App for Reducing Cravings to Smoke

Официальное название

Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation

Обзор

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

Подробное описание

The aims of the study are: (1) to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction; and (2) to test in a randomized controlled trial the efficacy of the app as an adjunct to quitline smoking cessation treatment in improving smoking abstinence compared to the quitline only.

Вмешательства

• Поведенческое Updating Existing Smartphone App
  Participants will be asked to use a recently developed study smartphone application to reduce cravings to smoke for a 5-week period. Through the app, participants will be exposed to smoking extinction trials daily. Participants will be encouraged and reminded to complete 2-5 extinction sessions per day. Each session will present 3-8 cues, and each cue will be presented for 20-40 seconds (average amount of extinction per day will be about 10 minutes). Participants will be encouraged to conduct th
• Поведенческое Quitline Services
  Quitline coaches use cognitive behavioral therapy, reinforcement, and principles of self-efficacy to promote effective behavior change. The quitline approach includes 5 key elements: setting a quit date, coping with triggers, effectively using medications, tobacco proofing, and social support. Individuals who enroll in the quitline's multi-call program receive phone calls and NRT.
• Поведенческое Quitline Services and Smartphone App
  In addition to quitline services, participants will download a study app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, those in the intervention group will be exposed to smoking extinction trials through the study smartphone app.

Первичные конечные точки

• System Usability Scale (Aim 1) [Срок оценки: At 1 Week]
• Tobacco Abstinence (Aim 2) [Срок оценки: At 6 Months]

Вторичные конечные точки (1)

• User Satisfaction (Aim 1) [Срок оценки: At 1 Week]

Критерии участия

Критерии включения

• >18 years of age
• Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)
• Functioning telephone number
• Owns a smart phone capable of supporting AR and willing to download the app
• Can speak, read and write in English

Критерии исключения

• Has another household member already enrolled in the study

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Moffitt Cancer Center — Tampa

Публикации

• Poudel R, Dougan SO, Yates H, Sawyer L, Martinez U, Brandon KO, Sutton SK, Vidrine DJ, Ritterband LM, Wiseman KP, Vickerman KA, Turner K, Byrne MM, Yang MJ, Horta M, Brandon TH, Vinci C. Using augmented reality to deliver cue exposure treatment for smoking cessation: App usability findings and protocol for a randomized controlled trial. Contemp Clin Trials. 2025 Mar;150:107827. doi: 10.1016/j.cct. PMID 39880329

Идентификаторы

NCT: NCT06088498 · MCC-21980 Aim 2 · R01DA055298

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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