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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04158037
Other study ID # 30494
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2025

Study information

Verified date March 2024
Source St. Louis University
Contact Jeremiah Weintock, PhD
Phone 314-977-2137
Email jeremiah.weinstock@health.slu.edu
Is FDA regulated No
Health authority
Study type Interventional

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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
mHealth App
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.

Locations

Country Name City State
United States Saint Louis University Saint Louis Missouri

Sponsors (2)

Lead Sponsor Collaborator
St. Louis University National Center for Responsible Gaming

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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 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. From baseline to post-treatment (12 weeks)
Secondary 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. From baseline to post-treatment (12 weeks)
Secondary 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. From baseline to post-treatment (12 weeks)
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