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Gambling, PathologicNCT03372226

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

A study testing Online self-help program in people with Gambling, Pathologic, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gambling, Pathologic
What is being tested?
Online self-help program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
1 siteGermany
Study dates
18 Jan 2018to 9 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

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.

Read the detailed description

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.

Being tested
Online self-help program
Keywords
Gambling, Problematic Gambling, Pathological Gambling
Medical subject headings
Gambling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online self-help programBehavioural

    Also called Neustart

    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.

Study groups in NCT03372226
Study groupRoleWhat they receive
Online self-help programExperimentalThe 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.
Receives: Behavioral: Online self-help program
Wait-list control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS)

    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.

    Measured: 1 week

Secondary outcomes (3)

  1. Patient Health Questionnaire - 9 depression module (PHQ-9)

    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.

    Measured: 1 week

  2. Gambling Attitudes and Beliefs Survey (GABS)

    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').

    Measured: time of assessment

  3. South Oaks Gambling Screen (SOGS)

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2017
  2. Study start18 Jan 2018
  3. Primary completion9 Dec 2018
  4. Study completion9 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03372226
Sponsor's protocol ID
Neustart
Status last verified
Apr 2019
First submitted
7 Dec 2017
Last updated
30 Apr 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 35633435

  • 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.

    PubMed 34158553

  • 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.

    PubMed 30674348

Questions about this trial

What is this clinical trial studying?

A study testing Online self-help program in people with Gambling, Pathologic, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS) (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03372226, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.

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