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Gambling DisorderNCT04158037

Don't Go There: A Geospatial mHealth App for Gambling Disorder

A study testing mHealth App in people with Gambling Disorder, run by St. Louis University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of this project is to develop and to test the efficacy of a novel mHealth app for gambling disorder. The app capitalizes on smartphones' global positioning software (GPS) that recognizes a user's location to within 15 feet. Users will receive an alert of this go near a gambling venue. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gambling Disorder
What is being tested?
mHealth App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
31 Jul 2024to 1 Jun 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Currently meets DSM-5 criteria for gambling disorder
  • At least 4 non-online gambling episodes in past 60 days
  • Wagering at least $100 total over past 60 days
  • Willingness to accept random assignment
  • English speaking
  • Android phone user

Who cannot join

  • Age <18 years old
  • Severely disruptive behavior
  • Serious uncontrolled psychiatric behavior that requires acute psychiatric care
  • Decline permission to collect zero permission data from smartphone.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Saint Louis University

    St Louis, Missouri, 63108

Other trials in United States

About this study

The goal of this project is to develop and to test the efficacy of a novel mHealth app for gambling disorder. The app capitalizes on smartphones' global positioning software (GPS) that recognizes a user's location to within 15 feet. Users will receive an alert of this go near a gambling venue. The project will conduct a 12-week pilot randomized clinical trial to test the short-term efficacy of the app with gambling disorder individuals.

Being tested
mHealth App
Keywords
mHealth App
Medical subject headings
Gambling

What participants receive

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

  • mHealth AppBehavioural

    The app uses smartphones' global positioning software (GPS) that recognizes a user's location to within 15 feet. The app will construct a customizable geofence (e.g., 3 miles) around a gambler's favored gambling venue (e.g., casino, gas station). If the individual crosses the fence boundary his or her phone will raise the alarm with a personalized motivational message.

Study groups in NCT04158037
Study groupRoleWhat they receive
mHealth AppExperimentalParticipants will receive the gambling disorder mHealth app.
Receives: Behavioral: mHealth App
Wait List ControlNo interventionParticipant will be placed on a wait list for 12 weeks, after which they will be offered the gambling disorder mHealth app.

What is being measured

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

  1. App usage (feasibility)

    Number of days the app is active on a user's smartphone. Days can range from 0 to 84.

    Measured: From baseline to post-treatment (12 weeks)

  2. Patient satisfaction with the gambling app

    Investigator derived patient satisfaction self-report questionnaire. Five items, using a 7-point Likert scale from very dissatisfied (1) to very satisfied (7). Higher scores indicate a better outcome.

    Measured: From baseline to post-treatment (12 weeks)

Secondary outcomes (3)
  1. Gambling behavior via Timeline Followback (Weinstock, Whelan, & Meyers, 2004)

    Self-report gambling frequency and intensity as assessed by the Gambling Timeline Followback - a retrospective self-report calendar. Gambling frequency can range from 0 to 84; gambling intensity is measured in $ and time (hours). Dollars wagered can range from $0 to unlimited $. Time is measured in hours and can range from 0 to >1,000 hours. Higher scores indicate a worse outcome.

    Measured: From baseline to post-treatment (12 weeks)

  2. Gambling-related harms (Browne et al., 2018)

    Self-reported gambling harms as assessed by the 72-item Gambling-Related Harms Questionnaire (yes/no responses). Scores range from 0 to 72. Higher scores indicate a worse outcome.

    Measured: From baseline to post-treatment (12 weeks)

  3. Quality of Life Inventory (Frisch et al., 1994). A self-reported quality of life measure assessing 17 domains of life for importance and satisfaction.

    Self-report quality of life questionnaire. Participants rate 17 domains on importance (range not at all important [0] to extremely important [2]). The 17 domains are then rated on how satisfied the individual is regards to his or her life (-3 [very dissatisfied] to 3 [very dissatisfied]). A total score is then generated by summing the product of importance multiplied by satisfaction. Scores range from 0 to 102. Higher scores indicate a better outcome.

    Measured: From baseline to post-treatment (12 weeks)

Timeline

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

  1. First posted8 Nov 2019
  2. Study start31 Jul 2024
  3. Primary completion31 May 2025
  4. Study completion1 Jun 2025

Why it stopped: Technical difficulties with the mHealth app development

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04158037
Sponsor's protocol ID
30494
Status last verified
Aug 2025
First submitted
5 Nov 2019
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing mHealth App in people with Gambling Disorder, run by St. Louis University at 1 site in United States.

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 6 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Aug 2025. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.

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?

App usage (feasibility) (time frame: From baseline to post-treatment (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 27 Aug 2025.

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