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

NCT ID: NCT03372226

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2018-12-09

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.

Conditions

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Gambling, Pathologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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®.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Online self-help program

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Neustart

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steffen Moritz, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Gehlenborg J, Moritz S, Bucker 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. 2023 Mar;39(1):75-86. doi: 10.1007/s10899-022-10133-7. Epub 2022 May 28.

Reference Type DERIVED
PMID: 35633435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34158553 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30674348 (View on PubMed)

Other Identifiers

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Neustart

Identifier Type: -

Identifier Source: org_study_id

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