EarthquakeNCT06045637
The Effect of Psychoeducation on Cognitive Emotion Regulation and Negative Emotional Symptoms
A study testing Group included in a psychoeducational program based on the cognitive behavioral approach (experiment) in people with Earthquake, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned to determine the effect of cognitive behavioral approach-based psychoeducation on the cognitive emotion regulation strategies and negative emotional symptom levels of emerging adults who experienced an earthquake. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Earthquake
- What is being tested?
- Group included in a psychoeducational program based on the cognitive behavioral approach (experiment)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Oct 2023to 25 Dec 2023
- 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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study,
- Being in the 18-29 age group,
- Being at least a primary school graduate,
- Being exposed to/having experienced the Kahramanmaraş earthquake and living in the center of Osmaniye.
Who cannot join
- Having a hearing or speech disability that makes it difficult to answer surveys,
- Participating in a similar psychoeducation program,
- Presence of any psychiatric disorder and receiving treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cognitive Behavioral Approach-based Psychoeducation on the Cognitive Emotion Regulation Strategies and Negative Emotional Symptom Levels of Emerging Adults Who Experienced an Earthquake
This research was planned to determine the effect of cognitive behavioral approach-based psychoeducation on the cognitive emotion regulation strategies and negative emotional symptom levels of emerging adults who experienced an earthquake. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.After the pre-test applied to the experimental and control groups, a 9-session cognitive behavioral approach-based psychoeducation program will be applied to the experimental group.Following this application, post-test and one-month follow-up tests will be administered to both groups and the effectiveness of the psychoeducation program will be compared.
- Conditions
- Earthquake
- Being tested
- Group included in a psychoeducational program based on the cognitive behavioral approach (experiment)
- Keywords
- emerging adulthood, cognitive emotion regulation, negative emotional symptoms, psychoeducation, cognitive behavioral approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group included in a psychoeducational program based on the cognitive behavioral approach (experiment)Behavioural
The 9-session cognitive behavioral approach-based psychoeducation program will last 5 weeks. Sessions; It will be carried out in the form of acquaintance, recognition of trauma and its effects, emotion and thought behavior analysis, cognitive errors, automatic thoughts and alternative thought generation, cognitive emotion regulation strategies, coping with negative emotions, instilling hope and termination session.
| Study group | Role | What they receive |
|---|---|---|
| Group included in a psychoeducational program based on cognitive behavioral approach (experiment) | Experimental | Emerging adults between the ages of 18-29 who experienced the Kahramanmaraş 2023 earthquake in Turkey constitute the experimental group.
The cognitive behavioral approach-based psychoeducation program will be implemented in 9 sessions, two days a week and 90 minutes a day.In the psychoeducation program, based on the cognitive behavioral approach, trauma and trauma symptoms, emotion-thought-behavior analysis, cognitive errors, automatic thoughts, alternative thought generation, mentality and distorted thoughts that reveal feelings of depression, anxiety, stress, anger, guilt, inadequacy, helplessness, The cognitive aspect of hopelessness and methods of coping with negative emotions will be discussed.The training program includes verbal expression, visual material (projection), question and answer, homework, sample stories, entertaining activities, warm-up games, etc. It will be continued and feedback will be shared. Receives: Behavioral: Group included in a psychoeducational program based on the cognitive behavioral approach (experiment) |
| Group not included in the psychoeducation program based on cognitive behavioral approach (Control) | No intervention | No intervention will be made to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive emotion regulation scale
The scale consists of 36 items, with 9 subscales and 4 items in each subscale. Each subscale receives a value between 4-20 points and the scale is a 5-point Likert type scale (1: Never, 2: Sometimes, 47 3: Regularly, 4: Frequently, 5: Always).Evaluation is made with the scores obtained from the subscales. A higher score from a subscale indicates greater use of the cognitive emotion regulation strategy determined by that subscale.
Measured: Two months
Depression, Anxiety, Stress Scale
The scale consists of 21 items, with 3 sub-dimensions (depression, anxiety and stress) and 7 items in each sub-dimension.
The scale is designed as a self-evaluation scale with a 4-point Likert structure scored between 0-4. (0- Never, 1- Sometimes and occasionally, 2- Quite often, 3- Always). The scoring range of the scale for depression is: 0-4 normal, 5-6 mild, 7-10 moderate, 11-13 severe, 14 and above very severe; for anxiety: 0-3 normal, 4-5 mild, 6-7 moderate, 8-9 severe, and 10 and above very severe; For stress: 0-7 is normal, 8-9 is mild, 10-12 is moderate, 13-16 is severe, 17 and above is very severe.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 Oct 2023
- Primary completion24 Nov 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EarthquakeStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research was planned as a randomized controlled experimental study. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osmaniye Korkut Ata University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Çapar, Osmaniye Korkut Ata University
- Investigators
- AHMET ÇAPAR, lecturer, Principal investigator, Osmaniye Korkut Ata University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045637
- Sponsor's protocol ID
- OKU-SBF-AC-01
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2023
- Last updated
- 19 Apr 2024
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Behavioral Approach-based Psychoeducation on the Cognitive Emotion Regulation Strategies and Negative Emotional Symptom Levels of Emerging Adults Who Experienced an Earthquake
- ClinicalTrials.gov ID
- NCT06045637
- Acronym / sponsor ID
- OKU-SBF-AC-01
- Conditions
- Earthquake
- Keywords
- emerging adulthood, cognitive emotion regulation, negative emotional symptoms, psychoeducation, cognitive behavioral approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Osmaniye Korkut Ata UniversityUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 21 Sep 2023 (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.
