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

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ClinicalTrials.gov Identifier: NCT03372226
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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 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.

Condition or disease Intervention/treatment Phase
Gambling, Pathologic Behavioral: Online self-help program Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer-based Self-Help Program for People With Gambling Problems
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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.

Behavioral: 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.
Other Name: Neustart

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.



Primary Outcome Measures :
  1. Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-Y-BOCS) [ Time Frame: 1 week ]
    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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire - 9 depression module (PHQ-9) [ Time Frame: 1 week ]
    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.

  2. Gambling Attitudes and Beliefs Survey (GABS) [ Time Frame: time of assessment ]
    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').

  3. South Oaks Gambling Screen (SOGS) [ Time Frame: 6 months ]
    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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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372226


Contacts
Contact: Lara Buecker, M.Sc. 0049741053417 l.buecker@uke.de
Contact: Steffen Moritz, Prof. Dr. 0049741056565 moritz@uke.de

Locations
Germany
University Medical Center Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Lara Bücker, M.Sc.    0049 40 7410 53417    l.buecker@uke.de   
Contact: Steffen Moritz, Prof. Dr.    0049 40 7410 56565    moritz@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Principal Investigator: Steffen Moritz, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03372226     History of Changes
Other Study ID Numbers: Neustart
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Gambling
Problematic Gambling
Pathological Gambling

Additional relevant MeSH terms:
Gambling
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders