NCT04158037

Brief 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. The project will conduct a 12-week pilot randomized clinical trial to test the short-term efficacy of the app with gambling disorder individuals.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 8, 2019

Completed
4.7 years until next milestone

Study Start

First participant enrolled

July 31, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

10 months

First QC Date

November 5, 2019

Last Update Submit

August 20, 2025

Conditions

Keywords

mHealth App

Outcome Measures

Primary Outcomes (2)

  • App usage (feasibility)

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

    From baseline to post-treatment (12 weeks)

  • 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.

    From baseline to post-treatment (12 weeks)

Secondary Outcomes (3)

  • Gambling behavior via Timeline Followback (Weinstock, Whelan, & Meyers, 2004)

    From baseline to post-treatment (12 weeks)

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

    From baseline to post-treatment (12 weeks)

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

    From baseline to post-treatment (12 weeks)

Study Arms (2)

mHealth App

EXPERIMENTAL

Participants will receive the gambling disorder mHealth app.

Behavioral: mHealth App

Wait List Control

NO INTERVENTION

Participant will be placed on a wait list for 12 weeks, after which they will be offered the gambling disorder mHealth app.

Interventions

mHealth AppBEHAVIORAL

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.

mHealth App

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63108, United States

Location

MeSH Terms

Conditions

Gambling

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental Disorders

Study Officials

  • Jeremiah Weinstock, PhD

    St. Louis University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 5, 2019

First Posted

November 8, 2019

Study Start

July 31, 2024

Primary Completion

May 31, 2025

Study Completion

June 1, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations