Computer-based Self-Help Program for People With Gambling Problems
28 april 2019 uppdaterad av: Universitätsklinikum Hamburg-Eppendorf
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
155
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Hamburg, Tyskland, 20246
- University Medical Center Hamburg-Eppendorf
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 70 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS)
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient Health Questionnaire - 9 depression module (PHQ-9)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Steffen Moritz, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 januari 2018
Primärt slutförande (Faktisk)
9 december 2018
Avslutad studie (Faktisk)
9 december 2018
Studieregistreringsdatum
Först inskickad
7 december 2017
Först inskickad som uppfyllde QC-kriterierna
12 december 2017
Första postat (Faktisk)
13 december 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 april 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 april 2019
Senast verifierad
1 april 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Neustart
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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