Trial document





This trial has been registered retrospectively.
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  DRKS00009751

Trial Description

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Title

Association Splitting - A first trial of a new method to reduce craving

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Association Splitting (AS) is a new cognitive intervention, which aims to reduce cravings among patients with alcohol use disorders (AUDs). AS is thought to create new associations with alcohol-related stimuli (e.g., wine) by strengthening neutral associations (e.g., wine-cheese, bar-barbell). The goal of the study was to compare AS to an active control condition (Exercise Therapy) in patients currently completing an inpatient treatment program for alcohol dependence. The change in craving severity was compared after 4 weeks, as well as 6 months later.

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Brief Summary in Scientific Language

Association Splitting (AS) is a novel cognitive intervention, which aims to disrupt automatic cognitive associations, with the ultimate goal among patients with alcohol use disorders (AUDs) of reducing craving. AS targets intrusive thoughts, characterized as unwanted, repetitive and stereotypical thoughts that are difficult to resist, by strengthening neutral associations for alcohol-related stimuli (e.g., bar – barbell [similar word], wine – cheese [occur together often], flask – mask [rhyme]). It is hypothesized that by creating new associations with alcohol-related stimuli, attention is diverted away from alcohol-related cognitions and toward neutral associations, thus leading to decreased cravings and risk for relapse. The goal of the study was to compare AS to an active control condition (Exercise Therapy) in patients currently completing an inpatient treatment program for alcohol dependence via a randomized, controlled, observer-blind trial with three time points: (T1) before intervention; (T2) immediately after intervention (4 weeks), (T3) 6-month follow-up. Change in severity of cravings, as assessed by the Obsessive Compulsive Drinking Scale (OCDS) was the primary outcome (hypothesis: greater decline from T1 to T3 in favor of AS). The secondary outcome was the Alcohol Craving Questionnaire (ACQ), which also measures cravings (hypothesis: greater improvement from T1 to T3 under experimental intervention relative to control).

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Organizational Data

  •   DRKS00009751
  •   2015/12/30
  •   [---]*
  •   yes
  •   Approved
  •   PV3346, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

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Health Condition or Problem studied

  •   Alcohol Dependence
  •   F10.2 -  Mental and behavioural disorders due to use of alcohol; Dependence syndrome
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Interventions/Observational Groups

  •   Association Splitting for Substance Abuse
    The treatment was administered in a group therapy setting over three weeks in which there were a total of three 90-minute sessions. Groups were comprised of two to four patients. Each patient was given a self-help manual that provides detailed information regarding the following topics: craving, how cognitive associations are formed with regard to craving and alcohol use, the theory supporting the AS techniques, application of and practice with AS, many examples of new associations, and examples of incorrect practicing of the technique. The AS group sessions were developed to follow the format of the self-help manual. In the first session, patients are provided with a general overview of the theoretical background for the treatment. After this, the AS technique is presented along with general examples (e.g., for beer, wine) and worksheets are given to explain how to use the technique. In Session 2, the AS model is applied to cravings and the patient’s own alcohol-related cognitions. The group is asked to share alcohol-related thoughts and concrete keywords are identified (i.e., vodka, wine, relaxation, soccer, etc.) that can cause or maintain cravings. The group is asked to find several neutral or positive associations to every identified keyword. Therapists collect the associations and design individual, illustrated worksheets for every participant (see Figure 1) immediately after the session. Patients are asked to practice AS on their own during the week. In the third and final session, patients are asked if they have problems or questions related to their AS practice. Further associations with the reported thoughts are gathered and discussed with the patients, and additional AS examples are given, if needed. Patients are asked to practice their individual AS exercises daily and to think of further associations. It is discussed how patients can find pictures or other stimuli to illustrate their associations and how to create worksheets on their own. Finally, patients are asked about if they feel ready to complete the AS exercises independently, as well as possible problems that could arise.
  •  
    Exercise Therapy (ET) was utilized as an active control group. ET is part of the standard program for inpatients on the Substance Abuse unit in which a variety of physical activities are offered.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The Obsessive Compulsive Drinking Scale (OCDS) measures cravings over the past seven days. It includes 14 items that are rated on a 5-point Likert scale by the patient. Two subscale scores can be calculated (obsessions and compulsions). The OCDS provides an indication of the severity of an AUD. The difference in OCDS total score from T1 to T3 serves as the primary outcome parameter. The OCDS was completed at three outcome time points: Baseline, post-assessment (4 weeks after baseline) and follow-up (6 months).

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Secondary Outcome

Changes on the Alcohol Craving Questionnaire (ACQ) serve as the secondary outcome. The ACQ queries about the cravings the patient is experiencing while completing the questionnaire. It includes 30 items that are rated on a 7-point Likert scale. The OCDS was completed at two time points: Baseline and post-assessment (4 weeks after baseline)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2009/10/23
  •   72
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1) Age between 18 and 75 years
2) Diagnosis of alcohol dependence as verified by the Mini International Neuropsychiatric Interview (MINI) as well as the Alcohol Use Disorders Test (AUDIT) and the Munich Alcoholism Test
3) Informed consent
4) Current participation in an inpatient Substance Abuse Treatment program at the University Medical Center Hamburg-Eppendorf
5) Sufficient German language ability

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Exclusion Criteria

Individuals who had a current or past diagnosis of psychosis were excluded.

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Addresses

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    • Universitätsklinikum Hamburg-EppendorfKlinik für Psychatrie und PsychotherapieArbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr. phil.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   040 7410-56565
    •   040 7410-57566
    •   moritz at uke.de
    •   [---]*
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    • Universitätsklinikum Hamburg-EppendorfKlinik für Psychatrie und PsychotherapieArbeitsgruppe Klinische Neuropsychologie
    • Mr.  Prof. Dr. phil.  Steffen  Moritz 
    • Martinistraße 52
    • 20246  Hamburg
    • Germany
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    •   040 7410-56565
    •   040 7410-57566
    •   moritz at uke.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Werner-Otto-Stiftung
    • Werner-Otto-Strasse 1-7
    • 22179  Hamburg
    • Germany
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    •   04064611082
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2010/12/30
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Trial Publications, Results and other Documents

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