Change 4 Better (C4B)

NCT06963931 | Recruiting DMC

• 1 other identifier: 2000039709
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

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).

Conditions

Problem Gambling

Keywords

Problem gambling; mobile app

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 6 months

Secondary Outcomes (5)

• App engagement-Days Used

  Randomization through week 12

• App engagement- Topics completed

  Randomization through week 12

• App engagement- Practice exercises

  Randomization through week 12

• App engagement- Weekly usage

  Randomization through week 12

• App engagement- Total time

  Randomization through week 12

Study Arms (2)

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.

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. 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.

Interventions

Change4Better (C4B) mobile app BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older;
• able to speak, read and write in English;
• report gambling in the past month (28 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Mohegan Sun Problem Gambling Treatment Fund: collaborator

Study Sites (4)

CommuniCare

New Haven, Connecticut, 06511, United States

RECRUITING

Connecticut Renaissance

Norwalk, Connecticut, 06852, United States

RECRUITING

United Community & Family Services

Norwich, Connecticut, 06360, United States

RECRUITING

MCCA

Waterbury, Connecticut, 06710, United States

RECRUITING

Study Officials

• Brian Kiluk, PhD

  Yale Universaity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Doohan

CONTACT

203-506-8043; elizabeth.doohan@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)