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REVISIT-BPD试验方案,一项随机对照试验,旨在测试基于互联网的自我管理干预措施在治疗边缘性人格障碍(BPD)中的有效性。

Protocol for the REVISIT-BPD Trial, a Randomized Controlled Trial Testing the Effectiveness of an Internet-Based Self-Management Intervention in the Treatment of Borderline Personality Disorder (BPD).

作者信息

Klein Jan Philipp, Hauer Andrea, Berger Thomas, Fassbinder Eva, Schweiger Ulrich, Jacob Gitta

机构信息

Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.

Gaia AG, Hamburg, Germany.

出版信息

Front Psychiatry. 2018 Sep 21;9:439. doi: 10.3389/fpsyt.2018.00439. eCollection 2018.

Abstract

Borderline Personality Disorder (BPD) is a prevalent condition that is often under-treated. This is partly because very few psychotherapists offer treatment for this disabling disorder. Internet-based self-management interventions could contribute to reducing the treatment gap but-mainly due to safety concerns-these have never been tested for BPD in controlled trials. Patients with BPD will be recruited primarily via the internet and randomized to two groups: care as usual (CAU) alone) or the self-management intervention ® in addition to CAU. At the end of the diagnostic interview, all participants will discuss an emergency plan. The main outcome measure is the clinician-rated symptom severity using the BPD Severity Index (BPDSI). Secondary outcome measures include a range of self-reported scales, an SCID-diagnosis of BPD and several safety parameters including serious adverse events (e.g., a life-threatening event, hospitalization or suicide attempt). This trial will evaluate the effectiveness of the self-management intervention, , in reducing symptoms of BPD. It will also assess the safety of its use in this target population. If successful, this intervention would be the first comprehensive internet intervention for the treatment of BPD and complement the wide range of internet interventions effective in treating other mental disorders, particularly depression and anxiety disorders. NCT03418142 (clinicaltrials.gov) on January 23rd 2018. recruiting, currently = 108 (July 2018).

摘要

边缘型人格障碍(BPD)是一种普遍存在但往往治疗不足的病症。部分原因在于很少有心理治疗师提供针对这种致残性疾病的治疗。基于互联网的自我管理干预措施可能有助于缩小治疗差距,但主要出于安全考虑,这些措施从未在对照试验中针对BPD进行过测试。患有BPD的患者将主要通过互联网招募,并随机分为两组:仅接受常规护理(CAU)或在接受CAU的基础上接受自我管理干预。在诊断访谈结束时,所有参与者将讨论一份应急计划。主要结局指标是使用BPD严重程度指数(BPDSI)由临床医生评定的症状严重程度。次要结局指标包括一系列自我报告量表、BPD的SCID诊断以及包括严重不良事件(如危及生命的事件、住院或自杀未遂)在内的几个安全参数。这项试验将评估自我管理干预在减轻BPD症状方面的有效性。它还将评估在该目标人群中使用该干预措施的安全性。如果成功,这种干预将是首个用于治疗BPD的全面互联网干预措施,并补充了有效治疗其他精神障碍,特别是抑郁症和焦虑症的广泛互联网干预措施。2018年1月23日在clinicaltrials.gov上注册,编号为NCT03418142。正在招募,目前已招募108人(2018年7月)。

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