Clinical trial NCT03460288: Computer-based Training (Retraining) for People With Gambling Problems
Official title: Computer-based Training (Retraining) for People With Gambling Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gambling, Pathological
Keywords: Gambling, Problematic Gambling, Pathological Gambling
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 141
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: 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®.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
timeFrame: Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval)
Secondary outcomes:
measure: South Oaks Gambling Screen (SOGS)
timeFrame: Change in SOGS from pre- to post-intervention (i.e. 8 week interval)
measure: Eysenck Impulsiveness Questionnaire - Subscale Impulsivity (I-7)
timeFrame: Change in I-7 from pre- to post-intervention (i.e. 8 week interval)
measure: Patient Health Questionnaire - 9 items depression module (PHQ-9)
timeFrame: Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval)
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: