Trial document




drksid header

  DRKS00012642

Trial Description

start of 1:1-Block title

Title

Randomized-controlled study on cognitive bias modification in adolescents with a focus on cannabis addiction

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

UNdope

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Cannabis abuse or rather addiction are one of the most frequent causes for detoxification in child and adolescent psychiatry. High relapse rates and chronic courses with severe limitations of social functions are common. Therefore, treatments which reduce the risk of relapse after detoxification are urgently necessary. Initial studies from alcohol research show that computer-assisted methods with the principle of cognitive bias modification (CBM) could be helpful. According to the CBM principle, the approach behavior with regard to an addictive substance is specifically reduced. The aim of the present study is to investigate the effects of a cannabis-approach-avoidance training (CAAT) on the approach tendency in cannabis-addicted adolescents compared to placebo training. A computer and app (tablet) assisted CAAT will be inserted in adolescent inpatients, who are in cannabis detoxification in the child and adolescent psychiatry, Hamm, Germany. We expect that the approach tendency in response to cannabis-associated stimuli will be reduced with the result that less cannabis craving or rather fewer relapses are observed after six trainings sessions and at follow-up three month later.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Cannabis abuse or rather addiction are one of the most frequent causes for detoxification in child and adolescent psychiatry. High relapse rates and chronical courses with severe social functional limitations are frequent. Therefore, interventions which reduce the risk of relapse after detoxification are urgently necessary. Initial studies from alcohol research show that computer-assisted methods, such as the "alcohol- aproach -avoidance- training", with the principle of cognitive bias modification (CBM), could be helpful. The purpose of those trainings are to specifically reduce the approach behavior regarding an addictive substance. Recently, in alcohol research, the use of CBM-oriented training procedures has shown a reduction in approach behavior regarding alcohol-associated stimuli, with the result that fewer relapses were observed at follow-up one year later. Based on the promising findings from alcohol research, the aim of our study project is to investigate the effects of a cannabis- approach-avoidance training (CAAT) on the approach behavior of adolescents with cannabis addiction. So far, such interventions have not yet been inserted in cannabis-addicted adolescents in Germany. With a randomized controlled study design it is intended to evaluate the efficacy of a computer and app assisted CAAT for modifying attention control on cannabis-associated stimuli compared to a placebo training. We hypothesize that after 6 trainings sessions and at follow-up three month later the approach towards cannabis-related stimuli will be significantly reduced in partcipants who receive the intervention training. We believe that due to the changes in the approach tendency in reponse to cannabis, fewer cannabis craving or rather less relapses will be observed.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00012642
  •   2017/07/11
  •   [---]*
  •   yes
  •   Approved
  •   15-5878, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F12.2 -  Mental and behavioural disorders due to use of cannabinoids; Dependence syndrome
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Intervention training - Experimental group (EG):
    Participants randomly allocated to the experimental group will receive six CAAT sessions. In each session, 200 pictures with cannabis-associated and 200 pictures with neutral content are randomly displayed on the tablet (App) or computer screen. The pictures will be presented one by one and will be appear in a quasi-randomized order. In the EG condition the subjects push 100% of the cannabis pictures away (avoidance movement) and pull 100% of the neutral pictures to themselves (approach movement) (a wiping motion with the finger on the tablet or a joystick movement in the computer variant). In this way, the avoidance movement with regard to cannabis stimuli is trained specifically. Pushing a picture away went along with a decrease in picture size, whereas pulling a picture closer resulted in an increased size (zoom-effect). Participants receive an implicit instruction - i.e. they must decide by the color of the picture frame whether they push or pull a picture. One picture category is always presented with a blue picture frame and the other picture category with a purple picture frame. In each trainings session participants receive the instruction to push pictures with one frame colour and to pull the pictures with the other frame colour. Every trainings session lasts at least 10 minutes, as this has been shown as an optimal training duration in previous studies.
  •  
    Placebo training - Control group (CG):
    Participants randomly allocated to the control group (CG) will also receive six trainings sessions. As well as in the EG, in each session, 200 pictures with cannabis-associated and 200 pictures with neutral content are displayed randomly on the tablet or computer screen. The pictures will be presented one by one and will be appear in a quasi-randomized order. Likewise as in the EG, participants receive an implicit instruction or rather have to orient themselves on the frame colour (blue or rather purple) of the pictures when pulling or pushing a stimuli. However, unlike the EG training, in the placebo training 50% of the cannabis-related images and 50% of the neutral images are pushed (avoidance), respectively 50% of the stimuli of both categories are pulled (approach). Both, the avoidance and the approach movement to cannabis-related stimuli are trained equally. Also equal to the EC are the variation in picture size during avoidance (push=decrease picture size) and approach (pull= increase picture size) movements as well as the duration of the each trainings session.

end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

The primary outcome is the change in the approach tendency towards cannabis-assiciated stimuli. For this, a "cognitive bias score" is calculated which subtracts the response time for approaching a cannabis-associated stimulus from the response time for avoiding a cannabis-associated stimulus. A positive value suggests a approach tendency regarding cannabis-associated stimuli, a negative value suggests avoidance tendency.

