Özer Ömer, Öztemür Gizem, Altinöz Ali Ercan, Köksal Burak, Doğan Uğur, Batmaz Sedat, Gür Recep, Altinok Ahmet
Department of Guidance and Psychological Counseling, Anadolu University, Eskisehir, Turkey.
Department of Guidance and Psychological Counseling, Middle East Technical University, Ankara, Turkey.
Contemp Clin Trials Commun. 2025 Feb 6;44:101443. doi: 10.1016/j.conctc.2025.101443. eCollection 2025 Apr.
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).
大学生经常面临重大的心理健康挑战,包括抑郁、焦虑以及适应困难,而独立生活的要求和日益增加的生活责任可能会加剧这些挑战。寻求帮助的障碍,如污名化和获取大学资源的机会有限,往往会使这些挑战更加复杂,进而可能进一步损害学生的幸福感。本方案旨在帮助大学生克服这些障碍,并与对照组相比,评估基于跨诊断认知行为疗法的有指导和无指导在线干预平台(UNIPDES)对抑郁、焦虑和适应水平的影响。该研究计算得出的样本量将包括330名学生,参与者将从土耳其的五所不同大学中选取。参与者将被随机分配到有指导组、无指导组或对照组。有指导组和无指导组的参与者将接受为期六周的干预,等待名单对照组将在随机分组十二周后接受该项目的无指导版本。评估将在基线、测试后(基线后8周)和随访(基线后12周)进行。将采用混合方差分析来分析数据,将组(有指导组、无指导组、对照组)作为组间因素,时间(基线、测试后、随访)作为组内因素,同时评估组和时间对主要结果——抑郁、焦虑和适应水平变化的交互作用。此外,将对学生辍学的原因进行定性评估。本研究的结果可为基于跨诊断的有指导和无指导互联网干预治疗学生抑郁、焦虑和适应问题的有效性提供证据。UNIPDES可以为学生普遍面临的问题提供一种灵活、易于获取且具有成本效益的治疗方法。该试验已在ClinicalTrials.gov方案注册和结果系统中注册(试验编号:NCT0624520)。