Computer-based Self-Help Program for People With Gambling Problems
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|ClinicalTrials.gov Identifier: NCT03372226|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gambling, Pathologic||Behavioral: Online self-help program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|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®.
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Computer-based Self-Help Program for People With Gambling Problems|
|Actual Study Start Date :||January 18, 2018|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Experimental: Online self-help program
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
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.
Other Name: Neustart
No Intervention: Wait-list control group
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.
- Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS) [ Time Frame: 1 week ]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.
- Patient Health Questionnaire - 9 depression module (PHQ-9) [ Time Frame: 1 week ]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.
- Gambling Attitudes and Beliefs Survey (GABS) [ Time Frame: time of assessment ]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').
- South Oaks Gambling Screen (SOGS) [ Time Frame: 6 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372226
|Contact: Lara Buecker, M.Sc.||firstname.lastname@example.org|
|Contact: Steffen Moritz, Prof. Dr.||email@example.com|
|University Medical Center Hamburg-Eppendorf||Recruiting|
|Hamburg, Germany, 20246|
|Contact: Lara Bücker, M.Sc. 0049 40 7410 53417 firstname.lastname@example.org|
|Contact: Steffen Moritz, Prof. Dr. 0049 40 7410 56565 email@example.com|
|Principal Investigator:||Steffen Moritz, Prof. Dr.||Universitätsklinikum Hamburg-Eppendorf|