Change 4 Better (C4B)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Change4Better (C4B) mobile app.
- Who it may be relevant to
- Registry conditions: Problem Gambling. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Change 4 Better (C4B): A Smartphone App to Address Problem Gambling
Overview
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.
Interventions
- Behavioral Change4Better (C4B) mobile app
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 dis
Primary outcome measures
- Change in gambling symptom severity [Time frame: Baseline to 6 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 6 centers
- Kindbridge Behavioral Health — Denver
- CommuniCare — New Haven
- Connecticut Renaissance — Norwalk
- United Community & Family Services — Norwich
- Wheeler Community Healthcare — Plainville
- MCCA — Waterbury
Identifiers
NCT: NCT06963931 · 2000039709