帕金森氏症患者数字心理健康干预(PACT)的可接受性和可行性随机对照试验:试验方案。

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Cathryn Pinto, Jennie Brown, Catherine Hurt, Patricia Cubi-Molla, Sulayman Chowdhury, Lance McCracken, Sam Norton, Ricardo Volpato, Simone Stumpf, Angeliki Bogosian
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引用次数: 0

摘要

背景:由于症状负担和有限的心理服务可得性,帕金森病患者可经历心理困扰,难以获得面对面的心理支持。心理支持的数字选择可以弥补这一差距。我们开发了一款基于接受和承诺疗法(ACT)的应用程序,以帮助帕金森患者改善心理健康。目的:评估该应用程序的可接受性以及进行随机对照试验(RCT)的可行性,以评估使用该应用程序改善帕金森患者健康的有效性。方法:我们将进行一项平行组随机对照可行性试验,比较基于ACT的数字应用程序(干预组)和常规护理(等候名单对照组)。我们将招募60名帕金森患者,40人作为干预组,20人作为对照组。主要可行性结果包括招聘和留任率、干预参与度和满意度。次要结局包括临床效果(焦虑和抑郁)、生活质量和成本效益。将进行访谈以评估应用程序的可接受性。将对主要可行性结果数据进行描述性分析,并与预定义的可行性标准进行比较。次要结果将根据意向治疗原则进行分析,成本-后果分析将用于估计成本-效果。访谈将使用基于可接受性理论框架的演绎主题分析进行分析。讨论:该试验将提供数据,证明对该应用程序的有效性和成本效益进行全面随机对照试验的可行性,以改善帕金森病患者的心理健康。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Acceptability and feasibility randomised controlled trial of a digital mental health intervention for people with Parkinson's (PACT): trial protocol.

Acceptability and feasibility randomised controlled trial of a digital mental health intervention for people with Parkinson's (PACT): trial protocol.

Acceptability and feasibility randomised controlled trial of a digital mental health intervention for people with Parkinson's (PACT): trial protocol.

Acceptability and feasibility randomised controlled trial of a digital mental health intervention for people with Parkinson's (PACT): trial protocol.

Background: People with Parkinson's disease can experience psychological distress and have difficulties accessing face-to-face psychological support due to symptom burden and limited availability of psychological services. Digital options for psychological support can bridge this gap. We have developed an app based on acceptance and commitment therapy (ACT) to support people with Parkinson's to improve psychological wellbeing.

Aim: To assess the acceptability of the app and the feasibility of conducting a randomised controlled trial (RCT) to evaluate the effectiveness of using the app to improve wellbeing for people with Parkinson's.

Methods: We will conduct a parallel-group randomised controlled feasibility trial comparing a digital app based on ACT (intervention group) to usual care (waitlist control group). We will recruit 60 people with Parkinson's, 40 to the intervention group and 20 to the control group. Primary feasibility outcomes include recruitment and retention rate, intervention engagement and satisfaction. Secondary outcomes include measures of clinical effectiveness (anxiety and depression), quality of life and cost-effectiveness. Interviews will be conducted to assess acceptability of the app. Primary feasibility outcome data will be analysed descriptively and compared against pre-defined feasibility criteria. Secondary outcomes will be analysed based on an intention-to-treat principle, and a cost-consequence analysis will be used to estimate cost-effectiveness. Interviews will be analysed using a deductive thematic analysis based on the Theoretical Framework of Acceptability.

Discussion: This trial will provide data on the feasibility of conducting a full-scale RCT of the effectiveness and cost-effectiveness of the app to improve psychological wellbeing for people with Parkinson's disease.

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来源期刊
Pilot and Feasibility Studies
Pilot and Feasibility Studies Medicine-Medicine (miscellaneous)
CiteScore
2.70
自引率
5.90%
发文量
241
审稿时长
9 weeks
期刊介绍: Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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