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

NCT04932369 | Completed

• 1 other identifier: CL-2008
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Emotion Regulation

Keywords

University's students; COVID-19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

ER GROUP

EXPERIMENTAL

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

Control group

NO INTERVENTION

They completed two assessments, 3-months apart

Interventions

Emotion Regulation training based on DBT BEHAVIORAL

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

ER GROUP

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being an active student at the University

You may not qualify if:

• Receiving treatment at the hospital during the time that the study was in progress
• Having been diagnosed with psychotic disorders
• Having mental retardation

Sponsors & Collaborators

• British University In Egypt: lead

Study Sites (1)

The British university in Egypt

Cairo, 11837, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation; COVID-19

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Amani Elbarazi, Ph.D.

  The British University in Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 21, 2021
• Study Start: April 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)