Clinical trial NCT03372226: Computer-based Self-Help Program for People With Gambling Problems
Official title: Computer-based Self-Help Program for People With Gambling Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling, Pathologic
Keywords: Gambling
Problematic Gambling
Pathological Gambling
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomly controlled study with 2 conditions: Condition 1: Online Intervention Program (treatment of emotional and gambling-related symptoms), condition 2: Wait-list control group (access to the online program after the post-assessment).

Two assessments-points, the intervention period (pre-post) is eight weeks. At both measuring points sociodemographic and pathological data are obtained with an internet survey on Unipark®.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study examines the effectiveness of a computer-based self-help-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 PG-Y-BOCS as a measure of the severity of pathological gambling symptoms. Secondary outcomes are rates of depression, measured with the PHQ-9 as well as gambling-specific cognitive biases, measured with the GABS. The program is expected to lead to a significant reduction in problematic/pathological gambling behavior (PG-Y-BOCS) and also to declines in both depressive symptoms (PHQ-9) and gambling-specific cognitive biases (GABS). The study is conducted as a randomized-controlled trial with one intervention group and one wait-list control group. The intervention group receives the login data directly following the baseline survey and can use the program over a period of 8 weeks, whereas the wait-list control group receives access to the program after completion of the post-survey.

Eligibility criteria: 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)

Primary outcomes:
measure: Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS)
timeFrame: 1 week
Secondary outcomes:
measure: Patient Health Questionnaire - 9 depression module (PHQ-9)
timeFrame: 1 week
measure: Gambling Attitudes and Beliefs Survey (GABS)
timeFrame: time of assessment
measure: South Oaks Gambling Screen (SOGS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Steffen Moritz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gehlenborg J, Moritz S, Bucker L. The Dimensional Structure of the Gambling Attitudes and Beliefs Survey: Challenging the Assumption of the Unidimensionality of Gambling-Specific Cognitive Distortions. J Gambl Stud. 2023 Mar;39(1):75-86. doi: 10.1007/s10899-022-10133-7. Epub 2022 May 28.
citation: Bucker L, Gehlenborg J, Moritz S, Westermann S. A randomized controlled trial on a self-guided Internet-based intervention for gambling problems. Sci Rep. 2021 Jun 22;11(1):13033. doi: 10.1038/s41598-021-92242-8.
citation: Bucker L, Westermann S, Kuhn S, Moritz S. A self-guided Internet-based intervention for individuals with gambling problems: study protocol for a randomized controlled trial. Trials. 2019 Jan 23;20(1):74. doi: 10.1186/s13063-019-3176-z.