通过手机应用程序对边缘型人格障碍患者进行症状的每日自我监测和技能学习：一项实用随机对照试验的方案
Daily Self-Monitoring of Symptoms and Skills Learning in Patients With Borderline Personality Disorder Through a Mobile Phone App: Protocol for a Pragmatic Randomized Controlled Trial.
作者信息
Helweg-Jørgensen Stig, Beck Lichtenstein Mia, Fruzzetti Alan E, Møller Dahl Christian, Pedersen Susanne S
机构信息
Research Unit for Telepsychiatry and E-mental Health, Mental Health Services in the Region of Southern Denmark, Odense, Denmark.
Institute of Psychology, University of Southern Denmark, Odense, Denmark.
出版信息
JMIR Res Protoc. 2020 May 25;9(5):e17737. doi: 10.2196/17737.
BACKGROUND
Patient self-monitoring via mobile phones during psychotherapy can enhance and provide an overview of psychotherapeutic progress by graphically displaying current and previous symptom scores, providing feedback to the patient, delivering psychoeducative material, and providing timely data to the therapist or treatment team.
OBJECTIVE
This study will aim to assess the effects of using a mobile phone to self-monitor symptoms and acquire coping skills instead of using pen and paper during psychotherapy in patients with borderline personality disorder (BPD). Dialectical behavior therapy will be performed to treat BPD. The primary outcome is the mean time needed to learn coping skills directed at emotion regulation; the secondary outcome is changes in the BPD symptom score as measured by the Zanarini Rating Scale for Borderline Personality Disorder.
METHODS
This study is a pragmatic, multicenter randomized controlled trial. Participants were recruited through five public general psychiatric outpatient treatment facilities in Denmark. Patients are randomly assigned, on a 1:1 basis, to either the mobile phone condition (using the Monsenso mDiary mobile app) or pen-and-paper condition. Patients will complete several self-report questionnaires on symptom severity; assessments by trained raters on BPD severity will be performed as well. Survival analysis with a shared frailty model will be used to assess the primary outcome.
RESULTS
Recruitment began in June 2017 and was completed in February 2019 after 80 participants were recruited. The study ended in February 2020. It is expected that the benefits of mobile phone-based self-report compared to the pen-and-paper method will be demonstrated for skill learning speed and registration compliance. To our knowledge, this is the first trial exploring the impact of cloud-based mobile registration in BPD treatment.
CONCLUSIONS
This trial will report on the effectiveness of mobile phone-based self-monitoring during psychiatric treatment. It has the potential to contribute to evidence-based clinical practice since apps are already in use clinically.
TRIAL REGISTRATION
ClinicalTrials.gov NCT03191565; https://clinicaltrials.gov/ct2/show/NCT03191565.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17737.
背景
在心理治疗期间，患者通过手机进行自我监测，可通过以图形方式展示当前和以前的症状评分、向患者提供反馈、提供心理教育材料以及向治疗师或治疗团队提供及时数据，来增强并提供心理治疗进展的概述。
目的
本研究旨在评估在边缘型人格障碍（BPD）患者的心理治疗中，使用手机自我监测症状并掌握应对技巧而非使用纸笔的效果。将采用辩证行为疗法治疗BPD。主要结局是学习针对情绪调节的应对技巧所需的平均时间；次要结局是通过边缘型人格障碍 Zanarini 评定量表测量的BPD症状评分的变化。
方法
本研究是一项实用的多中心随机对照试验。通过丹麦的五个公立普通精神科门诊治疗机构招募参与者。患者按 1:1 的比例随机分配到手机组（使用 Monsenso mDiary 移动应用程序）或纸笔组。患者将完成几份关于症状严重程度的自我报告问卷；还将由训练有素的评估人员对BPD严重程度进行评估。将使用共享脆弱模型的生存分析来评估主要结局。
结果
招募工作于2017年6月开始，在招募了80名参与者后于2019年2月完成。该研究于2020年2月结束。预计与纸笔方法相比，基于手机的自我报告在技能学习速度和记录依从性方面的优势将得到证明。据我们所知，这是第一项探索基于云的移动记录在BPD治疗中的影响的试验。
结论
本试验将报告在精神科治疗期间基于手机的自我监测的有效性。由于应用程序已在临床中使用，它有可能为循证临床实践做出贡献。
试验注册
ClinicalTrials.gov NCT03191565；https://clinicaltrials.gov/ct2/show/NCT03191565。
国际注册报告识别码（IRRID）：DERR1-10.2196/17737。
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