NCT03460288

Brief Summary

The study examines the efficacy and acceptance of a computer-based training program for individuals with problematic or pathological gambling behavior. The study intends to investigate the extent to which the computer-based training program leads to a significant reduction in pathological gambling (primary outcome) when compared to a control group. The study design is a randomized-controlled trial with one intervention group and one wait-list control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2018

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

11 months

First QC Date

February 5, 2018

Last Update Submit

April 28, 2019

Conditions

Keywords

Gambling, Problematic Gambling, Pathological Gambling

Outcome Measures

Primary Outcomes (1)

  • Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)

    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.

    Change in PG-YBOCS from pre- to post-intervention (i.e. 8 week interval)

Secondary Outcomes (3)

  • South Oaks Gambling Screen (SOGS)

    Change in SOGS from pre- to post-intervention (i.e. 8 week interval)

  • Eysenck Impulsiveness Questionnaire - Subscale Impulsivity (I-7)

    Change in I-7 from pre- to post-intervention (i.e. 8 week interval)

  • Patient Health Questionnaire - 9 items depression module (PHQ-9)

    Change in PHQ-9 from pre- to post-intervention (i.e. 8 week interval)

Study Arms (2)

Intervention Group

EXPERIMENTAL

The training-program includes ten pictures related to slot-machine gambling and 10 neutral pictures that need to be either pushed (i.e., avoidance) or pulled (i.e., approach) with the computer mouse or finger (when a tablet is used) according to a non-affective dimension (color of the frame). Pictures are presented in random order.

Behavioral: Retraining (AAT)

Wait-list control group

NO INTERVENTION

The participants of the wait-list control condition do not receive the retraining intervention during the intervention period of 8 weeks, but may continue any treatment that has already been started before, including pharmacological treatment. Participants in the wait-list control condition receive full access to the training program after completion of the post-assessment.

Interventions

The training program is based upon the approach-avoidance task (AAT) and can be easily performed on a computer, laptop or tablet. There is a total of 20 pictures, 10 slot-machine gambling related pictures and 10 neutral pictures that were already used in a prior study (Wittekind et al., submitted). The pictures appear on the computer screen and have to be either pushed or pulled. Pushing and pulling depends on a masked instruction (not related to the content of the pictures, but to the color of the frame). All gambling-related pictures are framed with the color that is instructed to be pushed, all neutral pictures are framed with the color that is instructed to be pulled.

Intervention Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • access to internet
  • sufficient command of the 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 who do not use the program are also included in the analysis)
  • willingness to leave an (anonymous) email-address
  • subjective need for treatment

You may not qualify if:

  • presence of a lifetime diagnosis of schizophrenia or bipolar disorder
  • acute suicidal tendency (assessed with item 9 of the PHQ-9, ≥3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Steffen Moritz, Prof. Dr.

    Universitätsklinikum Hamburg-Eppendorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is a randomly controlled study with 2 conditions: Condition 1: Computer-based training program (retraining), condition 2: Wait-list control group (access to the training after the post-assessment). Two assessments-points, the intervention period (pre-post) is eight weeks. Sociodemographic and pathological data are obtained with an internet survey on Unipark®.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2018

First Posted

March 9, 2018

Study Start

January 18, 2018

Primary Completion

December 11, 2018

Study Completion

December 11, 2018

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations