Binkowska Alicja Anna, Obarska Katarzyna, Marcowski Przemysław, Szymczak Karol, Lewczuk Karol, Sollich Katarzyna, Banaszak Maria, Woronowicz Bohdan, Nowicka Małgorzata, Skorko Maciej, Gola Mateusz
PredictWatch, Upalna 1A/76, 15-668, Białystok, Poland.
DrugsTeam, NeuroCognitive Research Center, SWPS University of Social Sciences and Humanities, Warsaw, Poland.
Contemp Clin Trials Commun. 2023 Aug 6;36:101180. doi: 10.1016/j.conctc.2023.101180. eCollection 2023 Dec.
The prevalence of substance and behavioral addiction is estimated between 10 and 15% of the global population and remains a severe public health concern. Moreover, addiction treatment has several barriers, such as a lack of access to professional treatment or stigmatization. Mobile health interventions emerge as a promising solution.
This two-armed randomized controlled trial (RCT) aims to assess the efficacy of a mobile app-based self-guided psychological intervention delivered via a smartphone app (Nałogometr) in reducing craving and lapse risk in problematic behaviors and substance use compared to a control condition. Participant recruitment and data collection will start in June 2022 and end in September 2022. Due to the nature of the study, i.e., a nationwide study of problematic substance use and behaviors, we will aim to recruit all individuals willing to participate. The four-week intervention condition includes short-term and long-term modules based mainly on mindfulness and cognitive behavioral therapy. Longitudinal data on several variables related to craving and lapse risk are collected daily using ecological momentary assessment (EMA). The primary outcomes of interest will be the self-reported number of lapses and craving level in daily EMA. Moreover, a questionnaire battery assessment is administered at baseline in the first week following onboarding, after five weeks, and after six months. The secondary outcome measures will include the severity of problematic substance use or behaviors, anxiety and depression, and life satisfaction.
Results will be submitted for publication in peer-reviewed journals.
https://clinicaltrials.gov/], identifier [NCT054 34,429].
物质成瘾和行为成瘾的患病率估计在全球人口的10%至15%之间，仍然是一个严重的公共卫生问题。此外，成瘾治疗存在诸多障碍，例如难以获得专业治疗或受到污名化。移动健康干预措施成为一种有前景的解决方案。
这项双臂随机对照试验（RCT）旨在评估通过智能手机应用程序（Nałogometr）提供的基于移动应用程序的自我引导心理干预措施，与对照条件相比，在减少问题行为和物质使用中的渴望和复发风险方面的疗效。参与者招募和数据收集将于2022年6月开始，2022年9月结束。由于该研究的性质，即对全国范围内的问题物质使用和行为进行研究，我们的目标是招募所有愿意参与的个体。为期四周的干预条件包括主要基于正念和认知行为疗法的短期和长期模块。使用生态瞬时评估（EMA）每天收集与渴望和复发风险相关的几个变量的纵向数据。感兴趣的主要结果将是每日EMA中自我报告的复发次数和渴望程度。此外，在入职后的第一周、五周和六个月后，在基线时进行一系列问卷调查评估。次要结果指标将包括问题物质使用或行为的严重程度、焦虑和抑郁以及生活满意度。
结果将提交给同行评审期刊发表。
https://clinicaltrials.gov/，标识符 [NCT054 34,429]。
