Change 4 Better (C4B)
- Conditions
- Problem Gambling
- Registration Number
- NCT06963931
- Lead Sponsor
- Yale University
- Brief Summary
The purpose of this research study is to determine the effectiveness of the Change4Better (C4B) mobile app at reducing the severity of problem gambling as compared to standard treatment as usual (TAU).
- Detailed Description
This study is a 6-month randomized clinical trial for individuals with a gambling disorder enrolled in or seeking treatment for problem gambling at an outpatient treatment facilities affiliated with the Bettor Choice Gambling Treatment Programs in Connecticut. The purpose is to evaluate the feasibility and efficacy of a cognitive behavioral therapy-based mobile app (Change4Better; C4B), as an adjunct to treatment as usual (TAU) in community-based outpatient treatment programs. Eligible participants will be randomly assigned to receive either: (1) standard treatment as usual (TAU) or (2) TAU plus access to the Change4Better (C4B) mobile app. TAU will consist of standard services provided at outpatient clinics within the Bettor Choice Programs. Clinicians providing TAU within the Bettor Choice Program will not be participants in the research trial, and they will not be asked to perform any additional duties outside of their typical services. Participants assigned to C4B will receive TAU plus access to the C4B mobile app, which they can access as often as desired using their own device. The C4B mobile app will be managed by the Yale research team.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
- 18 years of age or older;
- able to speak, read and write in English;
- report gambling in the past month (28 days);
- meet DSM-5 criteria for gambling disorder within past 12 months as determined by the Structured Clinical Interview for Pathological Gambling - DSM-5 version (SCI-PG-DSM);
- at least mild gambling severity as measured by GSAS (Total >8)
- seeking or currently enrolled in treatment for gambling; if seeking treatment, must be deemed appropriate for outpatient level of care by treatment facility clinical team
- own a smartphone with internet access.
- unwilling or unable to provide informed consent due to severe cognitive impairment or inability to read;
- deemed to have current untreated psychosis or mania;
- active suicidal ideation;
- physical dependence on opioids and/or alcohol requiring medical detoxification.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in gambling symptom severity Baseline to 6 months Change in gambling symptom severity as measured monthly by the Gambling Symptom Assessment Scale (G-SAS) from baseline to 6 months. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48.
- Secondary Outcome Measures
Name Time Method App engagement-Days Used Randomization through week 12 Measured by number of days participants used the app
App engagement- Topics completed Randomization through week 12 Measured by number of topics completed by participants
App engagement- Practice exercises Randomization through week 12 Measured by number of practice exercises completed
App engagement- Weekly usage Randomization through week 12 Measured by average number of minutes per week participants used the app
App engagement- Total time Randomization through week 12 Measured by total time participants spent in the app
Trial Locations
- Locations (4)
CommuniCare
🇺🇸New Haven, Connecticut, United States
Connecticut Renaissance
🇺🇸Norwalk, Connecticut, United States
United Community & Family Services
🇺🇸Norwich, Connecticut, United States
MCCA
🇺🇸Waterbury, Connecticut, United States