- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03372226
Computer-based Self-Help Program for People With Gambling Problems
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
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 Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS)
Time Frame: 1 week
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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.
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient Health Questionnaire - 9 depression module (PHQ-9)
Time Frame: 1 week
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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.
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1 week
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Gambling Attitudes and Beliefs Survey (GABS)
Time Frame: time of assessment
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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').
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time of assessment
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South Oaks Gambling Screen (SOGS)
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Steffen Moritz, Prof. Dr., Universitatsklinikum Hamburg-Eppendorf
Publications and helpful links
General Publications
- Gehlenborg J, Moritz S, Bücker 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. 2022 May 28. doi: 10.1007/s10899-022-10133-7. [Epub ahead of print]
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neustart
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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