- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03460288
Computer-based Training (Retraining) for People With Gambling Problems (Retraining)
April 28, 2019 updated by: Universitätsklinikum Hamburg-Eppendorf
The study examines the efficacy and acceptance of a computer-based training program for individuals with problematic or pathological gambling behavior.
The study intends to investigate the extent to which the computer-based training program leads to a significant reduction in pathological gambling (primary outcome) when compared to a control group.
The study design is a randomized-controlled trial with one intervention group and one wait-list control group.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study examines the efficacy of a computer-based training program for individuals with problematic and pathological gambling behavior.
The main objective of the study is to investigate the extent to which the online program leads to a significant reduction in pathological gambling.
The primary outcome is the Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsory Scale (PG-YBOCS total score) as a measure of the severity of pathological gambling symptoms.
Secondary outcomes are further measures of gambling-related symptoms, such as the South Oaks Gambling Screen (SOGS), as well as rates of depression, measured with the Patient Health Questionnaire - 9 items depression module (PHQ-9), and rates of impulsivity, measured with the impulsivity subscale of the Eysenck's Impulsivity Inventory (I-7).
The training is expected to lead to a significant reduction in problematic/pathological gambling behavior (PG-YBOCS) and all secondary outcomes when compared to a control group.
The study design is a randomized-controlled trial with one intervention group and one wait-list control group and two assessment times (pre and post).
The intervention group receives the download link for the training program directly following the baseline survey and can use the training over a period of 8 weeks, whereas the wait-list control group receives access to the training after completion of the post-survey.
Study Type
Interventional
Enrollment (Actual)
141
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- informed consent
- access to internet
- sufficient command of the German language
- willingness to participate in two short (25-30 minutes) online surveys
- willingness to use the online program over a period of 8 weeks (participants who do not use the program are also included in the analysis)
- willingness to leave an (anonymous) email-address
- subjective need for treatment
Exclusion Criteria:
- presence of a lifetime diagnosis of schizophrenia or bipolar disorder
- acute suicidal tendency (assessed with item 9 of the PHQ-9, ≥3)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Change in SOGS from pre- to post-intervention (i.e. 8 week interval)
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Eysenck Impulsiveness Questionnaire - Subscale Impulsivity (I-7)
Time Frame: Change in I-7 from pre- to post-intervention (i.e. 8 week interval)
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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).
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Change in I-7 from pre- to post-intervention (i.e. 8 week interval)
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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).
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Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steffen Moritz, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 18, 2018
Primary Completion (Actual)
December 11, 2018
Study Completion (Actual)
December 11, 2018
Study Registration Dates
First Submitted
February 5, 2018
First Submitted That Met QC Criteria
March 8, 2018
First Posted (Actual)
March 9, 2018
Study Record Updates
Last Update Posted (Actual)
April 30, 2019
Last Update Submitted That Met QC Criteria
April 28, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Retraining
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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