Computer-based Self-Help Program for People With Gambling Problems

Study Overview
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Brief Summary
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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
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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.

Official Title
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Computer-based Self-Help Program for People With Gambling Problems

Conditions
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Gambling, Pathologic

Intervention / Treatment
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* Behavioral: Online self-help program


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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®.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online self-help program<br>The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 10 modules with many interactional exercises and homework-sheets. Themes that are addressed in the online-program are for example self-esteem, sleep hygiene, problem solving strategies, mindfulness-based relaxation and attention exercises as well as gambling-specific topics such as money/debt management and impulse control. In addition, the user learns to modify negative and gambling-specific thought distortions, to integrate positive activities into his/her daily routine, strategies to deal with the urge to play as well as ways to regulate debts and to prevent relapse. | Behavioral: Online self-help program<br>* The program consists of 10 modules with many interactional exercises and homework-sheets. Themes that are addressed in the online-program are for example self-esteem, sleep hygiene, problem solving strategies, mindfulness-based relaxation and attention exercises as well as gambling-specific topics such as money/debt management and impulse control. In addition, the user learns to modify negative and gambling-specific thought distortions, to integrate positive activities into his/her daily routine, strategies to deal with the urge to play as well as ways to regulate debts and to prevent relapse.<br>* Other names: Neustart;|
| No Intervention: Wait-list control group<br>The participants of the wait-list control condition do not receive any new intervention during the intervention period of 8 weeks, but may continue any treatment that has already been started before, including medication. Participants in the wait-list control condition receive full access to the program after completion of the post-assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 α = .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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gambling, Problematic Gambling, Pathological Gambling