EarthquakeBriefGroupNCT06207695
Intervention for Earthquake Survivors
A study testing Brief Group Intervention in people with Earthquake, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This program for adults in need of psychological support in earthquake stricken area, Kahramanmaraş, consisted of a brief four-session group psychosocial support intervention. The aim of the project was to test the effectiveness of the intervention program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Earthquake
- What is being tested?
- Brief Group Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 15 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Experienced the 6th of February Earthquake in Kahramanmaraş
- Being literate or above
- Being volunteer to participate in group intervention
Who cannot join
- Having any current psychological treatment related to earthquake
- Being illiteracy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kahramanmaraş
Kahramanmaraş, 46000
About this study
Official title: A Brief Group Psychosocial Intervention for Earthquake Survivors: Kahramanmaras Earthquakes
This program for adults in need of psychological support in earthquake stricken area, Kahramanmaraş, consisted of a brief four-session group psychosocial support intervention. The aim of the project was to test the effectiveness of the intervention program. Intervention program was developed by the psychotherapists, a clinical psychologist holding a PhD degree and a psychiatrist. The general theme was about the strengthening of the personal resources including both external and internal resources. The content of the intervention program is based on the relevant literature.
Read the detailed description
The 6th of February 2023 earthquakes directly affected 11 provinces of our country and were caused thousands loss of life. Trauma in individuals directly affected by the earthquake Post-Traumatic Stress Disorder, depression, anxiety and various psychological problems. These serious psychological problems affect people's functionality significantly and make daily life more difficult. According to the literature, it is seen that various psychosocial support program for earthquake survivors were applied to improve psychological well-being. The results of these interventions demonstrated the psychosocial interventions were effective to diminish psychological distress. Various organisations and communities have continued to provide psychosocial supports peculiar to the needs of individuals living in earthquake stricken areas for the past eight months after the 6th of February 2023 earthquakes. However, the size of the disaster area and the number of people affected is quite high. Thus, a culturally appropriate group of psychosocial intervention program is needed. In this context, the existing research aiming to reduce psychological distress and improve quality of life in the disaster area were examined by the researchers. A brief psychosocial group intervention was developed. This group intervention aiming to strength resources of individuals consisted of four sessions including psychoeducation of the effects of earthquakes, practicing emotion regulation strategies, mindful techniques. The researchers aimed to test the efficacy of this brief psychosocial group intervention. The researchers used a number of measurement tools including psychological distress, quality of life and resilience.
- Conditions
- Earthquake
- Being tested
- Brief Group Intervention
- Keywords
- earthquake, group intervention, psychological distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Group InterventionBehavioural
This brief intervention consisted of four sessions. The contents of sessions were psychoeducation, emotion processing, practicing emotion regulation strategies, cognitive processing, reframing thoughts, practicing mindful exercises, strength social support networks, and problem management skills.
| Study group | Role | What they receive |
|---|---|---|
| Brief Psychosocial Intervention | Experimental | The group was leaded by two psychologists trained on trauma and disaster psychology, and group intervention. Each groups lasted 2.50 hours. Receives: Behavioral: Brief Group Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychological distress
The Turkish version of General Health Scale 12. Higher scores refer worse psychological distress
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Change in Affect
The Turkish version of Positive and Negative Affect Scale. It consists of positive and negative affect.Higher scores of each subscales refer higher level of each of them
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Change in Quality of Life
The Turkish version of Short Form-12 will be used. It consisted of 12 items. Higher scores refer higher quality of life.
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Change in Self-Efficacy.
The Turkish Form of Coping Self-Efficacy (tailored earthtquake) will be used. Higher scores are a clear sign of higher coping self-efficacy.
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Change in Resilience
The Turkish form of resilience will be used. Higher scores refer higher resilience scores.
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Change in anxiety
The Turkish version of Generalized Anxiety Disorder-7 will be used. Higher scores refer higher anxiety
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Change in depression
The Turkish Form of Patient Health Questionnaire. It contains 9 item referring depressive symptoms. High scores are a clear sign of depression.
