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蜘蛛恐惧症患者在暴露于引发恐惧的刺激物期间进行心率变异性生物反馈的效果:一项随机对照试验的研究方案

Effects of heart rate variability biofeedback during exposure to fear-provoking stimuli within spider-fearful individuals: study protocol for a randomized controlled trial.

作者信息

Schäfer Sarah K, Ihmig Frank R, Lara H Karen A, Neurohr Frank, Kiefer Stephan, Staginnus Marlene, Lass-Hennemann Johanna, Michael Tanja

机构信息

Division of Clinical Psychology and Psychotherapy, Department of Psychology, Saarland University, Building A 1.3, 66123, Saarbrücken, Germany.

Department of Biomedical Microsystems, Fraunhofer-Institut fuer Biomedizinische Technik (IBMT), Sulzbach, Saar, Germany.

出版信息

Trials. 2018 Mar 16;19(1):184. doi: 10.1186/s13063-018-2554-2.

Abstract

BACKGROUND

Specific phobias are among the most common anxiety disorders. Exposure therapy is the treatment of choice for specific phobias. However, not all patients respond equally well to it. Hence, current research focuses on therapeutic add-ons to increase and consolidate the effects of exposure therapy. One potential therapeutic add-on is biofeedback to increase heart rate variability (HRV). A recent meta-analysis shows beneficial effects of HRV biofeedback interventions on stress and anxiety symptoms. Therefore, the purpose of the current trial is to evaluate the effects of HRV biofeedback, which is practiced before and utilized during exposure, in spider-fearful individuals. Further, this trial is the first to differentiate between the effects of a HRV biofeedback intervention and those of a low-load working memory (WM) task.

METHODS

Eighty spider-fearful individuals participate in the study. All participants receive a training session in which they practice two tasks (HRV biofeedback and a motor pseudo-biofeedback task or two motor pseudo-biofeedback tasks). Afterwards, they train both tasks at home for 6 days. One week later, during the exposure session, they watch 16 1-min spider video clips. Participants are divided into four groups: group 1 practices the HRV biofeedback and one motor pseudo-task before exposure and utilizes HRV biofeedback during exposure. Group 2 receives the same training, but continues the pseudo-biofeedback task during exposure. Group 3 practices two pseudo-biofeedback tasks and continues one of them during exposure. Group 4 trains in two pseudo-biofeedback tasks and has no additional task during exposure. The primary outcome is fear of spiders (measured by the Fear of Spiders Questionnaire and the Behavioral Approach Test). Secondary outcomes are physiological measures based on electrodermal activity, electrocardiogram and respiration.

DISCUSSION

This RCT is the first one to investigate the effects of using a pre-trained HRV biofeedback during exposure in spider-fearful individuals. The study critically contrasts the effects of the biofeedback intervention with those of pseudo-tasks, which also require WM capacity, but which do not have a physiological base. If HRV biofeedback is effective in reducing fear of spiders, it would represent an easy-to-use tool to improve exposure-therapy outcomes.

TRIAL REGISTRATION

Deutsches Register Klinischer Studien, DRKS00012278 . Registered on 23 May 2017, amendment on 5 October 2017.

摘要

背景

特定恐惧症是最常见的焦虑症之一。暴露疗法是治疗特定恐惧症的首选方法。然而,并非所有患者对其反应都同样良好。因此,当前研究聚焦于辅助治疗手段,以增强和巩固暴露疗法的效果。一种潜在的辅助治疗手段是生物反馈,以增加心率变异性(HRV)。最近的一项荟萃分析显示,HRV生物反馈干预对压力和焦虑症状有有益影响。因此,本试验的目的是评估在蜘蛛恐惧症患者中,在暴露前及暴露期间进行的HRV生物反馈的效果。此外,本试验首次区分了HRV生物反馈干预与低负荷工作记忆(WM)任务的效果。

方法

80名蜘蛛恐惧症患者参与了该研究。所有参与者都接受一次培训课程,在课程中他们练习两项任务(HRV生物反馈和一项运动假生物反馈任务或两项运动假生物反馈任务)。之后,他们在家中对这两项任务进行6天的训练。一周后,在暴露环节,他们观看16个1分钟的蜘蛛视频片段。参与者被分为四组:第1组在暴露前练习HRV生物反馈和一项运动假任务,并在暴露期间使用HRV生物反馈。第2组接受相同的训练,但在暴露期间继续进行假生物反馈任务。第3组练习两项假生物反馈任务,并在暴露期间继续其中一项。第4组训练两项假生物反馈任务,在暴露期间不进行额外任务。主要结局是对蜘蛛的恐惧(通过蜘蛛恐惧问卷和行为趋近测试测量)。次要结局是基于皮肤电活动、心电图和呼吸的生理指标。

讨论

这项随机对照试验是首次研究在蜘蛛恐惧症患者暴露期间使用预先训练的HRV生物反馈的效果。该研究严格对比了生物反馈干预与假任务的效果,假任务也需要WM能力,但没有生理基础。如果HRV生物反馈能有效减轻对蜘蛛的恐惧,它将成为一种易于使用的工具,以改善暴露疗法的效果。

试验注册

德国临床试验注册中心,DRKS00012278。于2017年5月23日注册,2017年10月5日修订。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/167e/5857097/9969373a37ef/13063_2018_2554_Fig1_HTML.jpg

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