基于互联网的大学生心理症状跨诊断干预：发展、可用性和有效性评价：研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-06 DOI:10.1016/j.conctc.2025.101443

Ömer Özer , Gizem Öztemür , Ali Ercan Altinöz , Burak Köksal , Uğur Doğan , Sedat Batmaz , Recep Gür , Ahmet Altinok

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引用次数: 0

摘要

大学生经常面临重大的心理健康挑战，包括抑郁、焦虑和适应困难，这些挑战可能会被独立生活的要求和生活责任的增加所夸大。这些挑战往往因寻求帮助的障碍而复杂化，例如耻辱和获得大学资源的机会有限，这可能进一步恶化学生的福祉。本协议旨在帮助大学生克服这些障碍，并评估与对照组相比，基于跨诊断CBT （UNIPDES）的有指导和无指导在线干预平台对抑郁、焦虑和适应水平的影响。该研究的计算样本量将包括330名学生，参与者将从位于日本的五所不同的大学中选出。参与者将被随机分配到指导组、非指导组和对照组。有指导组和无指导组的参与者将接受六周的干预，等待名单对照组将在12周的随机化后接受无指导版本的程序。评估将在基线、测试后（基线后8周）和随访（基线后12周）进行。采用混合方差分析（Mixed ANOVA）对数据进行分析，以组（引导、非引导、对照）为受试者间因素，时间（基线、后测、随访）为受试者内因素，评估组和时间对主要结局——抑郁、焦虑和调整水平变化的交互作用。此外，学生的退学原因将被定性评估。本研究结果可为跨诊断导向与非导向网络干预治疗学生抑郁、焦虑与适应问题的有效性提供证据。发展和发展方案可以为学生普遍面临的问题提供灵活、易于获得和具有成本效益的治疗方法。试验注册在ClinicalTrials.gov方案注册和结果系统上注册（试验编号：NCT06245200）。

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UNIPDES - An internet-based transdiagnostic intervention for college students’ psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol

University students often face significant mental health challenges, including depression, anxiety, and difficulties in adjustment, which can be exaggerated by the demands of independent living and increased life responsibilities. These challenges are often compounded by barriers to seeking help, such as stigma and limited access to university resources, which can further deteriorate students' well-being. This protocol was created to assist college students in overcoming these obstacles and to assess, in comparison to a control group, the impact of a guided and unguided online intervention platform based on transdiagnostic CBT (UNIPDES) on depression, anxiety, and adjustment levels. The calculated sample size for the study will include 330 students, and the participants will be selected from five different universities located in Türkiye. Participants will be randomly assigned to either guided, unguided, or control groups. Guided and unguided group participants will receive six weeks of intervention, and the waitlist control group will receive the unguided version of the program after twelve weeks of randomization. Assessments will take place at baseline, post-test (8 weeks post-baseline) and follow-up (12 weeks post-baseline). A Mixed ANOVA will be employed to analyze the data, with Group (Guided, Unguided, Control) as the between-subjects factor and Time (Baseline, Post-Test, Follow-Up) as the within-subjects factor, as well as to assess the interaction effect between Group and Time on the primary outcomes—changes in depression, anxiety, and adjustment levels. Additionally, students’ reasons for dropout will be assessed qualitatively. The results from this study can build evidence for the effectiveness of transdiagnostic guided and unguided internet-based intervention for treating depression, anxiety, and adjustment problems of students. UNIPDES can provide a flexible, easy-to-access, and cost-effective treatment for the problems that students commonly face. Trial registration is registered at ClinicalTrials.gov Protocol Registration and Results System (Trial number: NCT06245200).

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.