Measured: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion15 Feb 2024 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cennet Yastıbaş, Dokuz Eylul University
- Investigators
- Cennet Yastıbaş Kaçar, PhD, Study director, Adana Alparslan Turkes Science and Technology University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207695
- Sponsor's protocol ID
- Interventional
- Acronym
- BriefGroup
- Status last verified
- Jan 2024
- First submitted
- 18 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Group Psychosocial Intervention for Earthquake Survivors: Kahramanmaras Earthquakes
- ClinicalTrials.gov ID
- NCT06207695
- Acronym / sponsor ID
- BriefGroup / Interventional
- Conditions
- Earthquake
- Keywords
- earthquake, group intervention, psychological distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 17 Jan 2024 (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 program for adults in need of psychological support in earthquake stricken area, Kahramanmaraş, consisted of a brief four-session group psychosocial support intervention. The aim of the project was to test the effectiveness of the intervention program. Intervention program was developed by the psychotherapists, a clinical psychologist holding a PhD degree and a psychiatrist. The general theme was about the strengthening of the personal resources including both external and internal resources. The content of the intervention program is based on the relevant literature.
Detailed description
The 6th of February 2023 earthquakes directly affected 11 provinces of our country and were caused thousands loss of life. Trauma in individuals directly affected by the earthquake Post-Traumatic Stress Disorder, depression, anxiety and various psychological problems. These serious psychological problems affect people's functionality significantly and make daily life more difficult. According to the literature, it is seen that various psychosocial support program for earthquake survivors were applied to improve psychological well-being. The results of these interventions demonstrated the psychosocial interventions were effective to diminish psychological distress. Various organisations and communities have continued to provide psychosocial supports peculiar to the needs of individuals living in earthquake stricken areas for the past eight months after the 6th of February 2023 earthquakes. However, the size of the disaster area and the number of people affected is quite high. Thus, a culturally appropriate group of psychosocial intervention program is needed. In this context, the existing research aiming to reduce psychological distress and improve quality of life in the disaster area were examined by the researchers. A brief psychosocial group intervention was developed. This group intervention aiming to strength resources of individuals consisted of four sessions including psychoeducation of the effects of earthquakes, practicing emotion regulation strategies, mindful techniques. The researchers aimed to test the efficacy of this brief psychosocial group intervention. The researchers used a number of measurement tools including psychological distress, quality of life and resilience.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brief Psychosocial Intervention | Experimental | Behavioral: Brief Group InterventionThe group was leaded by two psychologists trained on trauma and disaster psychology, and group intervention. Each groups lasted 2.50 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Experienced the 6th of February Earthquake in Kahramanmaraş
- Being literate or above
- Being volunteer to participate in group intervention
Key exclusion criteria (2 listed)
- Having any current psychological treatment related to earthquake
- Being illiteracy
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 |
|---|---|---|
| Brief Group InterventionThis brief intervention consisted of four sessions. The contents of sessions were psychoeducation, emotion processing, practicing emotion regulation strategies, cognitive processing, reframing thoughts, practicing mindful exercises, strength social support networks, and problem management skills. | Behavioural | Brief Psychosocial Intervention |
Primary outcome
Change in psychological distress
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish version of General Health Scale 12. Higher scores refer worse psychological distress
Change in Affect
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish version of Positive and Negative Affect Scale. It consists of positive and negative affect.Higher scores of each subscales refer higher level of each of them
Change in Quality of Life
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish version of Short Form-12 will be used. It consisted of 12 items. Higher scores refer higher quality of life.
Change in Self-Efficacy.
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish Form of Coping Self-Efficacy (tailored earthtquake) will be used. Higher scores are a clear sign of higher coping self-efficacy.
Change in Resilience
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish form of resilience will be used. Higher scores refer higher resilience scores.
Change in anxiety
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish version of Generalized Anxiety Disorder-7 will be used. Higher scores refer higher anxiety
Change in depression
Time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
The Turkish Form of Patient Health Questionnaire. It contains 9 item referring depressive symptoms. High scores are a clear sign of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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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.
Cennet Yastıbaş Kaçar, PhD study director
Adana Alparslan Turkes Science and Technology 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 Brief Group Intervention in people with Earthquake, run by Dokuz Eylul 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cennet Yastıbaş Kaçar, PhD (+905346320490, cennetyastibas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychological distress (time frame: Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)). The study lists 7 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 17 Jan 2024.