Trial document




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  DRKS00019221

Trial Description

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Title

The efficacy of Cognitive Bias Modification as an add-on in smoking cessation: A randomized-controlled double-blind study

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Trial Acronym

CBM

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URL of the Trial

http://www.retrainyourbrain.de

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Brief Summary in Lay Language

Tobacco dependence is one of the most common mental disorders in Germany. Although most smokers are aware of the long-term negative health consequences and the majority wants to quit smoking, only a minority achieves long-term abstinence. One possible explanation for this apparent contradiction is provided by studies that have shown that automatic processes play an important role in maintaining tobacco dependence. In recent years, there has been an increasing effort to take these automatic processes into account. The planned randomized controlled, double-blind study will investigate whether the efficacy of an established smoking cessation intervention (smokefree® program) can be increased by combining it with a computer training aiming at changing the more automatic processes. Individuals aged 18 to 70 years who suffer from tobacco dependence can participate in the study (for further in- and exclusion criteria see below). All participants take part in the smoking cessation intervention, which consists of a block event on a single course day (approx. 7h) and a telephone appointment after approx. one week (maximum 15 minutes). Following the smoking cessation intervention, participants are randomized to one of three conditions on a course-by-course basis: One third of the courses receives a specific computer training in addition to the smoking cessation intervention, one third receives a general computer training in addition to the smoking cessation intervention, and another third does not receive any additional intervention. It is expected that participants who receive the smoking cessation intervention in combination with the specific computer training will have a higher abstinence rate after six months and that participants who relapse will have a significantly lower daily cigarette consumption compared to the other two groups.

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Brief Summary in Scientific Language

Tobacco dependence is one of the most common mental disorders in Germany (Jacobi et al., 2014). Although most smokers are aware of the long-term negative health consequences and the majority wants to quit smoking, long-term abstinence is the exception rather than the norm, even after receiving treatment (Mottillo et al., 2009). Evidence-based treatments either aim at a pharmacological substitution or at the modification of the more strategic types of information processing. Automatic processes are currently not taken into account sufficiently. The planned randomized controlled, double-blind study pursues two goals: (1) The study aims to investigate the efficacy of Cognitive Bias Modification as a specific add-on to a well-established smoking cessation intervention in a sample of regular smokers. (2) If Cognitive Bias Modification shows incremental efficacy, possible working mechanisms will be investigated. We hypothesize that the smoking cessation intervention + Cognitive Bias Modification will increase 6-month abstinence rates and will reduce daily cigarette consumption in participants who relapsed.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00019221
  •   2019/11/11
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  •   yes
  •   Approved
  •   23_c_2019, Ethik-Kommission der Medizinischen Fakultät der Ludwig-Maximilians-Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   F17.2 -  Mental and behavioural disorders due to use of tobacco; Dependence syndrome
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Interventions/Observational Groups

  •   Treatment-as-usual (TAU) + Cognitive Bias Modification (using the Approach-Avoidance Task [AAT])
    Treatment-as-usual (Smoke-free® program,): for further information see: https://www.rauchfrei-programm.de/schulungsangebote/beschreibung-fuer-fachleute.html.
    Add-On (Cognitive Bias Modification [CBM]): During the training, which is based on the Approach-Avoidance Task and adapted for tobacco dependence, participants will be presented smoking-related and positive images in a fully randomized order. Participants will be instructed to either pull the images closer or push the images away with a joystick, depending on the tilt (5% to the left or 5% to the right) of the images. In CBM, the instruction is chosen so that all smoking-related images are pushed away and all positive images are pulled. After having finished the smoking cessation intervention, the CBM training should be conducted daily for one week (240 trials per training session).
  •   Treatment-as-usual (TAU) + Sham training (using the Approach-Avoidance Task [AAT])
    During the training, which is based on the Approach-Avoidance Task and adapted for tobacco dependence, participants will be presented smoking-related and positive images in a fully randomized order. Participants will be instructed to either pull the images closer or push the images away with a joystick, depending on the tilt (5% to the left or 5% to the right) of the images. In the Sham condition, the instruction is chosen so that 50% of the smoking-related and positive images have to be pulled and 50% of the smoking-related and positive images have to be pushed. The only difference between the CBM and the Sham training is the contingency (240 trials per training session).
  •   Treatment-as-usual (TAU) only
    Participants who are randomized to the third arm receive the treatment-as-usual (i.e., smoking cessation intervention), but no add-on intervention
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor
  •   Placebo, Other
  •   Treatment
  •   Parallel
  •   III
  •   N/A
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Primary Outcome

