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

Trial Summary

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 data supports the effectiveness of the Change4Better treatment for gambling addiction?

The research on similar treatments, like the GAMBOT app, shows that using a messaging app with personalized feedback and cognitive behavioral techniques can help reduce gambling symptoms. Although the primary outcome wasn't significantly different, the secondary outcome showed improvement, suggesting that app-based interventions might be helpful for those who avoid face-to-face support. ^{1 2 3 4 5}

Is the Change4Better App safe for humans?

The research articles do not provide specific safety data for the Change4Better App, but they suggest that similar internet-based interventions for gambling and other conditions have been generally well-received and effective in reducing symptoms without reported safety concerns. ^{4 6 7 8 9}

How is the Change4Better App treatment for gambling addiction different from other treatments?

The Change4Better App is unique because it offers a digital, self-guided approach to treating gambling addiction, potentially overcoming barriers like reluctance to seek face-to-face help. It may incorporate elements like personalized feedback and cognitive behavioral therapy (CBT) principles, similar to other online interventions, but is specifically tailored for gambling issues. ^{1 5 9 10 11}

What is the purpose of this trial?

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).

Research Team

Brian Kiluk, PhD

Principal Investigator

Yale Universaity

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Unguided Chatbot-Delivered Cognitive Behavioural Intervention for Problem Gamblers Through Messaging App: A Randomised Controlled Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of community-based treatment for problem gambling: a quasi-experimental evaluation of cognitive-behavioral vs. twelve-step therapy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Developmental trajectories of gambling severity after cognitive-behavioral therapy. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a personalized feedback intervention for problem gamblers. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Predicting online problem gambling treatment discontinuation: New evidence from cross-validated models. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Pilot randomized controlled trial of an online intervention for problem gamblers. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial on a self-guided Internet-based intervention for gambling problems. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Manaaki - a cognitive behavioral therapy mobile health app to support people experiencing gambling problems: a randomized control trial protocol. [2020]

9. England pubmed.ncbi.nlm.nih.gov

A self-guided Internet-based intervention for individuals with gambling problems: study protocol for a randomized controlled trial. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Pilot study of a personalized feedback intervention for problem gamblers. [2022]

11. Hungary pubmed.ncbi.nlm.nih.gov

Online 8-week cognitive therapy for problem gamblers: The moderating effects of depression symptoms and perceived financial control. [2023]