针对日本强迫症患者的基于互联网的指导性认知行为疗法：一项随机对照试验方案

Guided Internet-Based Cognitive Behavioral Therapy in Japanese Patients With Obsessive-Compulsive Disorder: Protocol for a Randomized Controlled Trial.

作者信息

Matsumoto Kazuki, Hamatani Sayo, Makino Takuya, Uemura Taku, Suzuki Futoshi, Shinno Seina, Ikai Tomoki, Hayashi Hiroyuki, Sutoh Chihiro, Shimizu Eiji

机构信息

Research Center for Child Mental Development, Chiba University, Chiba, Japan.

Japan Society for the Promotion of Science, Tokyo, Japan.

出版信息

JMIR Res Protoc. 2020 Jun 24;9(6):e18216. doi: 10.2196/18216.

DOI:10.2196/18216

PMID:32442142

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7381023/

Abstract

BACKGROUND

Cognitive behavioral therapy for obsessive-compulsive disorder has been established, but access to this therapy in Japan is limited. Internet-based cognitive behavioral therapy may improve treatment accessibility and sufficiently improve obsessive-compulsive symptoms. There are few randomized controlled trials examining the effectiveness of internet-based cognitive behavioral therapy in patients with obsessive-compulsive disorder. We designed a randomized controlled trial protocol to assess the effectiveness of guided internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder.

OBJECTIVE

We aimed to develop a protocol for a randomized controlled trial of internet-based cognitive behavioral therapy in Japanese patients with obsessive-compulsive disorder.

METHODS

The randomized controlled trial will compare internet-based cognitive behavioral therapy treatment and usual care groups, each consisting of 15 participants (n=30) diagnosed with obsessive-compulsive disorder. We will evaluate the effectiveness of a 12-week intervention. The primary outcome of symptom severity will be measured using the Yale-Brown Obsessive-Compulsive Scale. Secondary outcomes will be assessed with the Obsessive-Compulsive Inventory, Beck Anxiety Inventory, Patient Health Questionnaire-9, Generalized Anxiety Disorder-7, Working Alliance Inventory-Short Form, and the Euro Qol - 5 Dimension. All measures will be assessed at weeks 0 (baseline) and 12 (follow-up). In the statistical analysis comparing treatment effects, the least-squares means and their 95% CIs will be estimated by analysis of covariance with the change in total outcomes scores at week 12. All comparisons are planned, and all P values will be two-sided, with values <.05 considered statistically significant.

RESULTS

The study will be performed from January 2020 to March 2021, and results are expected to be available in mid-2021.

CONCLUSIONS

The trial will demonstrate whether internet-based cognitive behavioral therapy improves access and is more effective than more usual care for patients with obsessive-compulsive disorder in Japan.

TRIAL REGISTRATION

University Hospital Medical Information Network (UMIN) 000039375; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044422.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18216.

摘要

背景

针对强迫症的认知行为疗法已确立，但在日本，获得这种疗法的途径有限。基于互联网的认知行为疗法可能会提高治疗的可及性，并充分改善强迫症状。很少有随机对照试验研究基于互联网的认知行为疗法对强迫症患者的有效性。我们设计了一项随机对照试验方案，以评估指导性基于互联网的认知行为疗法对日本强迫症患者的有效性。

目的

我们旨在制定一项针对日本强迫症患者的基于互联网的认知行为疗法随机对照试验方案。

方法

该随机对照试验将比较基于互联网的认知行为疗法治疗组和常规护理组，每组由15名被诊断为强迫症的参与者组成（n = 30）。我们将评估为期12周干预措施的有效性。症状严重程度的主要结局将使用耶鲁-布朗强迫症量表进行测量。次要结局将通过强迫观念及强迫行为问卷、贝克焦虑量表、患者健康问卷-9、广泛性焦虑障碍量表-7、工作联盟量表简版和欧洲五维健康量表进行评估。所有测量将在第0周（基线）和第12周（随访）进行。在比较治疗效果的统计分析中，将通过协方差分析估计最小二乘均值及其95%置信区间，协变量为第12周总结局得分的变化。所有比较均为预先计划好的，所有P值将为双侧，P值<.05被认为具有统计学意义。