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Completed

NCT Number: NCT04932369

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotion Regulation training based on DBT

Behavioral

trained about emotion regulation and problem solving during eight 90-min group sessions

Primary outcomes

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

    Time frame: 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

British University In Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2021
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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