Roos Corey R, Bricker Jonathan, Kiluk Brian, Trull Timothy J, Bowen Sarah, Witkiewitz Katie, Kober Hedy
Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
Fred Hutch Cancer Center, Seattle, WA, USA.
Contemp Clin Trials Commun. 2024 Jul 26;41:101338. doi: 10.1016/j.conctc.2024.101338. eCollection 2024 Oct.
Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise.
We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time.
The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs.
ClinicalTrials.gov NCT05109507.
物质使用障碍（SUDs）患者治疗后的长期康复效果不佳（如再次住院治疗）很常见。基于面对面的正念疗法（MBTs）对SUDs有效，可能会改善康复效果。然而，现有的针对SUDs的MBTs在公共卫生领域的覆盖范围有限，因此需要可扩展的交付方法。一种数字化交付的针对SUDs的MBT可能具有前景。
我们最近开发了“正念之旅”，这是一款基于智能手机应用程序的辅助MBT，用于改善长期康复效果。在本文中，我们详细介绍了该应用程序，并描述了一项针对“正念之旅”的单中心试点可行性随机对照试验方案。在该试验中，处于SUDs门诊治疗早期阶段的个体（n = 34）将被随机分为常规治疗（TAU）加“正念之旅”组或仅TAU组。该试验将侧重于测试该应用程序的可行性（如参与度）和可接受性（如对康复的感知可用性和帮助性），以及研究程序的可行性（如评估完成情况）。该试验将在治疗前后纳入生态瞬时评估，以实时评估机制，包括正念、渴望、负面情绪调节困难和品味。为了检验结果（物质使用、与物质相关的问题和心理困扰）和机制变量（如上所述）对变化的敏感性，我们将测试治疗条件内随时间的变化。
拟议的试点试验将提供关于“正念之旅”在SUDs个体中是否可行和可接受的重要初步数据。
ClinicalTrials.gov NCT05109507。
