Gambling, Pathologic Clinical Trial
Official title:
Computer-based Self-Help Program for People With Gambling Problems
| Verified date | April 2019 |
| Source | Universitätsklinikum Hamburg-Eppendorf |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The study examines the effectiveness of a computer-based self-help-program for individuals with problematic or 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 (primary outcome), depression and gambling-specific dysfunctional thoughts. The program is expected to lead to a significant reduction regarding all measures when compared to a control group. The study is conducted as a randomized-controlled trial with one intervention group and one wait-list control group.
| Status | Completed |
| Enrollment | 155 |
| Est. completion date | December 9, 2018 |
| Est. primary completion date | December 9, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - informed consent - access to internet - adequate usage of 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 that do not use the program are also included in the analysis) - willingness to leave an (anonymous) email-address - existence of the wish to receive treatment Exclusion Criteria: - existence of a lifetime diagnosis of schizophrenia or bipolar disorder - existence of an acute suicidal tendency (assessed with item 9 of the PHQ-9, =3) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
| Lead Sponsor | Collaborator |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS) | 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. | 1 week | |
| Secondary | Patient Health Questionnaire - 9 depression module (PHQ-9) | The Patient Health Questionnaire - 9 depression module is a self-rating measure of depressive symptom severity. The psychometric properties of the PHQ-9 are very good, with high internal consistency (Cronbach's a = .86 - .89; Kroenke, Spitzer, & Williams, 2001). Its sum score ranges from 0 to 27, with scores from 0-4 indicating minimal depression, 5-9 mild depression, 10-14 moderate depression and 15-27 severe depression. | 1 week | |
| Secondary | Gambling Attitudes and Beliefs Survey (GABS) | The GABS is a self-report questionnaire which explores gambling-related dysfunctional beliefs. In this study, we use a 15-item version of the GABS. Responses can be given on a four-point Likert scale (from 'strongly agree' to 'strongly disagree'). | time of assessment | |
| Secondary | 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. | 6 months |