Computer-based Training (Retraining) for People With Gambling Problems (Retraining)
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|ClinicalTrials.gov Identifier: NCT03460288|
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : April 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gambling, Pathological||Behavioral: Retraining (AAT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||141 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
The study is a randomly controlled study with 2 conditions: Condition 1: Computer-based training program (retraining), condition 2: Wait-list control group (access to the training after the post-assessment).
Two assessments-points, the intervention period (pre-post) is eight weeks. Sociodemographic and pathological data are obtained with an internet survey on Unipark®.
|Masking:||None (Open Label)|
|Official Title:||Computer-based Training (Retraining) for People With Gambling Problems|
|Actual Study Start Date :||January 18, 2018|
|Actual Primary Completion Date :||December 11, 2018|
|Actual Study Completion Date :||December 11, 2018|
Experimental: Intervention Group
The training-program includes ten pictures related to slot-machine gambling and 10 neutral pictures that need to be either pushed (i.e., avoidance) or pulled (i.e., approach) with the computer mouse or finger (when a tablet is used) according to a non-affective dimension (color of the frame). Pictures are presented in random order.
Behavioral: Retraining (AAT)
The training program is based upon the approach-avoidance task (AAT) and can be easily performed on a computer, laptop or tablet. There is a total of 20 pictures, 10 slot-machine gambling related pictures and 10 neutral pictures that were already used in a prior study (Wittekind et al., submitted). The pictures appear on the computer screen and have to be either pushed or pulled. Pushing and pulling depends on a masked instruction (not related to the content of the pictures, but to the color of the frame). All gambling-related pictures are framed with the color that is instructed to be pushed, all neutral pictures are framed with the color that is instructed to be pulled.
No Intervention: Wait-list control group
The participants of the wait-list control condition do not receive the retraining intervention during the intervention period of 8 weeks, but may continue any treatment that has already been started before, including pharmacological treatment. Participants in the wait-list control condition receive full access to the training program after completion of the post-assessment.
- Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) [ Time Frame: Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval) ]The total score consists of ten items that measure the severity of gambling symptoms within the past week. The first five questions assess urges and thoughts associated with gambling, whereas the last five questions assess the behavioral component of the disorder. The sum score of each subscale ranges from 0-20. Each subscale can be analyzed separately as well as together as a total score (primary outcome). The total score can be interpreted as follows: 0-7: sub-clinical, 8-15: mild, 16-23: moderate, 24-31: severe and 32-40: extreme gambling symptoms.
- South Oaks Gambling Screen (SOGS) [ Time Frame: Change in SOGS from pre- to post-intervention (i.e. 8 week interval) ]20-items self-report measure to screen for engagement in gambling activities and gambling-related problems. A score between 0-2 corresponds to non-problematic gambling, a score of 3-4 to at-risk gambling, and a score of 5-20 to probable pathological gambling.
- Eysenck Impulsiveness Questionnaire - Subscale Impulsivity (I-7) [ Time Frame: Change in I-7 from pre- to post-intervention (i.e. 8 week interval) ]Impulsivity will be assessed with the 17-item impulsivity subscale of the Eysenck Impulsiveness Questionnaire, which consists of the three subscales impulsiveness, venturesomeness, and empathy (Eysenck, Pearson, Easting, & Allsopp, 1985). The reliability of the subscale is good (α = .82 - .85).
- Patient Health Questionnaire - 9 items depression module (PHQ-9) [ Time Frame: Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval) ]The PHQ-9 is used to assess depressive symptoms over the past week. The nine items of the questionnaire are based upon the diagnostic criteria of major depression. Internal consistency of the scale is very good (Cronbach´s α = .86 - .89).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460288
|University Medical Center Hamburg-Eppendorf|
|Hamburg, Germany, 20246|
|Principal Investigator:||Steffen Moritz, Prof. Dr.||Universitätsklinikum Hamburg-Eppendorf|