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

Study Overview
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Brief Summary
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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.

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

Conditions
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Anxiety, Emotion Regulation

Intervention / Treatment
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* Behavioral: Emotion Regulation training based on DBT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being an active student at the University Exclusion Criteria: Receiving treatment at the hospital during the time that the study was in progress Having been diagnosed with psychotic disorders Having mental retardation

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ER GROUP<br>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<br>* trained about emotion regulation and problem solving during eight 90-min group sessions<br>|
| No Intervention: Control group<br>They completed two assessments, 3-months apart | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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University's students, COVID-19