- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06207695
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
Recruiting
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Estimated)
50
Phase
- 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
- Name: Cennet Yastıbaş Kaçar, PhD
- Phone Number: +905346320490
- Email: cennetyastibas@gmail.com
Study Locations
-
-
-
Kahramanmaraş, Turkey, 46000
- Recruiting
- Kahramanmaras
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
Investigators
- 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)
October 1, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Estimated)
February 15, 2024
Study Registration Dates
First Submitted
December 18, 2023
First Submitted That Met QC Criteria
January 4, 2024
First Posted (Actual)
January 17, 2024
Study Record Updates
Last Update Posted (Actual)
January 17, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Other Study ID 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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