AnxietyNCT04932369
The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt
A study testing Emotion Regulation training based on DBT in people with Anxiety and Emotion Regulation, run by British University In Egypt at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Emotion Regulation
- What is being tested?
- Emotion Regulation training based on DBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being an active student at the University
Who cannot join
- Receiving treatment at the hospital during the time that the study was in progress
- Having been diagnosed with psychotic disorders
- Having mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt During COVID-19
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
- Being tested
- Emotion Regulation training based on DBT
- Keywords
- University's students, COVID-19
- Medical subject headings
- Anxiety Disorders, Emotional Regulation, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Regulation training based on DBTBehavioural
trained about emotion regulation and problem solving during eight 90-min group sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Emotion Regulation training based on DBT |
| Control group | No intervention | They completed two assessments, 3-months apart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 months. Assessments of DER will be collected from all students two times, three months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Apr 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- British University In Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Safwat Albrazi, British University In Egypt
- Investigators
- Amani Elbarazi, Ph.D., Principal investigator, British University In Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932369
- Sponsor's protocol ID
- CL-2008
- Status last verified
- Jul 2022
- First submitted
- 12 Jun 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Emotion Regulation Training on Anxiety, in College Students in Egypt During COVID-19
- ClinicalTrials.gov ID
- NCT04932369
- Acronym / sponsor ID
- CL-2008
- Conditions
- Anxiety, Emotion Regulation
- Keywords
- University's students, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- British University In EgyptUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ER GROUP | Experimental | Behavioral: Emotion Regulation training based on DBTThe 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. |
| Control group | No intervention | –They completed two assessments, 3-months apart |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Being an active student at the University
Key exclusion criteria (3 listed)
- Receiving treatment at the hospital during the time that the study was in progress
- Having been diagnosed with psychotic disorders
- Having mental retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotion Regulation training based on DBTtrained about emotion regulation and problem solving during eight 90-min group sessions | Behavioural | ER GROUP |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amani Elbarazi, Ph.D. principal investigator
British University In Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Regulation training based on DBT in people with Anxiety and Emotion Regulation, run by British University In Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.