The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt
Primary Purpose
Anxiety, Emotion Regulation
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Emotion Regulation training based on DBT
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring University's students, COVID-19
Eligibility Criteria
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
Sites / Locations
- The British university in Egypt
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ER GROUP
Control group
Arm Description
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.
They completed two assessments, 3-months apart
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04932369
First Posted
June 12, 2021
Last Updated
July 7, 2022
Sponsor
British University In Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04932369
Brief Title
The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt
Official Title
The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt During COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British University In Egypt
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Emotion Regulation
Keywords
University's students, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ER GROUP
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
They completed two assessments, 3-months apart
Intervention Type
Behavioral
Intervention Name(s)
Emotion Regulation training based on DBT
Intervention Description
trained about emotion regulation and problem solving during eight 90-min group sessions
Primary Outcome Measure Information:
Title
Change in anxiety from Baseline to the completion of training three months later using Beck Anxiety Inventory (BAI)
Description
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
Time Frame
3 months. Assessments of anxiety will be collected from all students two times, three months apart
Title
Change in difficulties in emotion regulation from Baseline to the completion of training three months later using Emotion regulation difficulties Scale
Description
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.
Time Frame
3 months. Assessments of DER will be collected from all students two times, three months apart
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amani Elbarazi, Ph.D.
Organizational Affiliation
The British University in Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
The British university in Egypt
City
Cairo
ZIP/Postal Code
11837
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt
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