Abstinence at the 6-month follow-up, defined by the following criteria (Russell Standard, see West et al., 2005)
(7) Sustained period of abstinence
(8) Sustained abstinence is defined as smoking not more than five cigarettes from start of the abstinence period and biochemical verification.
(9) Biochemische Überprüfung (CO-Test): CO ≤ 9ppm.
(10) Intention-to-treat Analyse
(11) Berücksichtigung von Teilnehmer/-innen bei der Analyse, die das Studienprotokoll verletzt haben (z.B. Einnahme von Nikotinersatzpräparaten)
(12) Die Follow-Up Erhebung sollte verblindet erfolgen (Teilnehmer/-innen und Untersucher/-innen).

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Secondary Outcome

1. Efficacy
Secondary analyses will be carried out to investigate whether the combination of treatment-as-usual + CBM can achieve a greater reduction in daily cigarette consumption, a greater reduction of tobacco dependence (CO measurement, Cigarette Dependence Scale, Brief Questionnaire of Smoking Urges) at the post-assessment and a greater reduction in daily cigarette consumption and tobacco dependence (Cigarette Dependence Scale) at the 6-month follow-up compared to the control groups.
Finally, it should be examined whether the interventions have an influence on the subjective impairments caused by physical and psychological symptoms (Brief Symptom Inventory).

2. Working mechanisms
Additionally, possible working mechanisms will be investigated. So far, it has not been systematically examined whether effects of CBM (based on the Approach-Avoidance Task) is due to (a) the postulated reduction of implicit approach tendencies to smoke-relevant stimuli (as assessed with the Approach-Avoidance Task) or (b) the change of other processes, for example the devaluation of the stimuli (as assessed with the Implicit Association Task [valence]). Furthermore, it will be investigated whether effects of CBM generalize to another paradigm aiming to assess approach tendencies (as assessed with the Implicit Association Task [approach-avoidance]) generalize and whether reacitvity (psychophysiology EMG, acoustic startle) for smoking-related stimuli changes.
Finally, it should be examined whether the automatic processes are affected by treatment-as-usual .

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/11/13
  •   336
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

i. Age 18-70 years
ii. CO ≥ 10 ppm
iii. Fagerstrøm Test for Nicotine Dependence ≥ 3
iv. Consumption of at least 10 cigarettes daily within the last 12 months
v. No consumption of nicotine replacement therapy (NRT) and no pharmacological smoking cessation therapry 3 months prior to study participation
vi. Willingness to abstain from NRT, e-cigarettes and any other smoking cessation intervention during study participation
vii. Interest to participate in the smokefree program

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Exclusion Criteria

i. Severe psychiatric disorder (e.g., bipolar disorder, psychosis)
ii. Severe neurological disorder (e.g., z.B. Morbus Parkinson, multiple sclerosis)
iii. Acute suicidality
iv. Moderate substance dependence (> criteria fulfilled according to DSM-5; except tobacco)
v. Pregnancy or nursing
vi. Insufficient knowledge of German language

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Addresses

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    • Ludwig-Maximilians-Universität München
    • Ms.  PD Dr.  Charlotte   Wittekind 
    • Leopoldstr. 13
    • 80802  München
    • Germany
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    • Tabakambulanz des Klinikums der Universität
    • Mr.  Dr.  Tobias  Rüther 
    • Nußbaumstr. 7
    • 80336  München
    • Germany
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    • Ludwig-Maximilians-Universität MünchenLehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  PD Dr.  Charlotte  Wittekind 
    • Leopoldstr. 13
    • 80802  München
    • Germany
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    • Ludwig-Maximilians-Universität MünchenLehrstuhl für Klinische Psychologie und Psychotherapie
    • Ms.  PD Dr.  Charlotte  Wittekind 
    • Leopoldstr. 13
    • 80802  München
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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