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

• Sponsor: British University In Egypt (Other)
• Overall Status: Completed
• CT.gov ID: NCT04932369
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site Per Month: 15.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety; Emotion Regulation	Behavioral: Emotion Regulation training based on DBT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt During COVID-19
• Actual Study Start Date: Apr 1, 2021
• Actual Primary Completion Date: May 1, 2022
• Actual Study Completion Date: May 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The British university in Egypt	Cairo		Egypt	11837

Sponsors and Collaborators

• British University In Egypt

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Amani Safwat Albrazi, Dr, British University In Egypt
• ClinicalTrials.gov Identifier: NCT04932369
• Other Study ID Numbers: CL-2008
• First Posted: Jun 21, 2021
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Amani Safwat Albrazi, Dr, British University In Egypt: University's students; COVID-19
• Additional relevant MeSH terms: Anxiety Disorders

Study Results

No Results Posted as of Jul 11, 2022