跳至主要内容
临床试验/NCT07096154
NCT07096154招募中不适用

Improving Emotional Wellbeing of University Students Using Culturally Adapted Cognitive Behavioural Approaches in Group Settings" (UniWELL-C): Protocol of a Feasibility and Effectiveness Study

Bogazici University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Beck Anxiety Inventory (BAI)

研究概览

简要总结

University students' psychological well-being is a growing public health concern. The university period is a key time for psychological, social, and academic development, which can increase vulnerability to mental health difficulties. Research suggests that group-based Cognitive Behavioural Therapy (CBT) is an effective, cost-efficient option for promoting student well-being. However, tailored interventions that reflect the cultural and contextual needs of specific populations are more likely to be effective. Western-based models of therapy may not always align with the cultural norms and experiences of students in countries like Türkiye.

In Türkiye, publicly accessible mental health services are limited, often reduced to short psychiatric consultations. Psychological therapies are primarily accessed privately, making free or low-cost university mental health services particularly valuable. Therefore, culturally adapted group CBT interventions may play a crucial role in supporting student mental health. This study, part of a larger project, aims to evaluate the effectiveness of CBT-based anxiety groups specifically tailored for Turkish university students.

Eligible participants are Bogazici University students aged 18 and over. Exclusion criteria include severe mental illness, high risk of harm to self or others, or scoring below the threshold on the Beck Anxiety Inventory. These individuals may require more specialized, individual support. The study includes participation in an 8-session CBT-based group focused on anxiety management. Participants may benefit from free psychological support, peer connection, and professional guidance. The study also contributes to the scientific literature by assessing the effectiveness of culturally adapted group interventions.

There are risks: participants may experience distress during sessions or while completing questionnaires. Support will be available from a master's student and/or the group therapist, under the supervision of a qualified clinical psychologist. If a participant's risk increases, they will be supported in accessing psychiatric care. An emergency contact will be required for safety. The study will run at Bogazici University in collaboration with BUREM and the Translational Clinical Psychology Lab, led by Dr. Ayse Akan (t-clinpsylab@bogazici.edu.tr). It is partially funded by Bogazici Scientific Research Projects (20022) and is expected to run for 1-3 years.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Must be a Bogazici University student.
  • •Must be 18 years or older.
  • •Must score above the threshold on the Beck Anxiety Inventory.

排除标准

  • •Not Bogazici University student.
  • •Has serious and severe mental illness.
  • •High risk of self-harm/harm to others.
  • •Scoring below the threshold of the Beck Anxiety Inventory.
  • •Younger than 18 years old.

研究组 & 干预措施

CBT Experimental Arm

Experimental

An 8-session Group Cognitive Behavioural Therapy for anxiety management will be offered to the experimental group of about 40 university students who volunteered and scored above the threshold on the Beck Anxiety Inventory.

干预措施: Group CBT Anxiety Management (Behavioral)

CBT Waitlist Arm

No Intervention

CBT waitlist control

结局指标

主要结局

Beck Anxiety Inventory (BAI)

时间窗: Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention

The Beck Anxiety Inventory (BAI) is a self-report questionnaire that measures the severity of anxiety levels. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severely - it bothered me a lot) resulting in a total score ranging from 0 to 63. Higher scores indicate greater levels of anxiety. The severity is categorized into "minimal", "mild", "moderate", and "severe".

次要结局

  • Depression Anxiety and Stress Scale (DASS42)(Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention)
  • Generalised Anxiety Disorder-7 (GAD7)(Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention)
  • Patient Health Questionnaire (PHQ9)(Baseline, immediately after the intervention, and follow-up 6 weeks after the completion of the intervention)
  • Outcome Rating Scale (ORS)(From enrollment to the end of treatment at 8 weeks)
  • Qualitative data(Up to 12 weeks following the completion of the intervention)

研究者

发起方
Bogazici University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Akan

Assistant Professor and Clinical Psychologist

Bogazici University

研究点 (2)

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