Problem GamblingC4BNCT06963931
Change 4 Better (C4B)
A study testing Change4Better (C4B) mobile app in people with Problem Gambling, run by Yale University at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Gambling
- What is being tested?
- Change4Better (C4B) mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older;
- able to speak, read and write in English;
- report gambling in the past 2 months (60 days);
- 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);
- at least mild gambling severity as measured by GSAS (Total >8)
- 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
- own a smartphone with internet access.
Who cannot join
- unwilling or unable to provide informed consent due to severe cognitive impairment or inability to read;
- deemed to have current untreated psychosis or mania;
- active suicidal ideation;
- physical dependence on opioids and/or alcohol requiring medical detoxification.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Kindbridge Behavioral Health
Denver, Colorado, 80237
Elizabeth Doohan, 203-506-8043, elizabeth.doohan@yale.edu
- Recruiting
CommuniCare
New Haven, Connecticut, 06511
Elizabeth Doohan, 203-506-8043, elizabeth.doohan@yale.edu
- Recruiting
Connecticut Renaissance
Norwalk, Connecticut, 06852
Elizabeth Doohan, 203-506-8043, elizabeth.doohan@yale.edu
- Recruiting
United Community & Family Services
Norwich, Connecticut, 06360
Elizabeth Doohan, 203-506-8043, elizabeth.doohan@yale.edu
- Recruiting
Wheeler Community Healthcare
Plainville, Connecticut, 06062
Elizabelth Doohan, 203-506-8043, elizabeth.doohan@yale.edu
- Recruiting
MCCA
Waterbury, Connecticut, 06710
Elizabeth Doohan, 203-506-8043, elizabeth.doohan@yale.edu
About this study
Official title: Change 4 Better (C4B): A Smartphone App to Address Problem Gambling
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).
Read the 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.
- Conditions
- Problem Gambling
- Being tested
- Change4Better (C4B) mobile app
- Keywords
- Problem gambling, mobile app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change4Better (C4B) mobile appBehavioural
The content of the C4B app is designed to teach key CBT strategies to address gambling behaviors. The content targets concerns that people with gambling problems often experience (gambling debts, cognitive distortions related to gambling - for example, how unrelated events might be related to gambling outcomes). We have designed the content such that people using the app can see the pattern of progress, identify mistakes and setbacks, and learn from common experiences of people with gambling disorder
| Study group | Role | What they receive |
|---|---|---|
| Change4Better (C4B) app plus Treatment As Usual (TAU) | Experimental | 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. Receives: Behavioral: Change4Better (C4B) mobile app |
| Treatment As Usual (TAU) | No intervention | Treatment As Usual (TAU) will consist of standard services provided at outpatient clinics within the Bettor Choice Programs or Kindbridge Behavioral Health. 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gambling symptom severity
Change in gambling symptom severity as measured monthly by the Gambling Symptom Assessment Scale (G-SAS) from baseline to 6 months. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48.
Measured: Baseline to 6 months
Secondary outcomes (5)
App engagement-Days Used
Measured by number of days participants used the app
Measured: Randomization through week 12
App engagement- Topics completed
Measured by number of topics completed by participants
Measured: Randomization through week 12
App engagement- Practice exercises
Measured by number of practice exercises completed
Measured: Randomization through week 12
App engagement- Weekly usage
Measured by average number of minutes per week participants used the app
Measured: Randomization through week 12
App engagement- Total time
Measured by total time participants spent in the app
Measured: Randomization through week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 May 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem GamblingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Mohegan Sun Problem Gambling Treatment Fund
- Responsible party
- Sponsor
- Investigators
- Brian Kiluk, PhD, Principal investigator, Yale Universaity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963931
- Sponsor's protocol ID
- 2000039709
- Acronym
- C4B
- Status last verified
- May 2026
- First submitted
- 1 May 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change 4 Better (C4B): A Smartphone App to Address Problem Gambling
- ClinicalTrials.gov ID
- NCT06963931
- Acronym / sponsor ID
- C4B / 2000039709
- Conditions
- Problem Gambling
- Keywords
- Problem gambling, mobile app
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Mohegan Sun Problem Gambling Treatment Fund
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Change4Better (C4B) app plus Treatment As Usual (TAU) | Experimental | Behavioral: Change4Better (C4B) mobile appParticipants 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 As Usual (TAU) | No intervention | –Treatment As Usual (TAU) will consist of standard services provided at outpatient clinics within the Bettor Choice Programs or Kindbridge Behavioral Health. 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older;
- able to speak, read and write in English;
- report gambling in the past 2 months (60 days);
- 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);
- at least mild gambling severity as measured by GSAS (Total >8)
Key exclusion criteria (4 listed)
- unwilling or unable to provide informed consent due to severe cognitive impairment or inability to read;
- deemed to have current untreated psychosis or mania;
- active suicidal ideation;
- physical dependence on opioids and/or alcohol requiring medical detoxification.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change4Better (C4B) mobile appThe content of the C4B app is designed to teach key CBT strategies to address gambling behaviors. The content targets concerns that people with gambling problems often experience (gambling debts, cognitive distortions related to gambling - for example, how unrelated events might be related to gambling outcomes). We have designed the content such that people using the app can see the pattern of progress, identify mistakes and setbacks, and learn from common experiences of people with gambling disorder | Behavioural | Change4Better (C4B) app plus Treatment As Usual (TAU) |
Primary outcome
Change in gambling symptom severity
Time frame: Baseline to 6 months
Change in gambling symptom severity as measured monthly by the Gambling Symptom Assessment Scale (G-SAS) from baseline to 6 months. Each item is scored on a 5-point scale from 0 (no symptoms) to 4 (extreme symptoms). The total score ranges from 0 to 48.
5 secondary outcomes
App engagement-Days Used
Time frame: Randomization through week 12
App engagement- Topics completed
Time frame: Randomization through week 12
App engagement- Practice exercises
Time frame: Randomization through week 12
App engagement- Weekly usage
Time frame: Randomization through week 12
App engagement- Total time
Time frame: Randomization through week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Kiluk, PhD principal investigator
Yale Universaity
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change4Better (C4B) mobile app in people with Problem Gambling, run by Yale University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Doohan (203-506-8043, elizabeth.doohan@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gambling symptom severity (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.