Trial document





This trial has been registered retrospectively.
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  DRKS00007797

Trial Description

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Title

Preventing relapse in alcoholics by training automatic avoidance and attention

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Trial Acronym

AvAtT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In a series of studies, we have shown that the relapse rate of alcoholics can be reduced by approx. 10% by means of a joystick-based training of automatic alcohol-avoidance tendencies. Other studies suggest that relapse rates may also be reduced by computer-based procedures that train automatic attention away from alcohol-related stimuli. Therefore, the current study is designed to find out whether an attention training of 6 sessions is as effective as the previously used 6-session alcohol-avoidance training, and whether a combination of both trainings (3+3 sessions) may be even more effective. Participants of the trainings will be alcohol-dependent patients of the salus clinic Lindow, and relapse rates will be determined at 1-year follow-up.

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Brief Summary in Scientific Language

In a series of studies, we have shown that the relapse rate of alcoholics can be reduced by approx. 10% by means of a joystick-based training of automatic alcohol-avoidance tendencies (Wiers et al., 2011; Eberl et al., 2013; 2014). Other studies suggest that relapse rates may also be reduced by computer-based procedures that train automatic attention away from alcohol-related stimuli (Schoenmakers et al., 2010). Therefore, the current study is designed as a randomized controlled trial to find out whether an attention training of 6 sessions is as effective as the previously used 6-session alcohol-avoidance training, and whether a combination of both trainings (3+3 sessions) may be even more effective. The control groups consist of patients who receive either placebo versions of the trainings, or no trainings at all. Participants of the study will be alcohol-dependent patients of the salus clinic Lindow, and relapse rates will be determined at 1-year follow-up.

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Organizational Data

  •   DRKS00007797
  •   2015/03/13
  •   [---]*
  •   yes
  •   Approved
  •   IP_Mü_Lindenmeyer_Phase_IV_Neuropsych_02022011, Ethikkommission der Fakultät für Human- und Sozialwissenschaften der TU Chemnitz, TU Chemnitz,
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F10 -  Mental and behavioural disorders due to use of alcohol
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Interventions/Observational Groups

  •   Active alcohol-avoidance training with 6 sessions of 200 trials each, in addition to treatment-as-usual. By means of a joystick, pictures of alcoholic beverages are always pushed away (avoidance), whereas pictures of non-alcoholic beverages are always pulled closer (approach).
  •   Active alcohol-attention training with 6 sessions of 200 trials each, in addition to treatment-as-usual. On each trial, two pictures are presented briefly. One shows an alcoholic beverages, the other one a non-alcoholic one. By means of a dot-probe task, attention is trained away from the alcohol pictures and towards the non-alcohol pictures.
  •   Active combination of Arm 1 and Arm 2 with constant toal number of sessions, in addition to treatment-as-usual: 3 sessions of alcohol-avoidance training, 3 sessions of alcohol-attention training. The order of the two trainings is counterbalanced.
  •   Placebo versions of Arm 1, Arm 2, and Arm 3, in addition to treatment-as-usual: In 6 sessions, patients do the same computer tasks, but without training. Alcohol pictures and non-alcohol pictures are both pulled and pushed with equal frequency, and attention is trained towards both alcohol pictures and non-alcohol pictures.
  •   Untrained control group that receives only treatment-as-usual.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, caregiver, assessor
  •   Placebo, Active control, No treatment
  •   Treatment
  •   Factorial
  •   N/A
  •   N/A
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Primary Outcome

Relapse at 1-year-follow-up

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Secondary Outcome

manipulation check: trainability. Measured by reaction times of responses to alcohol pictures and non-alcohol pictures during the pretest before training (2nd to 4th week of stay in clinic) and during the posttest after training (10th to 12th week of stay in clinic).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2010/09/01
  •   1500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   20   Years
  •   75   Years
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Additional Inclusion Criteria

Diagnosis F10 according to ICD-10

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Exclusion Criteria

none

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Radboud University Nijmegen
    • Mr.  Prof. Dr.  Mike  Rinck 
    • Montessorilaan 3
    • 6500 HE  Nijmegen
    • Netherlands
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    • salus klinik Lindow
    • Mr.  Dr.  Johannes  Lindenmeyer 
    • Straße nach Gühlen 10
    • 16835  Lindow
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Radboud University Nijmegen
    • Mr.  Prof. Dr.  Mike  Rinck 
    • Montessorilaan 3
    • 6500 HE  Nijmegen
    • Netherlands
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    • salus klinik Lindow
    • Mr.  Dr.  Johannes  Lindenmeyer 
    • Straße nach Gühlen 10
    • 16835  Lindow
    • Germany
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Sources of Monetary or Material Support

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    • Radboud University Nijmegen
    • Mr.  Prof. Dr.  Mike  Rinck 
    • Montessorilaan 3
    • 6500 HE  Nijmegen
    • Netherlands
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.