Gambling, PathologicalRetrainingNCT03460288
Computer-based Training (Retraining) for People With Gambling Problems
A study testing Retraining (AAT) in people with Gambling, Pathological, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gambling, Pathological
- What is being tested?
- Retraining (AAT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2018to 11 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- presence of a lifetime diagnosis of schizophrenia or bipolar disorder
- acute suicidal tendency (assessed with item 9 of the PHQ-9, ≥3)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Gambling, Pathological
- Being tested
- Retraining (AAT)
- Keywords
- Gambling, Problematic Gambling, Pathological Gambling
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retraining (AAT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Behavioral: Retraining (AAT) |
| Wait-list control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval)
Secondary outcomes (3)
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.
Measured: Change in SOGS from pre- to post-intervention (i.e. 8 week interval)
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).
Measured: Change in I-7 from pre- to post-intervention (i.e. 8 week interval)
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).
Measured: Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start18 Jan 2018
- Primary completion11 Dec 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gambling, PathologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steffen Moritz, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460288
- Sponsor's protocol ID
- Retraining
- Acronym
- Retraining
- Status last verified
- Apr 2019
- First submitted
- 5 Feb 2018
- Last updated
- 30 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Training (Retraining) for People With Gambling Problems
- ClinicalTrials.gov ID
- NCT03460288
- Acronym / sponsor ID
- Retraining / Retraining
- Conditions
- Gambling, Pathological
- Keywords
- Gambling, Problematic Gambling, Pathological Gambling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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®.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Retraining (AAT)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. |
| Wait-list control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- presence of a lifetime diagnosis of schizophrenia or bipolar disorder
- acute suicidal tendency (assessed with item 9 of the PHQ-9, ≥3)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
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.
3 secondary outcomes
South Oaks Gambling Screen (SOGS)
Time frame: 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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steffen Moritz, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retraining (AAT) in people with Gambling, Pathological, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.