A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Corey R. Roos , Jonathan Bricker , Brian Kiluk , Timothy J. Trull , Sarah Bowen , Katie Witkiewitz , Hedy Kober
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引用次数: 0

Abstract

Background

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.

Methods

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.

Discussion

The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs.

Trial registration

ClinicalTrials.gov NCT05109507.

基于智能手机应用程序的正念干预,促进药物使用障碍的康复:试点可行性随机对照试验方案
背景在药物使用障碍(SUD)患者中,治疗后长期康复效果不佳(如再次入院治疗)的情况很常见。面对面的正念治疗(MBTs)对药物滥用性精神障碍(SUDs)具有疗效,并可改善康复结果。然而,现有的基于正念的治疗方法对公众健康的影响有限,因此需要可扩展的治疗方法。我们最近开发了 "心灵之旅"(Mindful Journey),这是一种基于智能手机应用程序的辅助性戒毒治疗方法,可改善长期康复效果。在本文中,我们将详细介绍该应用程序,并描述 "心灵之旅 "单点试点可行性随机对照试验的方案。在这项试验中,处于门诊治疗早期阶段的 SUD 患者(n = 34)将被随机分配到 "常规治疗"(TAU)加 "心灵之旅"(Mindful Journey)或 "常规治疗"(TAU)中。试验将重点测试应用程序的可行性(如参与度)和可接受性(如感知可用性和对康复的帮助),以及研究程序的可行性(如评估完成度)。试验将结合治疗前后的生态瞬间评估,以实时评估各种机制,包括正念、渴求、负面情绪调节困难和品味。为了检查结果(药物使用、药物相关问题和心理困扰)和机制变量(如上所述)变化的敏感性,我们将测试治疗条件内随着时间的推移而发生的变化。讨论拟议的试点试验将提供重要的初步数据,说明 "正念之旅 "在患有药物依赖性疾病的个体中是否可行和可接受。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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