secondary | Commitment to Quitting Smoking Scale | Assesses the motivation to stop/reduce smoking. | 2 months | |
Secondary | Obsessive Compulsive Smoking Scale | Measures the extent to which thoughts and actions are occupied by smoking urges. | 2 months | |
Secondary | Barratt Impulsiveness Scale | A questionnaire designed to assess the personality/behavioral construct of impulsiveness. | 2 months | |
Secondary | Beck's Depression Inventory | Assesses the degree of depressive symptoms. | 2 months | |
Secondary | Alcohol Use Disorders Identification Test (AUDIT) | The AUDIT is a simple method of screening for excessive drinking and alcohol use disorders. | 2 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Completed |
NCT04617444 -
The ESTxENDS Trial- Substudy on Effects of Using Electronic Nicotine Delivery Systems (ENDS) on Olfactory Function
|
N/A | |
Completed |
NCT02796391 -
Facilitating Smoking Cessation With Reduced Nicotine Cigarettes
|
Phase 2 | |
Completed |
NCT03397511 -
Incorporating Financial Incentives to Increase Smoking Cessation Among Asian Americans Residing in New York City
|
N/A | |
Not yet recruiting |
NCT05188287 -
A Culturally Tailored Smartphone Application for African American Smokers
|
N/A | |
Recruiting |
NCT05264428 -
The Effect of Honey on Lessening the Withdrawal Symptoms
|
N/A | |
Recruiting |
NCT05846841 -
Personalized Tobacco Treatment in Primary Care (MOTIVATE)
|
N/A | |
Completed |
NCT04133064 -
Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study
|
N/A | |
Completed |
NCT03187730 -
Integrating Financial Management Counseling and Smoking Cessation Counseling to Reduce Health and Economic Disparities in Low-Income Immigrants
|
Phase 4 | |
Completed |
NCT03474783 -
To Explore the Factors Affecting the Effectiveness of Smoking Cessation
|
N/A | |
Completed |
NCT04635358 -
Feasibility Study of Smoking Cessation for the Staff of a Hospital Center
|
N/A | |
Terminated |
NCT03670264 -
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
|
N/A | |
Not yet recruiting |
NCT06307496 -
VIDeOS for Smoking Cessation
|
N/A | |
Completed |
NCT02905656 -
Strategies to Promote Cessation in Smokers Who Are Not Ready To Quit
|
N/A | |
Completed |
NCT03206619 -
A Health Recommeder System to Tailor Message Preferences in a Smoking Cessation Programme
|
||
Completed |
NCT02997657 -
Positive Psychotherapy for Smoking Cessation Enhanced With Text Messaging: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT02562521 -
A Smoking Cessation Intervention for Yale Dining Employees
|
Phase 4 | |
Completed |
NCT02239770 -
Pharmacokinetics of Nicotine Film in Smokers
|
N/A | |
Recruiting |
NCT02422914 -
Benefits of Tobacco Free Cigarette
|
N/A |