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Computer-based Training (Retraining) for People With Gambling Problems (Retraining)

Primary Purpose

Gambling, Pathological

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Retraining (AAT)
Sponsored by
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gambling, Pathological focused on measuring Gambling, Problematic Gambling, Pathological Gambling

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Medical Center Hamburg-Eppendorf

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Wait-list control group

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
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.

Secondary Outcome Measures

South Oaks Gambling Screen (SOGS)
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)
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)
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).

Full Information

First Posted
February 5, 2018
Last Updated
April 28, 2019
Sponsor
Universitätsklinikum Hamburg-Eppendorf
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1. Study Identification

Unique Protocol Identification Number
NCT03460288
Brief Title
Computer-based Training (Retraining) for People With Gambling Problems
Acronym
Retraining
Official Title
Computer-based Training (Retraining) for People With Gambling Problems
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
December 11, 2018 (Actual)
Study Completion Date
December 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling, Pathological
Keywords
Gambling, Problematic Gambling, Pathological Gambling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Retraining (AAT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
Description
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.
Time Frame
Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval)
Secondary Outcome Measure Information:
Title
South Oaks Gambling Screen (SOGS)
Description
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.
Time Frame
Change in SOGS from pre- to post-intervention (i.e. 8 week interval)
Title
Eysenck Impulsiveness Questionnaire - Subscale Impulsivity (I-7)
Description
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).
Time Frame
Change in I-7 from pre- to post-intervention (i.e. 8 week interval)
Title
Patient Health Questionnaire - 9 items depression module (PHQ-9)
Description
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).
Time Frame
Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steffen Moritz, Prof. Dr.
Organizational Affiliation
Universitätsklinikum Hamburg-Eppendorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany

12. IPD Sharing Statement

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