- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03372226
Computer-based Self-Help Program for People With Gambling Problems
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Hamburg, Deutschland, 20246
- University Medical Center Hamburg-Eppendorf
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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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.
Andere Namen:
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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Patient Health Questionnaire - 9 depression module (PHQ-9)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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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Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Steffen Moritz, Prof. Dr., Universitatsklinikum Hamburg-Eppendorf
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Neustart
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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