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自我引导的虚拟现实数字化治疗惊恐障碍和广场恐惧症:一项随机对照试验研究方案。

Self-guided digital treatment with virtual reality for panic disorder and agoraphobia: a study protocol for a randomized controlled trial.

机构信息

Department of Clinical Psychology and Psychotherapy, University of Siegen, Obergraben 23, 57072, Siegen, Germany.

出版信息

Trials. 2022 May 21;23(1):426. doi: 10.1186/s13063-022-06366-x.

Abstract

BACKGROUND

Cognitive behavioral therapy is the first-line treatment for patients with panic disorder (PD) and agoraphobia (AG). Yet, many patients remain untreated due to limited treatment resources. Digital self-guided short-term treatment applications may help to overcome this issue. While some therapeutic applications are already supported by health insurance companies, data on their efficacy is limited. The current study investigates the effect of self-guided digital treatment comprising psychoeducation and virtual reality exposure therapy (VRET).

METHODS

Thirty patients diagnosed with PD, AG, or panic disorder with agoraphobia (PDA) will be randomly assigned to either the experimental group (EG) or the control group (CG). Participants of both groups will undergo baseline diagnostics in the first two sessions. The subsequent treatment for the EG consists of a self-guided 6-week phase of application-based psychoeducation, one therapy session preparing for the VRET, and 4 weeks of application-based self-guided VRET. To control for the potential effects of the therapy session with the therapist, the CG will receive relaxation and stress-reduction training instead. All patients will then undergo a closing session which terminates with the post-assessment (~ 10 weeks after baseline assessment) and a follow-up assessment 6 weeks following the closing session. Symptom severity (primary outcome) will be assessed at baseline, interim, post-treatment, and follow-up. Additionally, remission status (secondary outcome) will be obtained at follow-up. Both measures will be compared between the groups.

DISCUSSION

The current study aims at providing insights into the efficacy of short-term treatment applications including psychoeducation and self-guided VRET. If successful, this approach might be a feasible and promising way to ease the burden of PD, AG, and PDA on the public health system and contribute to a faster access to treatment.

TRIAL REGISTRATION

ISRCTN ISRCTN10661970 . Prospectively registered on 17 January 2022.

摘要

背景

认知行为疗法是惊恐障碍(PD)和广场恐惧症(AG)患者的一线治疗方法。然而,由于治疗资源有限,许多患者仍未得到治疗。数字自我引导的短期治疗应用程序可能有助于克服这个问题。虽然一些治疗应用程序已经得到了健康保险公司的支持,但关于它们疗效的数据有限。目前的研究调查了自我引导的数字治疗(包括心理教育和虚拟现实暴露疗法(VRET))的效果。

方法

将 30 名被诊断为 PD、AG 或惊恐障碍伴广场恐惧症(PDA)的患者随机分配到实验组(EG)或对照组(CG)。两组参与者都将在前两次会议中进行基线诊断。随后,EG 的治疗包括为期 6 周的基于应用程序的心理教育自我引导阶段、一次准备 VRET 的治疗会议和 4 周的基于应用程序的自我引导 VRET。为了控制与治疗师的治疗会议的潜在影响,CG 将接受放松和减压训练。所有患者将在结束会议后进行评估(大约在基线评估后 10 周),并在结束会议后 6 周进行随访评估。症状严重程度(主要结果)将在基线、中期、治疗后和随访时进行评估。此外,在随访时将获得缓解状态(次要结果)。两组之间将比较这两个措施。

讨论

目前的研究旨在深入了解包括心理教育和自我引导 VRET 在内的短期治疗应用程序的疗效。如果成功,这种方法可能是一种可行且有前途的方法,可以减轻 PD、AG 和 PDA 对公共卫生系统的负担,并有助于更快地获得治疗。

试验注册

ISRCTN ISRCTN86253638。于 2022 年 1 月 17 日前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d334/9123669/3633a65f2156/13063_2022_6366_Fig1_HTML.jpg

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