Change 4 Better (C4B)

Yale University

Status: Enrolling

Conditions: Problem Gambling

Treatments: Behavioral: Change4Better (C4B) mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT06963931

2000039709

Details and patient eligibility

About

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).

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 2 patient groups

Change4Better (C4B) app plus Treatment As Usual (TAU)

Experimental group

Description:

Participants will work with a mobile app that teaches skills for managing gambling. They will learn skills that may help with cognitive distortions related to gambling - for example, how seemingly unrelated events might be related to gambling outcomes. Participants will be taught how to use the mobile app by a staff member and will be asked to spend about 8 hours using the program (approximately 30-45 minutes per module) at home and will be encouraged to complete over the course of 12 weeks. Monthly follow-up will occur for an additional 12 weeks at which time the mobile app will also be available to participants.

Treatment:

Behavioral: Change4Better (C4B) mobile app

Treatment As Usual (TAU)

No Intervention group

Description:

Treatment As Usual (TAU) will consist of standard services provided at outpatient clinics within the Bettor Choice Programs. TAU will be tailored to the participants needs, and generally includes individual and/or group therapy sessions. Sessions will generally last for 1 hour one time per week for the first 12 weeks and include issues such as: * Teaching about the treatment program at the clinic * Teaching important ideas about recovery * Increasing knowledge about specific problems participants may have about with gambling * Demonstrating new ways of coping with skills designed to fit participants lifestyle.