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临床试验/NCT06156852
NCT06156852已完成不适用

A Randomized Clinical Trial Comparing the Effects of Mindfulness-Based Stress Reduction and Cognitive Behavioral Therapy-Based Stress Reduction in Medical Students

Gazi University2 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
253
试验地点
2
主要终点
Anxiety level

研究概览

简要总结

We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and perceived stress of medical students.

323 medical students applied to participate in one of the group interventions and were assessed with the Mini International Neuropsychiatric Interview. Of these, 253 (77% female, mean age=21.9 ± 2.9 years) were allocated into online MBSR (n=127) and online CBSR (n=126) groups after randomization. Their anxiety and depressive symptoms and perceived stress levels were assessed at baseline and after 8 weeks of interventions.

详细描述

Objective: Medical students face an enormous amount of stress. They suffer from higher rates of depression, anxiety, and suicide compared to the general population. Despite experiencing more mental health problems, there is a lack of research exploring ways to improve their mental health. Although there are a few small sample studies investigating the effectiveness of Mindfulness-Based Stress Reduction (MBSR) on medical students, there is no study comparing its effectiveness against an active intervention group in the literature.

Aim: We aimed to compare the effects of the Mindfulness-Based Stress Reduction (MBSR) and the Cognitive Behavioural Stress Reduction (CBSR) group interventions on depression and anxiety symptoms and the perceived stress level of medical students.

Methods: The medical students who studied in medical faculties in Ankara/Turkey were asked to participate in our study. In order to invite students to the study, posters announcing our study were put on the boards of the lecture halls of medical faculties, and our posters were shared on social media platforms where these students were involved. After receiving applications from a sufficient number of students who volunteered to participate in the study, the students were assessed online with Mini International Neuropsychiatric Interview by a senior psychiatry resident. Medical students who were eligible to take part in the study were asked to fill out the forms (sociodemographic data form) and scales (Hospital Anxiety-Depression Scale, Perceived Stress Scale) within one week before being allocated into groups. After the students were randomized into two groups with the help of a computer program, stress reduction interventions were conducted for 8 weeks in groups of 10-12 students. After enough participants volunteered to participate in the study, the participants were recruited mainly in two groups and randomized as they were recruited. The first group consisted of 157 participants and the second group consisted of 96 participants. When the group interventions were completed at the end of 8 weeks, the participants were asked to complete the scales (Hospital Anxiety-Depression Scale, Perceived Stress Scale) within one week.

Inclusion Criteria:

  • Being a medical student at a university in Ankara
  • Being older than 18 years old
  • Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
  • Volunteering to participate in the study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a medical student at a university in Ankara
  • Being older than 18 years old
  • Not having participated in mindfulness-based or cognitive behavioral stress reduction groups or individual therapies
  • Volunteering to participate in the study

排除标准

  • Having known mindfulness-based stress reduction methods and applied them in their lives
  • Having known cognitive behavioral stress reduction methods and applied them in their lives
  • Depression and mania severe enough to prevent their participation in the study
  • High risk of suicide
  • Having a chronic physical condition that may prevent participation in the study
  • History of psychotic disorder and/or meeting the diagnosis of psychotic disorder at the assessment stage

结局指标

主要结局

Anxiety level

时间窗: 8 weeks

Anxiety symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.

Depressive symptom level

时间窗: 8 weeks

Depressive symptom levels were assessed with the Hospital anxiety and depression scale (HADS). This scale is a self-assessment scale developed to determine the risk of anxiety and depression in patients with physical illness and primary health care patients and to measure their level and change in severity.

Perceived stress level

时间窗: 8 weeks

Perceived stress levels were assessed with the Perceived Stress Scale (PSS). This is a widely used scale to assess the effects of different situations on our emotions and perceived stress.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aysegul Yay

Research assistant

Gazi University

研究点 (2)

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