Change 4 Better (C4B)
ConditionProblem Gambling
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Change4Better (C4B) mobile app
BehavioralThe 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
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Change4Better (C4B) app plus Treatment As Usual (TAU)Experimental treatment 1 intervention
Group B: Treatment As Usual (TAU)No intervention 0 interventions
Trial outcomes
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.
Time frame
Baseline to 6 monthsSecondary outcomes
1
App engagement-Days Used
Measured by number of days participants used the app
Time frame
Randomization through week 122
App engagement- Topics completed
Measured by number of topics completed by participants
Time frame
Randomization through week 123
App engagement- Practice exercises
Measured by number of practice exercises completed
Time frame
Randomization through week 124
App engagement- Weekly usage
Measured by average number of minutes per week participants used the app
Time frame
Randomization through week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Mohegan Sun Problem Gambling Treatment Fund
Collaborator
Source ClinicalTrials.gov