Back to resultsDon't Go There: A Geospatial mHealth App for Gambling Disorder
Primary Purpose
Gambling Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth App
Sponsored by
About this trial
This is an interventional treatment trial for Gambling Disorder focused on measuring mHealth App
Eligibility Criteria
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.
Sites / Locations
- Saint Louis University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mHealth App
Wait List Control
Arm Description
Participants will receive the gambling disorder mHealth app.
Participant will be placed on a wait list for 12 weeks, after which they will be offered the gambling disorder mHealth app.
Outcomes
Primary Outcome Measures
App usage (feasibility)
Number of days the app is active on a user's smartphone. Days can range from 0 to 84.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04158037
First Posted
November 5, 2019
Last Updated
October 3, 2023
Sponsor
St. Louis University
Collaborators
National Center for Responsible Gaming
1. Study Identification
Unique Protocol Identification Number
NCT04158037
Brief Title
Don't Go There: A Geospatial mHealth App for Gambling Disorder
Official Title
Don't Go There: A Geospatial mHealth App for Gambling Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Louis University
Collaborators
National Center for Responsible Gaming
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gambling Disorder
Keywords
mHealth App
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mHealth App
Arm Type
Experimental
Arm Description
Participants will receive the gambling disorder mHealth app.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participant will be placed on a wait list for 12 weeks, after which they will be offered the gambling disorder mHealth app.
Intervention Type
Behavioral
Intervention Name(s)
mHealth App
Intervention Description
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.
Primary Outcome Measure Information:
Title
App usage (feasibility)
Description
Number of days the app is active on a user's smartphone. Days can range from 0 to 84.
Time Frame
From baseline to post-treatment (12 weeks)
Title
Patient satisfaction with the gambling app
Description
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.
Time Frame
From baseline to post-treatment (12 weeks)
Secondary Outcome Measure Information:
Title
Gambling behavior via Timeline Followback (Weinstock, Whelan, & Meyers, 2004)
Description
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.
Time Frame
From baseline to post-treatment (12 weeks)
Title
Gambling-related harms (Browne et al., 2018)
Description
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.
Time Frame
From baseline to post-treatment (12 weeks)
Title
Quality of Life Inventory (Frisch et al., 1994). A self-reported quality of life measure assessing 17 domains of life for importance and satisfaction.
Description
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.
Time Frame
From baseline to post-treatment (12 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeremiah Weintock, PhD
Phone
314-977-2137
Email
jeremiah.weinstock@health.slu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremiah Weinstock, PhD
Organizational Affiliation
St. Louis University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremiah Weinstock, PhD
Phone
314-977-2137
Email
jeremiah.weinstock@health.slu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Don't Go There: A Geospatial mHealth App for Gambling Disorder
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