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通过行为助推提高远程医疗会话的保真度(BENEFITS):开发和试点测试一种改善认知行为疗法实施的远程医疗工具的方案

Behavioral Nudges to Enhance Fidelity in Telehealth Sessions (BENEFITS): Protocol for Developing and Pilot Testing a Telehealth Tool to Improve Cognitive Behavioral Therapy Implementation.

作者信息

Becker-Haimes Emily M, Mandell David S, Kuo Patty B, Lynch Kevin G, Brady Megan, Young Sophia, Creed Torrey A

机构信息

Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, United States.

出版信息

JMIR Res Protoc. 2025 Sep 18;14:e76035. doi: 10.2196/76035.

DOI:10.2196/76035
PMID:40966682
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12491885/
Abstract

BACKGROUND

The rapid expansion of telehealth provides a unique opportunity to integrate behavioral economics (BE) strategies into telehealth platforms to improve clinician fidelity to cognitive behavioral therapy (CBT)-either by enhancing clinicians' motivation to use CBT or by helping clinicians who are already motivated to act consistently on their intentions.

OBJECTIVE

We will develop and evaluate "Tele-BE," a novel telehealth platform designed to nudge and incentivize clinicians to use core structural components of CBT. We focus on these structural components because they align with practices most likely to benefit from BE strategies, are delivered across diagnoses, and represent CBT competencies independently linked to improved patient outcomes.

METHODS

We will refine the Tele-BE prototype in collaboration with clinicians and supervisors, who are the target end users (aim 1). Working closely with our web development team, we will field test and iteratively refine Tele-BE using rapid-cycle prototyping to optimize user experience and fine-tune the BE strategies (aim 2). The revised platform will then be evaluated in a 12-week open trial involving 30 community mental health clinicians, who will be randomized to either Tele-BE or telehealth as usual. Each clinician will deliver treatment to 2 patients, resulting in a total of 60 patient participants. All sessions will be recorded and coded to assess CBT fidelity. Clinicians and patients will complete questionnaires at weeks 1, 5, 9, and 12, with qualitative interviews conducted at the end of the trial. Primary outcomes will focus on fidelity to CBT structural components, measured via coding of recorded sessions. Secondary outcomes will include target implementation mechanisms-intentions and their determinants (attitudes, norms, and self-efficacy)-assessed using mixed methods, as well as overall CBT fidelity (aim 3). Additionally, trial data will be used to evaluate the acceptability and feasibility of Tele-BE from both patient and clinician perspectives, along with any potential ethical concerns associated with its use (aim 4).

RESULTS

The study received National Institute of Mental Health funding in June 2024. Recruitment for aim 1 began in October 2024. As of March 2025, 6 participants had been enrolled in the initial development stage. Recruitment is ongoing, and we anticipate completing aim 1 by May 2025, after which we will prepare for aim 2 activities. We aim to complete all study data collection by the end of 2026. In accordance with our grant award, deidentified data from aims 3 and 4 will be submitted to the National Institute of Mental Health Data Archive for participants who consent to data sharing.

CONCLUSIONS

Findings will provide insight into the utility of a BE-informed telehealth platform for increasing clinicians' use of core structural CBT components, thereby improving overall CBT fidelity and patient outcomes. Results will also inform the design of future confirmatory trials.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06601062; https://clinicaltrials.gov/ct2/show/NCT06601062.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/76035.

摘要

背景

远程医疗的迅速发展提供了一个独特的机会,可将行为经济学(BE)策略整合到远程医疗平台中,以提高临床医生对认知行为疗法(CBT)的忠诚度——要么通过增强临床医生使用CBT的动机,要么通过帮助那些已经有动机的临床医生按照他们的意图始终如一地采取行动。

目的

我们将开发并评估“远程行为经济学(Tele-BE)”,这是一个新型的远程医疗平台,旨在推动并激励临床医生使用CBT的核心结构组件。我们关注这些结构组件,是因为它们与最有可能从BE策略中受益的实践相一致,适用于各种诊断情况,并且代表了与改善患者治疗效果独立相关的CBT能力。

方法

我们将与作为目标最终用户的临床医生和督导合作,完善Tele-BE原型(目标1)。我们将与我们的网页开发团队密切合作,使用快速循环原型设计对Tele-BE进行实地测试并反复完善,以优化用户体验并微调BE策略(目标2)。然后,将在一项为期12周的开放试验中对修订后的平台进行评估,该试验涉及30名社区心理健康临床医生,他们将被随机分配到Tele-BE组或常规远程医疗组。每位临床医生将为2名患者提供治疗,总共将有60名患者参与。所有疗程都将被记录和编码,以评估CBT的忠诚度。临床医生和患者将在第1、5、9和12周完成问卷调查,并在试验结束时进行定性访谈。主要结果将集中在对CBT结构组件的忠诚度上,通过对记录疗程的编码来衡量。次要结果将包括目标实施机制——意图及其决定因素(态度、规范和自我效能感)——使用混合方法进行评估,以及整体CBT忠诚度(目标3)。此外,试验数据将用于从患者和临床医生的角度评估Tele-BE的可接受性和可行性,以及与其使用相关的任何潜在伦理问题(目标4)。

结果

该研究于2024年6月获得美国国立精神卫生研究所的资助。目标1的招募工作于2024年10月开始。截至2025年3月,已有6名参与者进入初始开发阶段。招募工作正在进行中,我们预计在2025年5月完成目标1,之后我们将为目标2的活动做准备。我们的目标是在2026年底前完成所有研究数据的收集。根据我们的资助协议,对于同意数据共享的参与者,目标3和目标4的去识别化数据将提交给美国国立精神卫生研究所数据存档库。

结论

研究结果将深入了解一个基于BE的远程医疗平台在增加临床医生使用CBT核心结构组件方面的效用,从而提高整体CBT忠诚度和患者治疗效果。结果还将为未来验证性试验的设计提供参考。

试验注册

ClinicalTrials.gov NCT06601062;https://clinicaltrials.gov/ct2/show/NCT06601062。

国际注册报告识别码(IRRID):DERR1-10.2196/76035。

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