Change4Better App for Gambling Addiction

(C4B Trial)

Recruiting at 3 trial locations

Overseen By Elizabeth Doohan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Untreated psychosis, Mania, Suicidal ideation, Opioid/alcohol dependence

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app called Change4Better (C4B) to determine if it reduces problem gambling more effectively than usual treatment methods. Participants will use the app to learn skills for managing gambling habits, spending about 8 hours on it over 12 weeks, with follow-up for another 12 weeks. The study seeks individuals who have gambled recently, meet specific criteria for gambling disorder, and are seeking or already receiving treatment. Participants must also own a smartphone with internet access. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatments for gambling disorders.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Change4Better app is safe for use in treating gambling addiction?

Research has shown that internet-based tools, such as the Change4Better (C4B) app, are generally safe and easy to use. Although specific safety data for the C4B app is not yet available, similar apps for gambling issues have not shown major side effects. Most users experience no problems with these apps.

The study lacks a specific phase label, indicating that the app's safety is not a significant concern. Digital tools like this often pose fewer risks than medications because they focus on teaching skills and changing habits, which typically do not cause harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Change4Better (C4B) app because it offers a novel, interactive way to tackle gambling addiction. Unlike traditional treatments, which typically involve in-person therapy sessions, C4B empowers users to manage their gambling habits through a mobile app that they can easily access at home. The app teaches cognitive skills specifically designed to address gambling-related thought patterns, offering a personalized, flexible approach to recovery. This digital method not only allows for more autonomy but also integrates seamlessly into users' daily lives, potentially enhancing engagement and long-term success.

What evidence suggests that the Change4Better app is effective for gambling addiction?

Research has shown that the Change4Better (C4B) app, available to participants in this trial, may help reduce gambling problems. The app incorporates techniques from cognitive behavioral therapy (CBT), which have successfully treated gambling issues. CBT changes how people think and act, reducing the urge to gamble and enhancing self-control. Early results suggest the app could be more effective when combined with standard treatments, as tested in this trial. It teaches skills for managing gambling and understanding how thoughts influence gambling behavior. Although more research is needed, initial studies are promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Brian Kiluk, PhD

Principal Investigator

Yale Universaity

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have a mild or greater gambling problem, can use English, gambled in the last month, and meet criteria for gambling disorder. They must be seeking or already getting treatment for gambling and own a smartphone with internet.

Inclusion Criteria

At least mild gambling severity as measured by GSAS (Total >8)

Able to speak, read, and write in English

Report gambling in the past month (28 days)

Exclusion Criteria

I am unable to understand or sign the consent form due to severe cognitive issues or inability to read.

Deemed to have current untreated psychosis or mania

Physical dependence on opioids and/or alcohol requiring medical detoxification

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Treatment As Usual (TAU) or TAU plus access to the Change4Better (C4B) mobile app for 12 weeks

12 weeks

Weekly visits (in-person or virtual)

Follow-up

Monthly follow-up to monitor app engagement and gambling symptom severity

12 weeks

Monthly visits (virtual)

Long-term follow-up

Participants are monitored for changes in gambling symptom severity from baseline to 6 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Change4Better (C4B)

Trial Overview The study tests if the Change4Better (C4B) mobile app helps reduce problem gambling severity more effectively than standard treatments. Participants will use the app and their progress will be compared to those receiving usual care.

How Is the Trial Designed?

Group I: Change4Better (C4B) app plus Treatment As Usual (TAU) Experimental Treatment 1 Intervention

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.

Group II: Treatment As Usual (TAU) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Mohegan Sun Problem Gambling Treatment Fund

Collaborator

Published Research Related to This Trial

The GAMBOT intervention, delivered through a messaging app, showed a significant reduction in gambling symptoms (G-SAS) among participants, indicating its potential effectiveness for problem gamblers, despite no significant change in the primary outcome (PGSI).

With a low dropout rate of only 6.7% and 77% of participants actively engaging throughout the 28-day intervention, GAMBOT demonstrates promise as a low-dropout alternative for problem gamblers who prefer not to seek face-to-face support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unguided Chatbot-Delivered Cognitive Behavioural Intervention for Problem Gamblers Through Messaging App: A Randomised Controlled Trial. So, R., Furukawa, TA., Matsushita, S., et al.[2021]

A randomized control trial is being conducted in New Zealand to evaluate the effectiveness and acceptability of a mobile app delivering cognitive behavioral therapy (CBT) for individuals with gambling problems, aiming to recruit 284 participants.

The app is designed to enhance user engagement through personalized features and multimedia elements, and it will measure changes in gambling symptoms and behaviors over 12 weeks, potentially improving access to treatment for those who typically do not seek help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manaaki - a cognitive behavioral therapy mobile health app to support people experiencing gambling problems: a randomized control trial protocol. Humphrey, G., Chu, J., Dowling, N., et al.[2020]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S107772292500104X

Change 4 Better (C4B): Development of a Mobile App ... The Change 4 Better (C4B) app was developed using the NIH Stage Model. Abstract. Gambling disorder (GD) is a significant public health problem, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06963931

Study Details | NCT06963931 | Change 4 Better (C4B) The purpose of this research study is to determine the effectiveness of the Change4Better (C4B) mobile app at reducing the severity of problem ...

3. ctv.veeva.com ctv.veeva.com/study/change-4-better-c4b

Change 4 Better (C4B) - ClinicalTrials.Veeva The purpose of this research study is to determine the effectiveness of the Change4Better (C4B) mobile app at reducing the severity of problem ...

4. withpower.com withpower.com/trial/phase-gambling-4-2025-3a11f

Change4Better App for Gambling Addiction (C4B Trial) Trial Overview The study tests if the Change4Better (C4B) mobile app helps reduce problem gambling severity more effectively than standard treatments.

5. researchgate.net researchgate.net/publication/396936637_Change_4_Better_C4B_Development_of_a_Mobile_App_Providing_Cognitive_Behavioral_Therapy_Skills_for_Gambling_Disorder

Change 4 Better (C4B): Development of a Mobile App ... Change 4 Better (C4B): Development of a Mobile App Providing Cognitive Behavioral Therapy Skills for Gambling ... Treatment outcomes in gambling ...

6. clinconnect.io clinconnect.io/trials/NCT06963931

Change 4 Better (C4B) (NCT06963931) - ClinConnect 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 ...