Ignite Creation Date:
2025-12-24 @ 2:02 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT06207695
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention for Earthquake Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2024-01-04', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in psychological distress', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': 'The Turkish version of General Health Scale 12. Higher scores refer worse psychological distress'}, {'measure': 'Change in Affect', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': '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'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': 'The Turkish version of Short Form-12 will be used. It consisted of 12 items. Higher scores refer higher quality of life.'}, {'measure': 'Change in Self-Efficacy.', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': 'The Turkish Form of Coping Self-Efficacy (tailored earthtquake) will be used. Higher scores are a clear sign of higher coping self-efficacy.'}, {'measure': 'Change in Resilience', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': 'The Turkish form of resilience will be used. Higher scores refer higher resilience scores.'}, {'measure': 'Change in anxiety', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': 'The Turkish version of Generalized Anxiety Disorder-7 will be used. Higher scores refer higher anxiety'}, {'measure': 'Change in depression', 'timeFrame': 'Baseline measurement before the intervention begin (pre-intervention), immediately after the completion of the intervention (post-intervention)', 'description': 'The Turkish Form of Patient Health Questionnaire. It contains 9 item referring depressive symptoms. High scores are a clear sign of depression.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['earthquake', 'group intervention', 'psychological distress'], 'conditions': ['Earthquake']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experienced the 6th of February Earthquake in Kahramanmaraş\n* Being literate or above\n* Being volunteer to participate in group intervention\n\nExclusion Criteria:\n\n* Having any current psychological treatment related to earthquake\n* Being illiteracy'}, 'identificationModule': {'nctId': 'NCT06207695', 'acronym': 'BriefGroup', 'briefTitle': 'Intervention for Earthquake Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'A Brief Group Psychosocial Intervention for Earthquake Survivors: Kahramanmaras Earthquakes', 'orgStudyIdInfo': {'id': 'Interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Psychosocial Intervention', 'description': 'The group was leaded by two psychologists trained on trauma and disaster psychology, and group intervention. Each groups lasted 2.50 hours.', 'interventionNames': ['Behavioral: Brief Group Intervention']}], 'interventions': [{'name': 'Brief Group Intervention', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Brief Psychosocial Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Kahramanmaraş', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'facility': 'Kahramanmaraş', 'geoPoint': {'lat': 37.5847, 'lon': 36.92641}}], 'centralContacts': [{'name': 'Cennet Yastıbaş Kaçar, PhD', 'role': 'CONTACT', 'email': 'cennetyastibas@gmail.com', 'phone': '+905346320490'}], 'overallOfficials': [{'name': 'Cennet Yastıbaş Kaçar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adana Alparslan Turkes Science and Technology University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Psychologist, PhD', 'investigatorFullName': 'Cennet Yastıbaş', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}