Intervention for Earthquake Survivors (BriefGroup)

January 4, 2024 updated by: Cennet Yastıbaş, Dokuz Eylul University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Kahramanmaraş, Turkey, 46000
        • Recruiting
        • Kahramanmaraş

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Experienced the 6th of February Earthquake in Kahramanmaraş
  • Being literate or above
  • Being volunteer to participate in group intervention

Exclusion Criteria:

  • Having any current psychological treatment related to earthquake
  • Being illiteracy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Brief Psychosocial Intervention
The group was leaded by two psychologists trained on trauma and disaster psychology, and group intervention. Each groups lasted 2.50 hours.
Behavioral: Brief Group Intervention
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
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
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
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.
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
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.
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
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.
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
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
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)
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.
Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Cennet Yastıbaş Kaçar, PhD, Adana Alparslan Turkes Science and Technology University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Interventional (Oncolys BioPharma Inc)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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