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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
141

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
      • Hamburg, Germany, 20246
        • University Medical Center Hamburg-Eppendorf

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Change in SOGS from pre- to post-intervention (i.e. 8 week interval)
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).
Change in I-7 from pre- to post-intervention (i.e. 8 week interval)
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).
Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitätsklinikum Hamburg-Eppendorf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steffen Moritz, Prof. Dr., Universitatsklinikum 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Gambling, Pathological

Clinical Trials on Retraining (AAT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings