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

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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Emotion Regulation
• Intervention / Treatment: Behavioral: Emotion Regulation training based on DBT

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11837
    • The British University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ER GROUP; The training sessions were based on the Dialectical Behavior Therapy Skills (Linehan, 2015). Each group received eight 90-min sessions of the emotion regulation training (one session per week) carried out by qualified clinical psychologist. The training includes group gathering, homework and telephone consultation as needed.	Behavioral: Emotion Regulation training based on DBT; trained about emotion regulation and problem solving during eight 90-min group sessions
No Intervention: Control group; They completed two assessments, 3-months apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: British University In Egypt
• Investigators: Principal Investigator: Amani Elbarazi, Ph.D., The British University in Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: June 12, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; University's students
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: CL-2008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No