This research was planned to determine the effect of cognitive behavioral approach-based psychoeducation on the cognitive emotion regulation strategies and negative emotional symptom levels of emerging adults who experienced an earthquake. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.After the pre-test applied to the experimental and control groups, a 9-session cognitive behavioral approach-based psychoeducation program will be applied to the experimental group.Following this application, post-test and one-month follow-up tests will be administered to both groups and the effectiveness of the psychoeducation program will be compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research was planned as a randomized controlled experimental study. In this research, pre-test, post-test and follow-up test will be performed and there will be 1 experimental and 1 control group created by randomization.
| Arm | Type | Receives |
|---|---|---|
| Group included in a psychoeducational program based on cognitive behavioral approach (experiment) | Experimental | Behavioral: Group included in a psychoeducational program based on the cognitive behavioral approach (experiment)Emerging adults between the ages of 18-29 who experienced the Kahramanmaraş 2023 earthquake in Turkey constitute the experimental group. The cognitive behavioral approach-based psychoeducation program will be implemented in 9 sessions, two days a week and 90 minutes a day.In the psychoeducation program, based on the cognitive behavioral approach, trauma and trauma symptoms, emotion-thought-behavior analysis, cognitive errors, automatic thoughts, alternative thought generation, mentality and distorted thoughts that reveal feelings of depression, anxiety, stress, anger, guilt, inadequacy, helplessness, The cognitive aspect of hopelessness and methods of coping with negative emotions will be discussed.The training program includes verbal expression, visual material (projection), question and answer, homework, sample stories, entertaining activities, warm-up games, etc. It will be continued and feedback will be shared. |
| Group not included in the psychoeducation program based on cognitive behavioral approach (Control) | No intervention | –No intervention will be made to this group. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Volunteering to participate in the study,
- Being in the 18-29 age group,
- Being at least a primary school graduate,
- Being exposed to/having experienced the Kahramanmaraş earthquake and living in the center of Osmaniye.
Key exclusion criteria (3 listed)
- Having a hearing or speech disability that makes it difficult to answer surveys,
- Participating in a similar psychoeducation program,
- Presence of any psychiatric disorder and receiving treatment
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 |
|---|---|---|
| Group included in a psychoeducational program based on the cognitive behavioral approach (experiment)The 9-session cognitive behavioral approach-based psychoeducation program will last 5 weeks. Sessions; It will be carried out in the form of acquaintance, recognition of trauma and its effects, emotion and thought behavior analysis, cognitive errors, automatic thoughts and alternative thought generation, cognitive emotion regulation strategies, coping with negative emotions, instilling hope and termination session. | Behavioural | Group included in a psychoeducational program based on cognitive behavioral approach (experiment) |
Primary outcome
cognitive emotion regulation scale
Time frame: Two months
The scale consists of 36 items, with 9 subscales and 4 items in each subscale. Each subscale receives a value between 4-20 points and the scale is a 5-point Likert type scale (1: Never, 2: Sometimes, 47 3: Regularly, 4: Frequently, 5: Always).Evaluation is made with the scores obtained from the subscales. A higher score from a subscale indicates greater use of the cognitive emotion regulation strategy determined by that subscale.
Depression, Anxiety, Stress Scale
Time frame: Two months
The scale consists of 21 items, with 3 sub-dimensions (depression, anxiety and stress) and 7 items in each sub-dimension. The scale is designed as a self-evaluation scale with a 4-point Likert structure scored between 0-4. (0- Never, 1- Sometimes and occasionally, 2- Quite often, 3- Always). The scoring range of the scale for depression is: 0-4 normal, 5-6 mild, 7-10 moderate, 11-13 severe, 14 and above very severe; for anxiety: 0-3 normal, 4-5 mild, 6-7 moderate, 8-9 severe, and 10 and above very severe; For stress: 0-7 is normal, 8-9 is mild, 10-12 is moderate, 13-16 is severe, 17 and above is very severe.
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 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Earthquake
Active, not recruitingObservational study
The Perspectives of Those Who Experienced the Kahramanmaraş Earthquake
Earthquake
Active, not recruiting
Home Visit Simulation-based Earthquake Preparedness Training for Nursing Students
Communication Skills, Self Directed Learning
Active, not recruiting
Effects of the Integrated Grief Therapy on Psychological Resilience, Post-Traumatic Growth, Traumatic Stress, and Grief Processes in Earthquake Survivors
Post-traumatic Stress Disorder (PTSD), Grief (Traumatic Grief and Existential Grief)
Not yet recruiting
Mind-Body Intervention in Earthquake Survivors: 6 mo RCT
Earthquake Victim
Not yet recruiting
Creative Drama on Gender Role Stress, Attitudes Toward Violence Against Women, and Aggression
Gender Role, Aggression
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.
AHMET ÇAPAR, lecturer principal investigator
Osmaniye Korkut Ata University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group included in a psychoeducational program based on the cognitive behavioral approach (experiment) in people with Earthquake, run by Osmaniye Korkut Ata University at 1 site in Turkey (Türkiye).
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 4 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 19 Apr 2024. 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 Turkey (Türkiye). 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?
cognitive emotion regulation scale (time frame: Two months). 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 19 Apr 2024.