The approach behavior towards cannabis-associated stimuli will be measured with an approach-avoidance task which is based on the AAT of Rinck and Becker (2007). In this task, which is performed on the computer or tablet app, the participants receive an implicit instruction - i.e. they must decide by the color of the picture frame whether they push or pull a picture. Pushing a picture away goes along with a decrease in picture size, whereas pulling a picture closer result in an increased size (zoom-effect). The present study will use two categories of pictures - 200 pictures with cannabis-associated and 200 pictures with neutral content are randomly displayed on the tablet or computer screen. One picture category is always presented with a blue picture frame and the other picture category with a purple picture frame. 50% of cannabis-related images and 50% of neutral images are pushed (avoidance movement), respectively 50% of the stimuli of both categories are pulled (approach movement) (like in the CG training). The pictures will be presented one by one and will appear in a quasi-randomized order. Participants start with 20 practice trials, followed by the 400 test trials. The AAT will be administered before training (pre), after six trainings sessions (post) as well as at follow up 3 months later to measure the approach and avoidance behavior. This AAT version is also used as control/ placebo training.

Another primary outcome is change in cannabis craving and cannabis consume (relapses).
The cannabis use and cannabis craving will be measured before the first trainings session, after the completion of the 6 training sessions and 3 months after the training (follow-up). The cannabis use disorder identification test (CUDIT, Adamson & Sellman, 2003) will be used for the measurement of cannabis use. The CUDIT is a screening questionnaire to assess the extent of harmful use of cannabis. Cannabis craving, on the one hand, will be measured with a visual analog scale with the endpoints 0 (currently no craving for cannabis) to 100 (currently a very strong craving for cannabis) and, on the other hand, with the Marijuana Craving Questionaire (MCQ, Heishman et al.2001).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

The secondary outcome criteria are the changes in the clinical and addiction-related symptomatology . Before the fist trainings session, after 6 trainings sessions and three months after trainings completion the following clinical parameters will be measured with the following questionnaires:

Alcohol use: AUDIT- Alkohol Use Disorder Indentifikation Test (Saunders et al., 1993);
Nicotine use: FTND – Fagerstroem Test for Nicotin Dependence (Bleich, Havemann-Reinecke, & Kornhuber, 2002);
Cannabis consume: CUDIT – Cannabis Use Disorder Identifikation Test (Adamson & Sellman, 2003);
Marihuana Craving: MCQ- Marijuana Craving Questionnaire (Heishman et al., 2001);
Online behavior: OSVK-S – Scale of online addiction behavior in children and adolescents (Wölfling, Müller, & Beutel, 2010);
Sensation Seeking: NISS – Need Inventory of Sensation Seeking (Roth, Hammelstein, & Brähler, 2014);
Temperament and Charakter: JTCI- Junior Temperament and Charakter Inventory (Goth & Schmeck, 2009);
Abstinence confidence: HEISA-16 - Heidelberg scales for abstinence confidence (Körkel, & Schindler, 2004);
State of Change: VSS – Stages of change scale (Heidenreich, Hoyer, & Fecht, 2001);
Depression: BDI- Becks Depression Inventory (Beck et al., 2006);
Sleeping behavior: PSQI- Pittsburgh Sleepquality Index (Buysse , Reynolds, Monk, Berman, Kupfer, 1988);
Trauma: CROPS- Child Report of Post-Traumatic Symptoms (Greenwald & Rule, 1999);
Anxiety: STAI- State Trait Angst Inventar (Laux, Glanzmann, Schaffner, & Spielberger, 1981).

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2018/01/31
  •   144
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

primary diagnosis of cannabis addiction, inpatient treatment

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Other primary substance use disorder, acute psychotic episode, low German language skills

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • LWL Universitätsklinik Hamm für Kinder- und Jugendpsychiatrie, Psychotherapie und Psychosomatik
    • Ms.  Prof. Dr.  Tanja  Legenbauer 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • LWL-Universitätsklinik Hamm der Ruhr-Universität Bochum
    • Ms.  Prof., Dr.  Tanja  Legenbauer 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • LWL-Universitätsklinik Hamm der Ruhr-Universität Bochum
    • Ms.  Prof. Dr.  Tanja  Legenbauer 
    • Heithofer Allee 64
    • 59071  Hamm
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • LWL Forschungsinstitut
    • 44181  Bochum
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
  • start of 1:1-Block address otherSupport
    • LWL Universitätsklinik Hamm für Kinder und Jugendpsychiatrie, Psychotherapie und Psychosomatik
    • Ms.  Prof. Dr. Tanja Legenbauer 
    • Heithofer Allee 64
    • 5071  Hamm
    • Germany
    end of 1:1-Block address otherSupport
    start of 1:1-Block address contact otherSupport
    •   023818935053
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact otherSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2020/05/28
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.