Barnes Steven, Szastok Marta, Para Małgorzata, Morawiec Fabian, Grzeszczuk Maciej, Wójcik Szymon, Karpowicz Barbara, Zinevych Pavlo, Jaskulska Anna, Kopeć Wiesław, Kornacka Monika
Emotion Cognition Lab, SWPS University, Katowice, Poland.
XR Centre, Polish Japanese Academy of Information Technology, Warsaw, Poland.
JMIR Res Protoc. 2025 May 27;14:e66067. doi: 10.2196/66067.
Rumination is a transdiagnostic process present in several psychological disorders, involving repetitive negative thinking that individuals may perceive as difficult to control. While the roles of numerous mechanisms underlying rumination have been supported, experiential avoidance (EA) still lacks empirical backing, despite a strong theoretical foundation, partly due to difficulties in examining EA in an ecologically valid context. One promising approach to addressing this challenge is through reducing EA using mobile health (mHealth) and ecological momentary intervention (EMI), and assessing any subsequent decrease in rumination's deleterious outcomes.
This paper outlines the protocol for a randomized controlled trial using a novel mHealth EMI to address EA in the context of rumination. The app was developed by a multidisciplinary team, incorporating feedback from potential end users.
Consenting individuals (target N=60) who meet the inclusion criteria (self-reporting problems with repetitive negative thinking) will be randomly assigned to 1 of 4 conditions: (1) intervention with therapist support and daily sampling, (2) intervention without support and with daily sampling, (3) partial intervention (emotion validation EMI only) with daily sampling, or (4) control (daily sampling only). The intervention consists of a series of modules delivered over 4 weeks, with assessments conducted before and after intervention, and again at 1-month follow-up (plus an additional 3-month follow-up for intervention participants). Data will be collected both through online self-report assessments and via the app itself. The potential of the EMI to modify the maladaptive feature of repetitive negative thinking will be assessed using mixed-design ANOVA, while the links between avoidance-mood and rumination-mood, in terms of the moderating effect of trial condition, will be evaluated using multilevel models. These will be assessed as primary outcomes. Secondary outcomes are the effects of a supporting therapist on postintervention outcomes in the intervention groups, and time spent using the app as a measure of engagement (analyzed using the mixed-design analysis of covariance). Compliance will be defined as completing both of the first 2 weeks of intervention content in full, and 5 out of the 6 exercises from weeks 3 and 4. Additionally, the study will control for both the amount of time spent in the app and the length of responses to open-ended questions.
Recruitment and enrollment for the trial are expected to begin in May 2025 and be completed by July 2025. Data collection will conclude once the target sample size for each of the 4 conditions has been reached. The main results of the trial are expected to be submitted for publication in October 2025.
The outcomes of this research trial will not only provide insights into the clinical capabilities of the app, including its usability and acceptability in real-world contexts (and its potential future viability as a scalable product), but will also offer valuable theoretical insights into the role of EA in maladaptive rumination.
ClinicalTrials.gov NCT06570694; https://clinicaltrials.gov/ct2/show/NCT06570694.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/66067.
反刍思维是一种存在于多种心理障碍中的跨诊断过程，涉及个体可能认为难以控制的重复性消极思维。虽然支持反刍思维背后众多机制的作用，但经验性回避（EA）尽管有坚实的理论基础，仍缺乏实证支持，部分原因是在生态有效情境中检验EA存在困难。应对这一挑战的一种有前景的方法是通过移动健康（mHealth）和生态瞬时干预（EMI）来减少EA，并评估反刍思维有害后果随后的减少情况。
本文概述了一项随机对照试验的方案，该试验使用一种新型的mHealth EMI来解决反刍思维背景下的EA问题。该应用程序由一个多学科团队开发，并纳入了潜在最终用户的反馈。
符合纳入标准（自我报告存在重复性消极思维问题）的同意参与个体（目标样本量N = 60）将被随机分配到4种条件中的一种：（1）有治疗师支持和每日抽样的干预组，（2）无支持但有每日抽样的干预组，（3）仅进行部分干预（仅情绪验证EMI）且有每日抽样的组，或（4）对照组（仅每日抽样）。干预包括在4周内提供的一系列模块，在干预前后以及1个月随访时进行评估（干预参与者还将进行额外的3个月随访）。数据将通过在线自我报告评估和应用程序本身收集。将使用混合设计方差分析评估EMI改变重复性消极思维适应不良特征的潜力，同时使用多层次模型评估回避 - 情绪和反刍 - 情绪之间的联系，以及试验条件的调节作用。这些将作为主要结果进行评估。次要结果是支持性治疗师对干预组干预后结果的影响，以及使用应用程序的时间作为参与度的衡量指标（使用混合设计协方差分析进行分析）。依从性将定义为完全完成干预内容的前两周，以及第3周和第4周6项练习中的5项。此外，该研究将控制在应用程序中花费的时间以及对开放式问题的回答长度。
预计该试验的招募和入组将于2025年5月开始，并于2025年7月完成。一旦达到4种条件中每种条件的目标样本量，数据收集将结束。预计该试验的主要结果将于2025年10月提交发表。
这项研究试验的结果不仅将提供对该应用程序临床能力的见解，包括其在现实世界情境中的可用性和可接受性（以及其作为可扩展产品未来的潜在可行性），还将为EA在适应不良反刍思维中的作用提供有价值的理论见解。
ClinicalTrials.gov NCT06570694；https://clinicaltrials.gov/ct2/show/NCT06570694。
国际注册报告识别号（IRRID）：PRR1 - 10.2196/66067。
