跳至主要内容
临床试验/NCT04932369
NCT04932369已完成不适用

The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt During COVID-19

British University In Egypt2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021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
200
试验地点
2
主要终点
Change in anxiety from Baseline to the completion of training three months later using Beck Anxiety Inventory (BAI)

研究概览

简要总结

The important role of Emotion Regulation (ER) in managing stress and anxiety is well recognized. Aims: 1) assessing the level of anxiety, and the level of difficulties in emotion regulation (DER) among University Students during COVID-19, 2) investigating the effect of the emotional regulation training program on the anxiety of University Students during the COVID-19. Methods: Part I, students will be assessed for their anxiety, DER, and the general impact of COVID-19 on their lives. The students will complete Beck Anxiety Inventory (BAI) and Difficulties in Emotion Regulation Scale (DERS). Part II will be a Randomized Control Trial (RCT) using a pre-assessment and a post-assessment. A voluntary sample of students will randomly assigned to either a group that will receive emotion regulation training or a control group. The training program is an adapted version of DBT skills training. The training program will include mindfulness, emotion regulation, and problem-solving skills through eight 90- min group sessions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Being an active student at the University

排除标准

  • Receiving treatment at the hospital during the time that the study was in progress
  • Having been diagnosed with psychotic disorders
  • Having mental retardation

结局指标

主要结局

Change in anxiety from Baseline to the completion of training three months later using Beck Anxiety Inventory (BAI)

时间窗: 3 months. Assessments of anxiety will be collected from all students two times, three months apart

Beck Anxiety Inventory (BAI): was developed by Dr. Aaron T. Beck and it is a brief measure of anxiety with a focus on somatic symptoms of anxiety such as nervousness, dizziness, inability to relax (Beck et al., 1988). It has a total of 21 items that takes approximately 10-15 minutes to complete. Answers are on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The values for each item are added together to get an overall or total score for all 21 symptoms that can vary from 0 to 63 points. A total score of 0 - 7 indicates "Minimal" anxiety; 8 - 15 indicates "Mild" anxiety; 16 -25 indicates "Moderate" anxiety; and 26 - 63 indicates "Severe" anxiety

Change in difficulties in emotion regulation from Baseline to the completion of training three months later using Emotion regulation difficulties Scale

时间窗: 3 months. Assessments of DER will be collected from all students two times, three months apart

The DERS is a 36-item self-reported questionnaire that assesses an individual's ability to regulate their emotions (Gratz \& Roemer, 2004). Participants rate items on a 5-point Likert scale (1 = seldom to 5 = nearly frequently) to represent their self-perceived reactions to stressful emotional situations. The DERS produces an overall difficulty score in ER as well as six subscales: (a) Awareness, (b) Clarity, (c) Nonacceptance, (d) Impulsivity, (e) Goals, and (f) Strategies. Subscales are evaluated in such a way that higher values imply more difficulty.

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

Amani Safwat Albrazi

Dr

British University In Egypt

研究点 (2)

Loading locations...

相似试验