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土耳其一项针对抑郁症状的网络和移动引导心理干预的有效性:一项随机对照试验方案

Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial.

作者信息

Ünlü Ince Burçin, Gökçay Didem, Riper Heleen, Cuijpers Pim

机构信息

Department of Medical Informatics / Informatics Institute, Middle East Technical University, Ankara, Turkey.

Ruhuna Iyi Bak, Istanbul, Turkey.

出版信息

JMIR Res Protoc. 2019 Apr 5;8(4):e13239. doi: 10.2196/13239.

Abstract

BACKGROUND

In Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey.

OBJECTIVE

This study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey.

METHODS

Participants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her Şey Kontrol Altında (HŞKA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline).

RESULTS

We will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1).

CONCLUSIONS

Results from this study will reveal more information about the clinical effects of HŞKA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms.

TRIAL REGISTRATION

ClinicalTrials.gov NCT03754829; https://clinicaltrials.gov/ct2/show/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7).

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/13239.

摘要

背景

在土耳其,心理健康护理存在严重不足。尽管抑郁症非常普遍,但只有少数人寻求专业帮助。需要创新解决方案来弥补这一治疗差距。基于网络的问题解决疗法(PST)是一种经证实对治疗抑郁症有效的干预措施,不过其在土耳其的临床效果鲜为人知。

目的

本研究旨在测试一款针对土耳其普通人群抑郁症状的适配性PST网络和移动应用程序的临床效果。

方法

将通过社交媒体和中东技术大学发布的公告招募参与者。年龄在18至55岁之间、有轻度至中度抑郁症状(贝克抑郁量表第二版[BDI-II]得分在10至29之间)的成年人将纳入研究。有中度至高度自杀风险(根据迷你国际神经精神访谈)的参与者将被排除。将采用一项有等待对照组的三臂随机对照试验。444名参与者的样本量将随机分配到3组。第一个实验组将直接获得干预措施的网络版;第二个实验组将直接获得干预措施的移动应用程序以及基于PST的自动支持性短信服务短信。对照组由等待名单组成,将在基线后4个月获得干预措施。该干预基于现有的针对土耳其人群的PST“一切尽在掌控”(HŞKA),由5个模块组成,每个模块为期1周,并由临床心理学家指导。主要结局是用BDI-II测量的抑郁症状变化。次要结局包括焦虑、压力、担忧、自我效能和生活质量的症状。此外,对干预措施的满意度、可用性和可接受性是将被评估的重要特征。所有结局将通过在线自我评估在测试后(基线后6至8周)和随访时(基线后4个月)进行。

结果

我们将从2018年3月至2019年2月或直至招募完成,共招募444名有轻度至中度抑郁症状的参与者。我们预计最终试验结果将于2019年5月底可得。本试验由土耳其科学技术研究理事会资助(2016/1国家博士后研究奖学金计划)。

结论

本研究结果将揭示更多关于HŞKA的临床效果及其在土耳其环境中通过网络和移动平台的适用性的信息。根据结果,基于网络和移动的有指导的PST干预可能成为治疗轻度至中度抑郁症状的合适替代方案。

试验注册

ClinicalTrials.gov NCT03754829;https://clinicaltrials.gov/ct2/show/NCT03754829(由WebCite存档于http://www.webcitation.org/74HugwLo7)。

国际注册报告识别码(IRRID):DERR1-10.2196/13239。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e83d/6473215/5f2fac0724f9/resprot_v8i4e13239_fig1.jpg

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