NCT04190810

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 9, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

December 9, 2019

Status Verified

December 1, 2019

Enrollment Period

9 months

First QC Date

August 11, 2019

Last Update Submit

December 6, 2019

Conditions

Keywords

Approach and Avoidance Task (AAT)InhibitionfMRI

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • Cigarette Dependence Scale

    Measures the extent of nicotine dependence.

    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.

    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.

    2 months

Secondary Outcomes (8)

  • Smoking Behavior of Meaningful Others (Questionnaire)

    2 months

  • Cue Exposure Questionnaire

    2 months

  • Questionnaire of Smoking Urges

    2 months

  • Commitment to Quitting Smoking Scale

    2 months

  • Obsessive Compulsive Smoking Scale

    2 months

  • +3 more secondary outcomes

Study Arms (3)

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.

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.

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).

Behavioral: Control

Interventions

InhibitionBEHAVIORAL

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.

Inhibition group
Classical AATBEHAVIORAL

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 AAT group
ControlBEHAVIORAL

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.

Control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (6)

  • 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.

  • 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.

  • 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 2012 Nov 14.

  • 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 Mar 9.

  • Kuhn 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.

  • 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.

MeSH Terms

Conditions

Smoking CessationInhibition, Psychological

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Simone Kühn, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrij Kugler, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants do not know that there exists more than one condition.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2019

First Posted

December 9, 2019

Study Start

December 1, 2019

Primary Completion

September 1, 2020

Study Completion

September 1, 2020

Last Updated

December 9, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations