Change 4 Better (C4B)

ClinicalTrials.gov ID

NCT06963931

Lead Sponsor

Yale UniversityOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

128Estimated

Last Update Posted

May 22, 2026Actual

Start Date

May 1, 2025Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Dec 2027Estimated

Official Title

Change 4 Better (C4B): A Smartphone App to Address Problem Gambling

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 or Kindbridge Behavioral Health with locations across the US. 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 or Kindbridge Behavioral Health. Clinicians providing TAU within the Bettor Choice Programs or Kindbridge Behavioral Health 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.

• Problem Gambling

• Change4Better (C4B) mobile app

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 2 months (60 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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Yale UniversityOTHER

Collaborators

Mohegan Sun Problem Gambling Treatment FundUNKNOWN

elizabeth.doohan@yale.edu203-506-8043

elizabeth.doohan@yale.edu203-506-8043

• The Effect of a Brief Intervention for Problem Gamblers

  NCT04609007

  CompletedInterventionalNot ApplicableUpdated Oct 30, 2020
• Cognitive-Behavioral Treatment of Gambling

  NCT00118391

  CompletedInterventionalPhase 1Updated Jul 1, 2013
• Gambling and Brief Interventions

  NCT00183599

  CompletedInterventionalNot ApplicableUpdated Apr 9, 2019
• Developing and Testing a Brief Intervention for Problem Gambling in Credit Counseling

  NCT04064749

  CompletedInterventionalNot ApplicableUpdated Apr 10, 2024
• Effectiveness of Therapy Treatment

  NCT01596478

  Unknown statusInterventionalNot ApplicableUpdated Jan 11, 2017
• Cognitive Behavioral Treatments for Pathological Gambling

  NCT00618462

  CompletedInterventionalNot ApplicableUpdated Apr 9, 2019