Change 4 Better (C4B)

Официальное название

Change 4 Better (C4B): A Smartphone App to Address Problem Gambling

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Change in gambling symptom severity [Срок оценки: Baseline to 6 months]

Вторичные конечные точки (5)

• App engagement-Days Used [Срок оценки: Randomization through week 12]
• App engagement- Topics completed [Срок оценки: Randomization through week 12]
• App engagement- Practice exercises [Срок оценки: Randomization through week 12]
• App engagement- Weekly usage [Срок оценки: Randomization through week 12]
• App engagement- Total time [Срок оценки: Randomization through week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 6 центров

• Kindbridge Behavioral Health — Denver
• CommuniCare — New Haven
• Connecticut Renaissance — Norwalk
• United Community & Family Services — Norwich
• Wheeler Community Healthcare — Plainville
• MCCA — Waterbury

Идентификаторы

NCT: NCT06963931 · 2000039709

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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