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评估基于视频的互联网干预作为住院身心康复准备的效果:一项随机对照试验的研究方案

Evaluation of a video-based Internet intervention as preparation for inpatient psychosomatic rehabilitation: study protocol for a randomized controlled trial.

作者信息

Becker Jan, Beutel Manfred E, Gerzymisch Katharina, Schulz Dirk, Siepmann Martin, Knickenberg Rudolf J, Schmädeke Stefan, Ferdinand Peter, Zwerenz Rüdiger

机构信息

Department of Psychosomatic Medicine and Psychotherapy, University Medical Center of the Johannes Gutenberg-University, Untere Zahlbacher Str. 8, 55131, Mainz, Germany.

Media Center of the Johannes Gutenberg-University Mainz, Wallstraße 11, 55122, Mainz, Germany.

出版信息

Trials. 2016 Jun 13;17(1):287. doi: 10.1186/s13063-016-1417-y.

DOI:10.1186/s13063-016-1417-y
PMID:27296249
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4906995/
Abstract

BACKGROUND

Patients' treatment expectations are a key factor in psychotherapy. Several studies have linked higher expectations to better treatment success. Therefore, we want to evaluate the impact of a targeted video-based intervention on patients' expectations and the treatment success of inpatient rehabilitation.

METHODS/DESIGN: All patients who will be referred to inpatient psychosomatic rehabilitation in three clinics will receive a study flyer with information about how to log in to the study platform together with the usual clinic information leaflet. Patients will receive the study information and informed consent upon login and will be randomized into the intervention or the control group. The intervention group (n = 394) will get access to our virtual online clinic, containing several videos about inpatient rehabilitation, until their admission to inpatient rehabilitation. The control group (n = 394) will receive no special treatment preparation. Questionnaires will be given at study inclusion (T0), two weeks before admission to (T1), and at the end of (T2) inpatient rehabilitation. The primary outcome is the outcome expectancy measured with the Credibility Expectancy Questionnaire at T1. Secondary outcomes include treatment motivation, mental health, work ability, depression, anxiety, and satisfaction with and usage of the Internet platform.

DISCUSSION

We expect the intervention group to benefit from the additional preparation concerning their outcome expectancy. If successful, this approach could be used in the future to enhance the efficacy of inpatient rehabilitation.

TRIAL REGISTRATION

ClinicalTrials.gov: NCT02532881 . Registered on 25 August 2015.

摘要

背景

患者的治疗期望是心理治疗中的一个关键因素。多项研究已将更高的期望与更好的治疗效果联系起来。因此,我们想评估一种基于视频的针对性干预对患者期望以及住院康复治疗效果的影响。

方法/设计:将被转介到三家诊所进行住院身心康复治疗的所有患者,在收到包含常规诊所信息传单的同时,还将收到一份关于如何登录研究平台的研究传单。患者登录时将收到研究信息并签署知情同意书,然后被随机分为干预组或对照组。干预组(n = 394)在入院接受住院康复治疗之前,可访问我们的虚拟在线诊所,其中包含几段关于住院康复的视频。对照组(n = 394)将不接受特殊的治疗准备。在研究纳入时(T0)、入院前两周(T1)以及住院康复结束时(T2)发放问卷。主要结局是在T1时用可信度期望问卷测量的结局期望。次要结局包括治疗动机、心理健康、工作能力、抑郁、焦虑以及对互联网平台的满意度和使用情况。

讨论

我们预计干预组将从有关其结局期望的额外准备中受益。如果成功,这种方法未来可用于提高住院康复的疗效。

试验注册

ClinicalTrials.gov:NCT02532881。于2015年8月25日注册。

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