The Approach and Avoidance Task (AAT) in Alcoholic Inpatients

NCT04054336 | Unknown

• 1 other identifier: AAT001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. In this so-called diagnostic AAT 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 the task-irrelevant dimension. 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, alcoholic patients are generally faster to respond if alcoholic pictures are presented in a format requiring them to pull towards themselves and slower to respond if alcoholic pictures are shown in the format requiring them to push away a joystick. This behavioural tendency has been termed an approach bias for alcohol. 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. Alcohol-dependent patients, for instance, learn to avoid alcohol-related pictures by pushing or swiping the image away. It has been shown that these trainings can enhance treatment outcome (e.g. lower relapse rates) among alcohol-addicted patients (Wiers, Eberl, Rinck, Becker, \& Lindenmeyer, 2011). 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 alcoholic content might be enough to bring about the effect.

Conditions

Alcohol Dependence

Keywords

Approach and Avoidance Task, Inhibition

Outcome Measures

Primary Outcomes (2)

• Alcohol consumption

  Is measured by means of the timeline followback (TLFB). In the TLFB a thirty day period prior to hospitalization is inquired to get an impression of the alcohol consumption before detoxification. Both after the intervention period and at the follow-up measure 9 weeks after the end of the intervention period the TLFB is administered to the participants again. Thus, in total a period of 3 months after the enrollment in the study is captured by means of the TLFB and can be compared between groups and with baseline consumption of each individual.

  3 months

• Relapse rate

  At each point of measurement it is inquired whether participants had a relapse. In order to enrich these self-reports, breathalysers are used to screen for possible alcohol intake prior to the appointment.

  3 months

Secondary Outcomes (12)

• Diagnostic AAT

  3 months

• Obsessive Compulsive Drinking Scale

  3 months

• Alcohol Urge Questionnaire

  3 months

• The State Trait Anxiety Inventory (STAI)

  3 months

• Positive and Negative Affect Schedule

  3 months

Study Arms (3)

Inhibition group

EXPERIMENTAL

The inhibition group gets the instructions to respond to pictures containing soft drinks by swiping/pulling them towards themselves, whereas pictures with alcoholic content shall be ignored. Up on pulling the pictures successively enlarge, whereas they shrink when ignored and slowly fade out.

Behavioral: Inhibit AAT

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 soft drinks by swiping/pulling towards themselves the picture. Pictures containing alcoholic 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 alcohol pictures to the left and soft drink pictures to the right (or vice versa depending on the sequential counterbalancing procedure).

Behavioral: Control Group

Interventions

Inhibit AAT BEHAVIORAL

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 AAT BEHAVIORAL

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

Control Group BEHAVIORAL

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

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of alcohol dependence (SKID-I)
• Abstinence from alcohol (at least 72 hours) and absence of major withdrawal symptoms
• Being in between 18-76 years of age
• Being able to understand rationales of the study and signing written informed consent
• Currently being inpatient seeking help overcoming alcohol dependence
• Medication allowed: Antiepileptic's (such as Carbamezepin), antidepressants, substances to treat other non-psychiatric diseases

You may not qualify if:

• Impaired ability to cooperate
• Presence of another substance dependency than alcohol and nicotine within the last year
• Presence of another axis-I disorder that interferes with the ability to cooperate within the study programme
• Current episode of a major depression
• Presence of axis-II disorders
• Presence of schizoaffective disorders
• Alcohol consumption in between withdrawal and start of the study
• Somatic or neurological disease that precludes the proper execution of the study
• Long-term intake of neuroleptics or hypnotics
• Current intake of benzodiazepines or Clomethiazol (in the period of five half-value times prior to the start of the study)
• Participation in other studies or other treatments than treatment as usual
• Planned long-term therapy after 3-week withdrawal programme
• Being homeless
• Prior electroconvulsive therapy
• Language barriers that preclude proper understanding of study contents

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Clinic Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 28527788 RESULT

• 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.

  PMID: 23218805 RESULT

• 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.

  PMID: 21389338 RESULT

• 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.

  PMID: 25195081 RESULT

MeSH Terms

Conditions

Alcoholism; Inhibition, Psychological

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Simone Kühn, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dimitrij Kugler, M.Sc.

CONTACT

0049 40 7410 24113; d.kugler@uke.de

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
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Alcohol patients are randomly assigned to one of three conditions and are tested on three consecutive points in time.

Study Record Dates

• First Submitted: August 11, 2019
• First Posted: August 13, 2019
• Study Start: February 2, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)