Clinical trial NCT06963931: Change 4 Better (C4B)
Official title: Change 4 Better (C4B): A Smartphone App to Address Problem Gambling
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Problem Gambling
Keywords: Problem gambling
mobile app
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Mohegan Sun Problem Gambling Treatment Fund
First posted: 2025-05-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older;
2. able to speak, read and write in English;
3. report gambling in the past month (28 days);
4. 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);
5. at least mild gambling severity as measured by GSAS (Total \>8)
6. 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
7. own a smartphone with internet access.

Exclusion Criteria:

1. unwilling or unable to provide informed consent due to severe cognitive impairment or inability to read;
2. deemed to have current untreated psychosis or mania;
3. active suicidal ideation;
4. physical dependence on opioids and/or alcohol requiring medical detoxification.

Primary outcomes:
measure: Change in gambling symptom severity
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: App engagement-Days Used
timeFrame: Randomization through week 12
measure: App engagement- Topics completed
timeFrame: Randomization through week 12
measure: App engagement- Practice exercises
timeFrame: Randomization through week 12
measure: App engagement- Weekly usage
timeFrame: Randomization through week 12
measure: App engagement- Total time
timeFrame: Randomization through week 12
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CommuniCare
state: Connecticut
city: Norwalk
country: United States
facility: Connecticut Renaissance
state: Connecticut
city: Norwich
country: United States
facility: United Community & Family Services
state: Connecticut
city: Waterbury
country: United States
facility: MCCA
state: Connecticut
Study officials:
affiliation: Yale Universaity
name: Brian Kiluk, PhD
role: PRINCIPAL_INVESTIGATOR
References: