The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932369
• Other study ID #: CL-2008
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 1, 2022

Study information

• Verified date: July 2022
• Source: British University In Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

Inclusion Criteria:

• Being an active student at the University

Exclusion Criteria:

1. Receiving treatment at the hospital during the time that the study was in progress

2. Having been diagnosed with psychotic disorders

3. Having mental retardation

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Emotion Regulation

Intervention

Behavioral:
• Emotion Regulation training based on DBT
trained about emotion regulation and problem solving during eight 90-min group sessions

Locations

Country	Name	City	State
Egypt	The British university in Egypt	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
British University In Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in anxiety from Baseline to the completion of training three months later using Beck Anxiety Inventory (BAI)	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	3 months. Assessments of anxiety will be collected from all students two times, three months apart
Primary	Change in difficulties in emotion regulation from Baseline to the completion of training three months later using Emotion regulation difficulties Scale	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.	3 months. Assessments of DER will be collected from all students two times, three months apart